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

NCT ID: NCT06570577

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-21
• Study Completion Date: 2026-02-28

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.

Detailed 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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Opioids

Intervention Type: DRUG

Routine Pain Management

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.

Group Type: EXPERIMENTAL

Inter-semispinalis Plane Block

Intervention Type: PROCEDURE

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

Interventions

Inter-semispinalis Plane Block

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

Intervention Type: PROCEDURE

Opioids

Routine Pain Management

Intervention Type: DRUG

Other Intervention Names

ISP nerve block; Pharmacologic pain management

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Eman Nada

Chief of Regional Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman Nada, MBBCH

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University Hospital

Locations

Stony Brook University Hospital

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Eman Nada, MBBCH

Role: CONTACT

Eman.Nada@stonybrookmedicine.edu

516-287-9118

Darcy Halper, B.S.

Role: CONTACT

Darcy.Halper@stonybrookmedicine.edu

631-444-2970

Facility Contacts

Eman Nada, MBBCH

Role: primary

Eman.Nada@stonybrookmedicine.edu

516-287-9118

Other Identifiers

IRB2024-00227

Identifier Type: -

Identifier Source: org_study_id