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Anaesthesia
Protocol
Postoperative stellate ganglion block to reduce myocardial injury after laparoscopic radical resection for colorectal cancer: protocol for a randomised trial
  1. Zhouting Hu1,
  2. Wangyu Li2,
  3. Guoqing Zhao3,
  4. Chen Liang4,
  5. Kai Li5
  1. 1Department of Anesthesiology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, People's Republic of China
  2. 2Department of Pain Management, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, People's Republic of China
  3. 3Jilin University, Changchun, Jilin, China
  4. 4New York University, New York, New York, USA
  5. 5Department of Anesthesiology, China-Japan Union Hospital of Jilin University, Changchun, Jilin, People's Republic of China
  1. Correspondence to Dr Kai Li; likai{at}jlu.edu.cn

Abstract

Introduction Stellate ganglion block (SGB) is usually used in the department of algiatry. But preoperative SGB may reduce adverse cardiovascular events in high-risk patients, although evidence remains sparse. Therefore, we aim to determine whether a single-shot postoperative SGB can reduce the incidence of myocardial injury after non-cardiac surgery (MINS) and improve recovery in patients undergoing laparoscopic radical resection for colorectal cancer.

Methods and analysis This is an investigator-initiated, single-centre, randomised, two-arm clinical trial enrolling patients aged over 45 years and scheduled for elective laparoscopic radical colorectal surgery with at least one risk factor for MINS. A total of 950 eligible patients will be randomised into a routine or block groups. The primary outcome is the incidence of MINS. The secondary outcomes include the Visual Analogue Scale of pain during rest and movement, the incidence of delirium, quality of recovery (QOR) assessed by QOR-15, and sleep quality assessed by Richards Campbell Sleep Questionnaire. Tertiary outcomes include time to first flatus, gastrointestinal complications such as anastomotic leak or ileus, length of hospital stay, collapse incidence of severe cardiovascular and cerebrovascular complications of myocardial infarction, cardiac arrest, ischaemic or haemorrhagic stroke, and all-cause mortality within 30 days after the operation.

Ethics and dissemination The protocol was approved by Medical Ethics Committee of the China-Japan Union Hospital, Jilin University (Approval number: 2021081018) prior to recruitment. The study will be performed according to the guidelines of the Declaration of Helsinki. The findings of this study will be published and presented through various scientific forums.

Trial registration number ChiCTR2200055319.

  • Ischaemic heart disease
  • Gastrointestinal tumours
  • Adult anaesthesia
  • Anaesthesia in oncology
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi-org.ezproxy.u-pec.fr/10.1136/bmjopen-2022-069183

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    Strengths and limitations of this study

    • The study will conduct stellate ganglion block (SGB) after emergency from general anaesthesia.

    • This study will test the protective effect of SGB for high-risk patients who are undergoing laparoscopic radical resection for colorectal cancer.

    • This study will recruit patients from a single centre, hence further validation will be needed.

    • Patients may be aware of the randomisation thus affecting subjective outcomes of the study.

    Introduction

    Myocardial injury after non-cardiac surgery (MINS) is defined as any elevated troponin resulting from myocardial ischaemia (ie, without evidence of a non-ischaemic aetiology) which occurs during or within 30 days after non-cardiac surgery.1 2 It has been reported that MINS is associated with 30-day postoperative mortality and increased incidence of adverse cardiovascular events.3 4 Postoperative MINS may be induced by numerous risk factors, including age over 65 years, history of hypertension, diabetes and coronary artery disease, intraoperative bleeding, perioperative anaemia and pain.2 5 The aforementioned risk factors will predispose patients to MINS.1 Of note, more than 90% of MINS occurs within the initial two postoperative days.4

    Stellate ganglion block (SGB) refers to the injection of a local anaesthetic around the stellate ganglion to block the cervical sympathetic trunk, preganglionic and postganglionic fibres and their areas of innervation (head, neck, upper limb and multiple organs in the chest).6 SGB has a wide range of indications, including the management of complex regional pain syndrome (type I and II), hot flashes, sleep disturbance, angina, electric storm, long Q-T syndrome, ventricular tachycardia, diabetes, essential hypertension and postoperative cognitive dysfunction.7–10 Previous studies have shown that preoperative SGB facilitates haemodynamic stabilisation during the process of anaesthesia induction, endotracheal intubation and pneumoperitoneum, and provide the beneficial effect of myocardial injury and preventing adverse cardiovascular events in high-risk patients.11 12 Other researchers have found that SGB reduces postoperative pain, increases the local oxygen saturation, thus reducing the occurrence of postoperative cognitive dysfunction.13 In addition, studies reported that SGB can improve the quality of postoperative recovery and sleep in patients undergoing breast cancer surgery.14 Wei et al15 reported that SGB has a protective antioxidant effect during myocardial ischaemia in a rat model induced by isoproterenol. Wang et al reported that in the rabbit acute-pain model by formalin injection, SGB could effectively alleviate nociceptive responses by reducing the release of substance P and plasma catecholamine.16 However, the measured parameters in previous clinical researches, such as systolic blood pressure, diastolic blood pressure, heart rate and rate-pressure product (heart rate multiplied by systolic blood pressure), are indirect or non-specific associated with myocardial injury.

    Since studies have shown that SGB has protective effects, postoperative stress factors such as postoperative pain and sympathetic excitation may contribute to myocardial injury. But there is no research yet on the application of postoperative SGB to prevent myocardial injury caused by various postoperative stress factors. Afterwards, laparoscopic colorectal cancer surgery duration is long, and preoperative block may not last until after surgery. The preoperative block may affect intraoperative anaesthetic dosage, resulting in confounding effects. Finally, previous studies are lacking specific and sensitive indicators, such as troponin, which accurately reflect the condition of myocardial injury after SGB.

    Therefore, we propose a randomised trial to test the primary hypothesis that single-shot postoperative SGB reduces the incidence of MINS (troponin elevation) in patients undergoing laparoscopic radical resection for colorectal cancer. Secondarily, we will test the hypotheses that single-shot postoperative SGB improve pain scores, delirium, sleep quality and quality of recovery-15 (QoR-15) in patients recovering from laparoscopic radical resection of colorectal cancer.

    Methods and analysis: participants, intervention and outcomes

    Study setting

    This study will be conducted by the Department of Anesthesiology at the China-Japan Union Hospital of Jilin University. Patients with at least one risk factor and scheduled for laparoscopic radical resection for colorectal cancer will be randomised with a 1:1 allocation ratio, without stratification, to either the routine group (475 patients) or the block group (475 patients) after obtaining consent. The study schema is presented in figure 1. Experimental procedures will be performed according to the protocol as described in online supplemental table 1.

    Figure 1
    Figure 1

    Consolidated Standards of Reporting Trials flow diagram describing patient progress throughout the study.

    Eligibility criteria

    Inclusion criteria

    1. The patient is >45 years old and scheduled for elective laparoscopic radical colorectal surgery.

    2. At least one of the following risk factors: age over 65 years; history of peripheral vascular surgery; history of coronary heart disease; history of stroke or transient ischaemic attack; serum creatinine >175 µmol/L (>2.0 mg/dL); diabetes requiring medication; hypertension requiring medication; current smoker or a 15 pack-year history of smoking tobacco.

    Exclusion criteria

    1. Allergic to local anaesthetics.

    2. Infection at the puncture site.

    3. Coagulation disorder.

    4. Severe chronic obstructive pulmonary disorder, contralateral pneumonectomy, or contralateral diaphragmatic paralysis.

    5. Severe speech, vision, or auditory impairment.

    Rejection criteria: these subjects will be excluded from the analysis

    1. Consent is withdrawn by the participants before intervention is implemented. For rejected patients, detailed reasons will be recorded in the case report forms (CRF).

    2. Surgery is delayed, cancelled or surgery type changed.

    Randomisation and masking

    After consent is obtained, eligible patients will be randomised using a 1:1 ratio, without stratification to the block group or routine group. The scientific secretary will use the SAS V.9.4 software (SAS, Cary, North Carolina, USA) to generate a blocked random number sequence in permuted blocks of four participants. The system generates participant identification numbers in sequence, which will be matched with assignments at randomisation. The identification numbers and their allocation groups (block group or routine group) will be sealed in an opaque envelope by the scientific secretary who will also reveal allocation results and prepare injected drugs as either ropivacaine or normal saline after participant’s emergence from general anaesthesia.

    Intervention

    All patients will be regularly monitored using ECG, non-invasive blood pressure, pulse oxygen saturation, airway pressure, end-tidal carbon dioxide, urine output and bispectral index value. Invasive pressure will be monitored when needed. Anaesthesia induction will be performed using intravenous propofol, etomidate, sufentanil, rocuronium or cisatracurium. Intravenous propofol, remifentanil and/or sufentanil, rocuronium or cisatracurium, and inhalational sevoflurane or desflurane will be used for anaesthesia maintenance. Blood pressure will be maintained at ±20% from baseline values by infusing vasoactive agents at the discretion of attending anaesthesiologists. The bispectral index value will be maintained between 40 and 60. Mechanical ventilation will be established with a tidal volume from 6 to 8 mL/kg and adjusted to maintain the end-tidal carbon dioxide pressure between 35 to 45 mm Hg. Regional anaesthesia will be implemented according to the discretion of attending anaesthesiologists.

    Allocation will thus remain concealed until the last moment and will be revealed after emergence from general anaesthesia in the post-anaesthesia care unit. The patient will be placed in a supine position with the head turned to the left side, and a thin pillow will be placed under their shoulders to hyperextend the neck mildly. After routine sterilisation of the right neck skin, a sterilised high-frequency linear array probe (Neusoft, N1500, 6–13 MHz) will be placed to observe the cross-sectional plane of C6 or C7 transverse process nodules. The structures of the thyroid, carotid sheath, vertebral artery, inferior thyroid artery, trachea and oesophagus, prevertebral fascia, longus cervicalis and longus cephalus will be distinguished in ultrasonic image. When the tip of the needle reaches the vicinity of the stellate ganglion between the prevertebral fascia and the longus capitis muscle or longus colli, 4 mL 0.2% ropivacaine or normal saline will be injected without positive aspiration of blood and cerebrospinal fluid. A successful SGB is indicated by the signs of Horner’s syndrome. The specific manifestations are decreased pupil size (miosis), drooping eyelid (ptosis) and reducing or no sweating (anhidrosis) on the affected side of the face. We will also measure facial temperature and index finger perfusion index to help determine whether the block is successful. One experienced anaesthesiologist who performs SGB will not be involved in intraoperative anaesthesia and will be referred to as the operator. Horner’s syndrome will be judged by the same operator.

    Blinding

    Investigators, intraoperative attending surgeons and anaesthesiologist will be blinded to the group allocation. In addition, the operator who performs SGB will also be blinded because the drug was fully transparent and was dispensed by the scientific secretary who generated the randomised results. Participated patients may be aware of the assignment because of Horner’s syndrome.

    Data collection

    The required data will be collected by trained research staff under the instruction of the participant timeline displayed in online supplemental table 1, recorded in paper-based CRFs and then stored as Excel digital forms. Investigators will conduct the follow-up in person or make phone calls to improve adherence to intervention protocols.

    Baseline characteristics

    After signing the informed consent form, baseline blood pressure and sleep quality assessed with Richards Campbell Sleep Questionnaire (RCSQ) will be recorded on the CRF by blinded research staff in at least 1 day before surgery. Then they will document patients’ demographics, anaesthesia details and surgical information on the CRF on the day of the surgery. Demographic data will include age, gender, body mass index, and American Society of Anesthesiologists physical status.

    Intraoperative and postoperative measurements

    Surgical information including the surgical site (colon, rectal or both), details of the surgery and the presence or absence of colostomy will be recorded. Horner’s syndrome will be recorded by the scientific secretary. Preoperative, intraoperative and postoperative analgesics will also be recorded based on the medical records.

    Primary outcome

    The primary outcome will be the incidence of MINS, defined as elevated postoperative troponin levels as a result of myocardial ischaemia (ie, no evidence of a non-ischaemic aetiology), during or within 30 days after non-cardiac surgery and without the required presence of an ischaemic feature (eg, symptoms of ischaemia or electrocardiography finding).2 MINS will be diagnosed by troponin I levels exceeding the individual site threshold of 0.04 ng/mL, apparently of ischaemic origin (eg, no other apparent cause for artifactual elevation). MINS will be considered positive for patients with abnormal baseline troponin values if there is a ≥20% rise in troponin I after non-cardiac surgery.17 Serum troponin I levels will be monitored preoperatively and during the first two postoperative days because more than 90% of MINS have been reported to occur within the first two postoperative days. There is no preference for troponin T over troponin I.2 4 Abnormal troponin concentrations will be evaluated as clinically indicated with ECG, echocardiography and clinical symptoms; the resulting values will be recorded, as will other cardiovascular interventions such as angioplasty.

    Secondary outcome

    1. Pain scores: using the Visual Analogue Scale at rest and movement will be evaluated using a questionnaire twice in the first 3 days after surgery at 08:00 and 17:00 hours. The scale is mainly composed of a 100 mm straight line, one end of which indicates no pain, and the other end indicates the most severe pain or extreme pain. Patients will be asked to mark the corresponding position on this line to represent the intensity of pain they experience at that time.

    2. Delirium: Evaluation will be performed twice daily in the first 3 days after surgery at 08:00 and 17:00 hours. The Chinese version of three-dimensional Confusion Assessment Method proved to be easy and convenient and can be used as an assessment tool to assess delirium in elderly surgical patients.18

    3. QOR-15: Scale assessment will be performed on the third postoperative day in person or by phone for discharged patients. The QOR-15 is a patient-reported outcome questionnaire that measures the QOR after surgery and anaesthesia.19 A Chinese version of the QOR instrument has been validated.20

    4. RCSQ: Sleep quality will be assessed using RCSQ at 08:00 hours on the first day after surgery. The RCSQ is a five-item Visual Analogue Scale, including sleep depth, difficulty falling asleep, number of awakenings, difficulty of falling asleep again and overall sleep quality. During measurement, the patient selects the position on a straight line representing the sleep quality the previous night. The left end of the line is 0, and the right is 100, indicating poor sleep and good sleep, respectively. Researchers will then measure the distance from the cross point to the right end of the straight line with a ruler to mark the patient’s score. Patients’ RCSQ sleep score will be an average score of the five items, with higher scores indicating better sleep.21

    Tertiary outcome

    1. Time to first flatus: Follow-up will be conducted twice daily in the first 3 days after surgery, at 08:00 and 17:00 hours until corresponding results are recorded (hours). The result of more than 3 days is calculated as the actual number of days multiplied by 24 hours.

    2. Gastrointestinal complications: Intestinal obstruction and anastomotic fistula. These items will be obtained from the medical record.

    3. Postoperative hospital stay: This information will be retrieved from the medical record.

    4. Other complications: Collapsed composite incidence of serious cardiovascular and cerebrovascular complications of myocardial infarction, non-fatal cardiac arrest, ischaemic or haemorrhagic stroke and all-cause mortality 30 days after the operation. Myocardial infarction will be diagnosed in the conditions of both MINS and at least one symptom (eg, chest pain or shortness of breath) or sign (eg, ECG or echocardiogram abnormality) are present. Strokes will be detected from clinical symptoms lasting at least 24 hours, and require imaging evidence consistent with new-onset cerebral ischaemic or haemorrhagic injury. The information will be obtained on postoperative 30-day follow-up through the phone.

    Safety outcomes

    Adverse events in clinical trials are undesired medical events that occur after a clinical trial subject receives a testing medical product or intervention but are not necessarily clarified causal effects with the intervention treatment of the study. Adverse events include (but are not limited to) hypotension (systolic blood pressure <90 mm Hg or a decrease of more than 30% from baseline), bradycardia (heart rate <50 beats per minute), hoarseness which is transient and secondary to inadvertent recurrent laryngeal nerve blockade,22 neck hematoma, local anaesthetic systemic toxicity, light-headedness, hypertension and numbness of forearm or fingers.23 All participants will be monitored for half an hour after administering SGB.

    Detailed information about adverse events will be recorded, including the time-point of the event, therapeutic course, outcomes and follow-up. All the clinical documents associated with adverse events will be identified, reserved and sent to the project manager and the ethics committee within the requested time range.

    Data and sample storage

    All the clinical trial materials will be reserved uniformly by the scientific secretary for at least 5 years after termination of the study. After measurement, biological samples will be destroyed at the China Japan Union Hospital, Department of Laboratory Medicine. Two independent researchers will add all information to Excel forms on a password-protected computer. The investigators and statistician who were involved in the study have access to the final data set.

    Data monitoring

    We will perform interim analyses at each 25% of the maximum enrolment. Efficacy and futility boundaries are defined in figure 2. Due to the low-risk nature of the intervention, the Data Monitoring Committee is not deemed necessary in our study.

    Figure 2
    Figure 2

    Efficacy and futility boundaries of the interim analysis.

    Protocol changes

    Any important protocol changes will be communicated to relevant parties (ie, Medical Ethics Committee of China-Japan Union Hospital, Chinese Clinical Trials Registry, journals, and researchers).

    Sample size calculation

    A previous study found that the incidence of MINS was about 10%.24 25 This trial is designed to have 80% power at the 0.05 significance level to detect a relative risk of 0.50 or lower for the block versus the routine group. Adjusting for three interim analyses, this trial will require a maximum of 914 patients. Considering the loss to follow-up and withdrawal of patients, we plan to randomise 950 patients. The sample size calculation was performed using PASS and SAS software.

    Statistical analysis

    The analysis will be performed with modified intent-to-treat, where all randomised patients who received treatment will be included in the analysis. And we will perform a per-protocol analysis on the primary outcome. Patients assigned to the treatment and the control group will be compared on their demographics and baseline variables using absolute standardised differences. Any variables with an absolute standardised difference >0.10 Embedded Image will be regarded as imbalanced and adjusted for in the subsequent analysis.

    For the primary outcome, the incidence of MINS will be compared using the χ2 test (or logistic regression models if any baseline variables are not balanced). For secondary and tertiary outcomes, continuous outcomes will be summarised as mean±SD if normally distributed or as median if skewed. Continuous outcomes will be compared through t-tests with the appropriate transformation of the outcome variables if needed. As appropriate, categorical variables will be presented as the number of subjects (percentage) and compared using the χ2 test or Fisher’s exact test. Serially measured variables will be compared using a linear mixed model, including time and treatment assignment, with a random intercept for each patient and an autocorrelation (AR1) correlation structure. Time – treatment interaction will be included if significant. The Bonferroni correction will be applied to secondary outcomes to control for overall type I errors.

    Mixed effect model can handle missing values in longitudinal data. Imputation is not recommended here. And we will perform interim analyses at each 25% of the maximum enrolment.

    Patient and public involvement

    There was no patient involved in designing the study.

    Ethics and dissemination

    The protocol was approved by the Medical Ethics Committee of the China-Japan Union Hospital, Jilin University (Approval number: 2021081018) prior to recruitment. The study will be performed according to the guidelines of the Declaration of Helsinki. The findings of this study will be published and presented through various scientific forums.

    Discussion

    SGB has become a treatment for pain and other diseases with a wide range of indications and definite efficacy. This study aimed to explore the effect of right SGB (RSGB) on postoperative myocardial injury in high-risk patients undergoing elective laparoscopic colorectal cancer surgery. Zhao26 27 suggested that RSGB reduced sympathetic neuronal stimulation and increased parasympathetic nervous excitation. Furthermore, Koyama et al28 showed that RSGB suppresses cardiac sympathetic function without significantly affecting blood pressure and thus may be a safe and effective therapy for chronic pain syndrome. Therefore, each participant in this study will be injected around the right-side stellate ganglion.

    The concentration and volume of ropivacaine are based on a previous study investigating the dose-response relationship between ropivacaine and SGB, which found that Effective Dose 95 (ED95) of 0.2% ropivacaine for SGB was 3.2 mL (95% CI 2.8~4.1 mL).29 To guarantee a 100% block effect, we chose a relatively larger but safe dose range of 4 mL 0.2% ropivacaine. The stellate ganglion is one of the cervical sympathetic ganglia. Cervical sympathetic ganglia give off postganglionic fibres forming the cardiac branches that supply the heart. Previous studies have found that SGB could have antioxidative effects against acute myocardial ischaemia.15 Moreover, clinical studies have found that SGB reduces the haemodynamic fluctuations during endotracheal intubation and carbon dioxide pneumoperitoneum and has a protective effect on myocardial injury.11 12 15

    Gupta et al30 suggest that SGB decreases cerebral vascular tone without affecting the capacity of autoregulation of vessels. In addition, some researches believe that SGB can increase the local oxygen saturation of the blocked side, thereby reducing the occurrence of postoperative cognitive dysfunction,13 but recent studies have shown that local brain oxygen saturation is not significantly related to the occurrence of postoperative cognitive dysfunction; hence, this mechanism is still controversial.31 Therefore, we want to explore the relationship between SGB and postoperative delirium.

    Postoperative sleep disorders will increase due to incision pain or noisy environments. However, Lipov et al32 suggested that SGB could provide breast cancer survivors with relief from sleep dysfunction with few or no side effects. Therefore, our study will explore the effect of SGB in patients undergoing colorectal surgery.

    This protocol has some limitations. First, patients can be affected by the presence of Horner’s sign and not blinded to the randomisation. Second, the delirium assessment time is the first three postoperative days, which may not be enough.

    With the introduction of enhanced recovery after surgery, clinicians are required to improve the physiology and psychology of patients during the perioperative period. Therefore, we will explore the effect of postoperative SGB on the quality of postoperative recovery in high-risk patients, thus exploring perioperative management strategies that are more conducive for patients.

    Ethics statements

    Patient consent for publication

    Acknowledgments

    We sincerely thank all colleagues and the participants in this study.

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    Supplementary materials

    • Supplementary Data

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    Footnotes

    • Contributors ZH: This author helped with study design, and writing the manuscript and read and approved the final version of the manuscript. WL: This author helped with interpretation and writing the manuscript, and read and approved the final version of the manuscript. GZ: This author helped with writing the manuscript, and read and approved the final version of the manuscript. CL: This author helped with writing the manuscript, and read and approved the final version of the manuscript. KL: This author helped with study design and writing the manuscript, and read and approved the final version of the manuscript.

    • Funding The trial is sponsored by Jilin Province Department of Finance (grant number: 2021-SCZ-41).

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.