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

Phase 4

Recruiting

• Conditions: Cervical Spine Fusion
• Interventions: Drug: Normal saline; Drug: Bupivacain; Drug: Dexamethasone; Drug: Epinephrine

• Registration Number: NCT05996133
• Lead Sponsor: Hartford Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-16
• Status Verified: 2023-12
• Study Start: 2023-12-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-19
• Primary Completion: 2024-12-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Patients 40-80 years old, males and females, of any race and any ethnic group.
2. Patients are scheduled for elective primary posterior cervical spine fusion surgery (CSFS) to be performed by one of the spine surgeons in the study.
3. Ability to speak and read English
4. Patients with American Society of Anesthesiology (ASA) physical status score I- IV

Exclusion Criteria

1. Emergency posterior CSFS.
2. Revision surgery or history of previous cervical spine surgery
3. History of allergy to local anesthetics or steroids.
4. Patients who are coagulopathic at the time of surgery
5. Patients with contraindications to MCP blocks, including but not limited to anatomical abnormality or previous surgical intervention that limits or prevents receiving the blocks
6. Infection at the site of the block.
7. Weight < 40 kg to avoid local anesthetic toxicity.
8. 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.
9. Patients with a history of chronic inflammatory conditions such as multiple sclerosis
10. Refusal to participate or lack of providing the study consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MCP Block	Epinephrine	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.
Sham Block	Normal saline	Bilateral sham block using 3 mL of normal saline injections subcutaneously on the neck.
MCP Block	Bupivacain	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.
MCP Block	Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
The maximum postoperative pain score	Up to 24 hours after surgery	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.

Secondary Outcome Measures

Name	Time	Method
The maximum, average, minimum, and current pain scores	0-24 hours; 24-48 hours; 48-72 hours and at 2 weeks (+/- 7 days) after discharge via a phone call.	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.
Total opioid consumption	at 6th, 12th, 24th, 48th, and 72nd postoperative hours, and at 2 weeks (+/- 7 days) after discharge.	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)
Non- opioid analgesics use	Up to 72 hours postoperative	The number of non-opioid analgesics used (frequency), including NSAIDs, muscle relaxants, and gabapentin at any time throughout hospitalization up to 72 hours postoperatively.
Postoperative nausea/vomiting scores	Daily at 24th, 48th, and 72th postoperative hours	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.
Hospital and Post Anesthesia Care Unit length of stay	Up to 72 postoperative hours	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.
The occurrence of block complications	Up to 72 postoperative hours	The occurrence of block complications will be collected during hospitalization will be assessed daily for up to the discharge from the hospital.
Antiemetics used	up to 72 postoperative hours	The number of doses (frequency) of intra and postoperative antiemetics will be collected up to 72 postop hours.
Participant satisfaction with the pain management service and the overall surgery experience	at 72nd postoperative hour and at 2 weeks (+/- 7 days) after discharge via a phone call	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'.

Trial Locations

Locations (1)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States