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

Hartford Hospital

Status and phase: Enrolling; Phase 4

Conditions: Cervical Spine Fusion

Treatments: Drug: Bupivacaine Hcl 0.25% Inj; Other: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05996133

HHC-2023-0156

Details and patient eligibility

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

MCP Block

Experimental group

Description:

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.

Treatment:

Drug: Bupivacaine Hcl 0.25% Inj

Sham Block

Sham Comparator group

Description:

Bilateral sham block using 3 mL of normal saline injections subcutaneously on the neck.

Treatment:

Other: Normal saline