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

NCT05996133 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-09-05

No results posted yet for this study

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.

Conditions

  • Cervical Spine Fusion

Interventions

DRUG

Bupivacaine Hcl 0.25% Inj

30 mL of 0.25% bupivacaine + 0.5 mL (5 mg) preservative-free dexamethasone + 0.1 mL epinephrine 1:400,000.

OTHER

Normal saline

3 mL normal saline

Sponsors & Collaborators

  • Hartford Hospital

    lead OTHER

Principal Investigators

  • Pranjali Kainkaryam, MD · Hartford Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2026-12-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05996133 on ClinicalTrials.gov