Recruiting

Nerve Block

Sponsor:

Stony Brook University

Code:

NCT06570577

Conditions

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Inter-semispinalis Plane Block

Opioids

Study Details

Brief 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.

Conditions

Pain, Postoperative

Study ID

NCT06570577

Start date

Feb 21, 2025

Status verified date

Apr, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Fusion and decompression due to trauma
  • Emergent procedures
  • Patient is on a medication-assisted treatment, e.g., buprenorphine, naltrexone or methadone.
  • There is an infection near or in the area of neck where the block will be placed.
  • The patient is having a complicated surgery or a revision surgery
  • Female patient with a positive pregnancy test on the day of surgery (hospital standard-of-care).
  • Patient has Diabetes
  • Patients who have had a prior adverse reaction to bupivacaine or dexamethasone
  • Patients with Glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Inter-semispinalis Plane Block

A nerve block targeting the dorsal rami of the cervical spinal nerves can help alleviate postoperative incisional pain.

Opioids

Routine Pain Management

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Eman Nada, MBBCH

516-287-9118Eman.Nada@stonybrookmedicine.edu

Darcy Halper, B.S.

631-444-2970Darcy.Halper@stonybrookmedicine.edu

Locations

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Eman Nada, MBBCH

516-287-9118Eman.Nada@stonybrookmedicine.edu

Principal Investigator:

Eman Nada, MBBCH

More Information

Sponsor

Stony Brook University

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • cervical fusion
  • opioids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2026-04-29.