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

NCT06570577 | Recruiting

• 1 other identifier: IRB2024-00227
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

cervical fusion; opioids

Outcome Measures

Primary Outcomes (1)

• Lower opioid use

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

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

Secondary Outcomes (4)

• Lower opioid use.

  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.

• Lower opioid use

  24 hours after PACU arrival time

• Pain Scores

  48 hours after PACU arrival time

• Length of hospital stay

  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.

Study Arms (2)

Routine Pain Management

ACTIVE COMPARATOR

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.

Drug: Opioids

Routine Pain Management plus an Inter-semispinalis Plane Block

EXPERIMENTAL

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.

Procedure: Inter-semispinalis Plane Block

Interventions

Inter-semispinalis Plane Block PROCEDURE

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

Also known as: ISP nerve block

Routine Pain Management plus an Inter-semispinalis Plane Block

Opioids DRUG

Routine Pain Management

Also known as: Pharmacologic pain management

Routine Pain Management

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Klippel-Feil Syndrome

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Eman Nada, MBBCH

  Stony Brook University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Nada, MBBCH

CONTACT

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

Darcy Halper, B.S.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomized using REDCap software. If the participant is randomized to the ISP Block group, it will be completed after the participant has been administered General Anesthesia and prior to surgery start.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Regional Anesthesia

Model Details: This is a randomized, blinded, 2-arm study of 60 participants. Two groups of 30 patients will be randomized to either 1) Routine pain management or 2) Inter-semispinalis Plane (ISP) Block plus Routine Pain Management.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 26, 2024
• Study Start: February 21, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)