Comparing pain relief methods after cervical spine surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a Multifidus Cervicis Plane (MCP) block in reducing postoperative pain compared to a sham block in patients undergoing posterior cervical spine fusion surgery. Participants will receive either the MCP block, which includes a local anesthetic and steroid, or a placebo saline injection before their surgery. The primary outcome is to measure maximum pain scores during the first 24 hours after surgery. This randomized, double-blinded approach ensures that neither the participants nor the researchers know which treatment is being administered, enhancing the reliability of the results.

Why it matters

Who can join: the full rules

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

Where it's running

• Hartford Hospital
  Hartford, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Pranjali Kainkaryam, MD — Hartford Hospital
• Study coordinator: Aseel Walker, MD
• Email: aseel.walker@hhchealth.org
• Phone: (860) 972-1778

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.