Multifidus Cervicis Plane Block Vs. Sham Block For Posterior Cervical Spine Fusion Surgery

Study Overview
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Brief Summary
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The goal of this randomized, double-blinded, clinical trial is to assess the benefit of administering a Multifidus Cervicis Plane (MCP) block compared to a sham block as a method of postoperative pain control in patients undergoing posterior cervical spine fusion surgery. The main question it aims to answer is if the MCP block group will have reduced maximum pain scores during the first 24 postoperative hours compared to the sham block group. Participants will receive preoperative bilateral MCP blocks on the back of their neck using the standard of care local anesthetic solution that consists of 30 mLs 0.25% Bupivacaine + 0.5 mL (5 mg) preservative-free Dexamethasone + 0.1 mL Epinephrine (MCP block group). Researchers will compare the MCP block to the preoperative sham block which consists of injecting 3 mL of normal saline into the same area (Sham block group) to compare the postoperative pain scores between the groups as a main objective. The secondary objectives are: Postoperative opioid consumption during hospitalization and at 2 weeks after discharge. The amount and type of non-opioid analgesics used during hospitalization. The occurrence of postoperative nausea and vomiting (PONV) and the use of antiemetics. Hospital and Post Anesthesia Care Unit length of stay (LOS). Monitor the safety of the study interventions during hospitalization and readmissions within 30 days of discharge. Patient satisfaction with pain management and overall satisfaction with the surgery experience.

Official Title
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MCP Study, A Double-Blinded, Randomized Controlled Trial To Compare Multifidus Cervicis Plane Block (MCP) Vs. Sham Block, In Reducing Postoperative Pain And Opioid Consumption In Patients Undergoing Elective Primary Posterior Cervical Spine Fusion Surgery (CSFS)

Conditions
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Cervical Spine Fusion

Intervention / Treatment
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* Drug: Bupivacain
* Drug: Dexamethasone
* Drug: Epinephrine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 40-80 years old, males and females, of any race and any ethnic group. Patients are scheduled for elective primary posterior cervical spine fusion surgery (CSFS) to be performed by one of the spine surgeons in the study. Ability to speak and read English Patients with American Society of Anesthesiology (ASA) physical status score I- IV Exclusion Criteria: Emergency posterior CSFS. Revision surgery or history of previous cervical spine surgery History of allergy to local anesthetics or steroids. Patients who are coagulopathic at the time of surgery Patients with contraindications to MCP blocks, including but not limited to anatomical abnormality or previous surgical intervention that limits or prevents receiving the blocks Infection at the site of the block. Weight < 40 kg to avoid local anesthetic toxicity. Patients on chronic or continuous opioid use of > 50 MME (morphine milli-equivalent) per day for at least 30 days within 90 days prior to surgery. Patients with a history of chronic inflammatory conditions such as multiple sclerosis Refusal to participate or lack of providing the study consent

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center, prospective, double-blinded, randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCP Block<br>Bilateral Multifidus Cervicis plane block using 30 mL of 0.25% bupivacaine + 0.5 mL (5 mg) preservative-free dexamethasone + 0.1 mL epinephrine 1:400,000. | Drug: Bupivacain<br>* 30 mL of 0.25% bupivacaine<br>* Other names: Marcaine;Drug: Dexamethasone<br>* 0.5 mL (5 mg) preservative-free dexamethasone<br>Drug: Epinephrine<br>* 0.1 mL epinephrine 1:400,000.<br>* Other names: Adrenaline;|
| Sham Comparator: Sham Block<br>Bilateral sham block using 3 mL of normal saline injections subcutaneously on the neck. | Drug: Normal saline<br>* 3 mL normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum postoperative pain score | The maximum pain score for the past 24 postoperative hours, on a scale from 0-10 where 0 is no pain and 10 is severe pain reported by participants using the validated tool; Brief Pain Inventory-Short Form. | Up to 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum, average, minimum, and current pain scores | The maximum, average, minimum, and current pain scores for the past 24 hours, on a scale from 0-10 where 0 is no pain and 10 is severe pain, reported by participants daily and up to 72 postoperative hours and at 2 weeks after discharge using the validated tool; Brief Pain Inventory-Short Form. | 0-24 hours; 24-48 hours; 48-72 hours and at 2 weeks (+/- 7 days) after discharge via a phone call. | 
| Total opioid consumption | The total intraoperative and postoperative opioid consumption will be measured in morphine MilliEquivalent (MME) during hospitalization on the 6th, 12th, 24th, 48th, and 72nd postoperative hours, and at 2 weeks (+/- 7 days) after discharge via a phone call using a question asking if the patient is still using opioids (yes/no) | at 6th, 12th, 24th, 48th, and 72nd postoperative hours, and at 2 weeks (+/- 7 days) after discharge. | 
| Non- opioid analgesics use | The number of non-opioid analgesics used (frequency), including NSAIDs, muscle relaxants, and gabapentin at any time throughout hospitalization up to 72 hours postoperatively. | Up to 72 hours postoperative | 
| Postoperative nausea/vomiting scores | Postoperative nausea/vomiting scores will be collected using the Simplified Postoperative Nausea and Vomiting Impact Scale, a validated measure that consists of two questions, each with a possible response score of 0-3. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting. | Daily at 24th, 48th, and 72th postoperative hours | 
| Hospital and Post Anesthesia Care Unit length of stay | Hospital and PACU length of stay will be calculated in hours from the date and time of admission and discharge from the electronic medical records. | Up to 72 postoperative hours | 
| The occurrence of block complications | The occurrence of block complications will be collected during hospitalization will be assessed daily for up to the discharge from the hospital. | Up to 72 postoperative hours | 
| Participant satisfaction with the pain management service and the overall surgery experience | Using the Customer Satisfaction Score (CSAT) tool, prior to discharge and at 2 weeks (+/- 7 days) after discharge via a phone call by the ARC. By asking participants to rate their satisfaction with pain management service and the overall surgery experience on a five-point scale: 1- very unsatisfied; 2- Unsatisfied; 3- Neutral; 4- Satisfied; and 5- Very satisfied. The metric will be looking specifically at the percentage of happy patients. The CSAT percentage score is calculated by looking at the 4 to 5 ratings. The formula is: (The total Number of 4 and 5 responses) ÷ (Number of total responses) x 100 = % of satisfied patients, a score of 80% will be considered 'good'. | at 72nd postoperative hour and at 2 weeks (+/- 7 days) after discharge via a phone call | 
| Antiemetics used | The number of doses (frequency) of intra and postoperative antiemetics will be collected up to 72 postop hours. | up to 72 postoperative hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posterior cervical spine fusion surgery, Multifidus Cervicis Plane Block