Opioid Sparing Effect of an ISP Nerve Block on Post-Op Pain Control in Posterior Cervical Spine Surgery

Part of paid clinical trials in Stony Brook, New York.

Sponsor
Stony Brook University
Study ID
NCT06570577
Status
Recruiting
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Conditions

  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Inter-semispinalis Plane Block — PROCEDURE
    A nerve block targeting the dorsal rami of the cervical spinal nerves can help alleviate postoperative incisional pain.
  • Opioids — DRUG
    Routine Pain Management

Study Details

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.

Key Dates

Start date
Feb 21, 2025
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Lower opioid use [ Time Frame: 48 hours post Post-Anaesthesia Care Unit (PACU) arrival time ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stony Brook University HospitalStony BrookNew York11794
Eman Nada, MBBCH
[email protected]
516-287-9118
Eman Nada, MBBCH (PRINCIPAL_INVESTIGATOR)

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By research site
Stony Brook University Hospital· Stony Brook, NY

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