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

Last updated: March 13, 2025
Sponsor: Stony Brook University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Opioids

Inter-semispinalis Plane Block

Clinical Study ID

NCT06570577
IRB2024-00227
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

  • Capacity to provide informed consent

Exclusion

Exclusion Criteria:

  • Fusion and decompression due to trauma

  • Emergent procedures

  • Patient is on a medication-assisted treatment, e.g., buprenorphine, naltrexone ormethadone.

  • 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 (hospitalstandard-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 oridiopathic methemoglobinemia

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Opioids
Phase:
Study Start date:
February 21, 2025
Estimated Completion Date:
February 28, 2026

Study Description

The purpose of this research study is to evaluate the opioid-sparing effect of the use of an Inter-semispinalis plane (ISP) block after posterior cervical spine surgery.

Posterior cervical fusion (PCF) is a painful procedure that often requires the use of high doses of opioids to minimize postoperative pain. Uncontrolled pain can result in a delay in recovery and discharge. Additionally, high doses of opioids carry the risk of opioid dependence, and other side effects, include nausea, vomiting, sedation, and, in rare cases, respiratory depression. For all of the above reasons, reducing the use of opioids is of utmost importance.

Nerve blocks are one alternative to opioid use. The ISP block is a procedure described in 2017; it is a relatively simple procedure that entails injecting local anesthetic between two muscles in the back of the neck, bilaterally, to block the nerves that run in this plane. It is done under ultrasound guidance and, although a limited number of studies have shown promise, more data on its safety and efficacy are needed. The addition of Dexamethasone to local anesthetics, in nerve blocks, resulted in significant prolongation of the analgesia.

Connect with a study center

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Active - Recruiting

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