Actively Recruiting

Phase 4
Age: 40Years - 80Years
All Genders
NCT05996133

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

Led by Hartford Hospital · Updated on 2025-09-05

38

Participants Needed

1

Research Sites

185 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 40 to 80 years, any gender, race, and ethnicity
  • Scheduled for elective primary posterior cervical spine fusion surgery by study surgeons
  • Able to speak and read English
  • Have American Society of Anesthesiology (ASA) physical status score I to IV
Not Eligible

You will not qualify if you...

  • Emergency posterior cervical spine fusion surgery
  • Revision surgery or previous cervical spine surgery
  • Allergy to local anesthetics or steroids
  • Coagulopathy at the time of surgery
  • Contraindications to MCP blocks, including anatomical abnormalities or previous surgeries preventing block
  • Infection at the site of block
  • Weight less than 40 kg
  • Chronic or continuous opioid use over 50 morphine milligram equivalents per day for at least 30 days within 90 days before surgery
  • History of chronic inflammatory conditions such as multiple sclerosis
  • Refusal to participate or not providing study consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hartford Hospital

Hartford, Connecticut, United States, 06102

Actively Recruiting

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Research Team

A

Aseel Walker, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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