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NCT Number: NCT06570577

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location status: Recruiting

Location contact

Eman Nada, MBBCH

CONTACT

[email protected]

516-287-9118

Eman Nada, MBBCH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inter-semispinalis Plane Block

Procedure

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

Other names: ISP nerve block

Opioids

Drug

Routine Pain Management

Other names: Pharmacologic pain management

Primary outcomes

  1. Lower opioid use

    Time frame: 48 hours post Post-Anaesthesia Care Unit (PACU) arrival time

    Comparison of the reduction in Morphine Milligram Equivalent (MME) dose of opioids consumed between the control group versus the nerve block group.

Secondary outcomes

  1. Lower opioid use.

    Time frame: MME use will be recorded from the patient's Anesthesia induction time until the patient's PACU arrival time. This will be the intra-operative period, which may last several hours, but not expected to exceed eight hours.

    MME from anesthesia induction time until PACU arrival time.

  2. Lower opioid use

    Time frame: 24 hours after PACU arrival time

    MME for the 24 hours after PACU arrival time

  3. Pain Scores

    Time frame: 48 hours after PACU arrival time

    Using a Numeric Rating Scale (NRS), pain scores will be obtained at specified times and then compared between the two groups. Participants will be asked to rate their pain on a scale from 0 - 10, where zero represents 'no pain at all' and 10 represents 'the worst pain ever possible'.

  4. Length of hospital stay

    Time frame: The patient's EMR will record the date and time of admission, as well as, the date and time of discharge. This will be quantified by the REDCap software being used for this study, and is not expected to exceed four days.

    The length of hospital stay will be compared between the two groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Darcy Halper, B.S.

CONTACT

[email protected]

631-444-2970

Eman Nada, MBBCH

CONTACT

[email protected]

516-287-9118

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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