Comparing pain relief methods after cervical spine surgery
Comparing Multifidus Cervicis Plane Block Vs. Sham Block, In Reducing Postoperative Pain And Opioid Consumption In Patients Undergoing Elective Primary Posterior Cervical Spine Fusion Surgery
This study is testing if a special pain relief injection can help people feel less pain after cervical spine surgery compared to a fake injection.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Hartford Hospital Academic / other |
| Locations | 1 site (Hartford, Connecticut) |
| Trial ID | NCT05996133 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-80 scheduled for elective primary posterior cervical spine fusion surgery.
Not a fit: Patients undergoing emergency surgery, revision surgery, or those with contraindications to MCP blocks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective pain management option for patients recovering from cervical spine surgery.
How similar studies have performed: Previous studies have shown promising results with similar regional anesthesia techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hartford, Connecticut
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.