The Opioid Sparing Effect of an Inter-semispinalis Plane Block on Postoperative Pain Control in Posterior Cervical Spine Surgery

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Participants who have a surgical procedure called Posterior Cervical (neck) Spine Surgery will normally need pain medication to relieve post operative pain. This usually includes opioid medications. In this study, the consented participant may receive a nerve block procedure, in addition to the pain relieving medication. There is a fifty-fifty chance to receive the nerve block. The goal is to see if the nerve block group needs less opioid medication, has lower pain scores and is discharged from the hospital sooner.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• Having Posterior Cervical Spine Surgery from C2 - C7, which may extend to the upper thoracic vertebrae, inclusive to T3.

• Capacity to provide informed consent

Locations
United States
New York
Stony Brook University Hospital
RECRUITING
Stony Brook
Contact Information
Primary
Eman Nada, MBBCH
Eman.Nada@stonybrookmedicine.edu
516-287-9118
Backup
Darcy Halper, B.S.
Darcy.Halper@stonybrookmedicine.edu
631-444-2970
Time Frame
Start Date: 2025-02-21
Estimated Completion Date: 2026-02
Participants
Target number of participants: 60
Treatments
Active_comparator: Routine Pain Management
Routine Pain Management will include standard of care pharmacological management, by using patient-controlled opioid analgesia, oral acetaminophen, intravenous Ketorolac (Toradol), and Gabapentin. As needed (PRN), Intravenous hydromorphone will be given for breakthrough pain.
Experimental: Routine Pain Management plus an Inter-semispinalis Plane Block
Routine Pain Management, as described above, plus and ISP Block. After general anesthesia has begun, in the operating room, and the patient is moved to the prone position, before surgery start, those patients who are randomized to the block group, will receive a bilateral ISP nerve block in the back of the neck under ultrasound guidance, by a qualified, experienced Anesthesiologist.~Under complete aseptic technique using an ultrasound guidance, 20 ml of Bupivacaine 0.25 % with 2 mg of Dexamethasone will be injected between two muscles in the back of the neck, bilaterally, to block the nerves that run in this plane.~Once the block is completed, the surgical procedure will proceed as usual.
Related Therapeutic Areas
Sponsors
Leads: Stony Brook University

This content was sourced from clinicaltrials.gov