Recruiting

Multifidus Cervicis Plane Block vs. Sham Block

Sponsor:

Hartford Hospital

Code:

NCT05996133

Conditions

Cervical Spine Fusion

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine Hcl 0.25% Inj

Normal saline

Study Details

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.

Conditions

Cervical Spine Fusion

Study ID

NCT05996133

Start date

Dec 12, 2023

Status verified date

Aug, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

38 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Normal saline

3 mL normal saline

Primary outcome measure

  • The maximum postoperative pain score [ Time Frame: Up to 24 hours after surgery ]

Central Contacts and Locations

Central contacts

Aseel Walker, MD

(860) 972-1778aseel.walker@hhchealth.org

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Pranjali Kainkaryam, MD

860-972-2117Pranjali.Kainkaryam@HHCHealth.org

Aseel Walker, MD

860-972-1778aseel.walker@hhchealth.org

More Information

Sponsor

Hartford Hospital

Last update posted

Sep 5, 2025

Last verified

Aug, 2025

Keywords

  • Posterior cervical spine fusion surgery
  • Multifidus Cervicis Plane Block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2025-09-05.