Comparing Multifidus Cervicis Plane Block Vs. Sham Block, In Reducing Postoperative Pain And Opioid Consumption In Patients Undergoing Elective Primary Posterior Cervical Spine Fusion Surgery

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
Hartford Hospital
RECRUITING
Hartford
Contact Information
Primary
Aseel Walker, MD
aseel.walker@hhchealth.org
(860) 972-1778
Time Frame
Start Date: 2023-12-12
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 38
Treatments
Experimental: MCP Block
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_comparator: Sham Block
Bilateral sham block using 3 mL of normal saline injections subcutaneously on the neck.
Related Therapeutic Areas
Sponsors
Leads: Hartford Hospital

This content was sourced from clinicaltrials.gov

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