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

The Opioid Sparing Effect of an Inter-semispinalis Plane Block on Postoperative 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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Opioids; Procedure: Inter-semispinalis Plane Block

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eman Nada, MBBCH; Phone Number: 516-287-9118; Email: Eman.Nada@stonybrookmedicine.edu
• Study Contact Backup: Name: Darcy Halper, B.S.; Phone Number: 631-444-2970; Email: Darcy.Halper@stonybrookmedicine.edu

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Hospital
      • Contact: Eman Nada, MBBCH; Phone Number: 516-287-9118; Email: Eman.Nada@stonybrookmedicine.edu
      • Principal Investigator: Eman Nada, MBBCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Opioids; Routine Pain Management; Other Names: Pharmacologic pain management
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.	Procedure: Inter-semispinalis Plane Block; A nerve block targeting the dorsal rami of the cervical spinal nerves can help alleviate postoperative incisional pain.; Other Names: ISP nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower opioid use.	MME from anesthesia induction time until PACU arrival time.	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	MME for the 24 hours after PACU arrival time	24 hours after PACU arrival time
Length of hospital stay	The length of hospital stay will be compared between the two groups.	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.
Pain Scores	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'.	48 hours after PACU arrival time

Collaborators and Investigators

• Sponsor: Stony Brook University
• Investigators: Principal Investigator: Eman Nada, MBBCH, Stony Brook University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: opioids; cervical fusion
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Musculoskeletal Abnormalities; Congenital Abnormalities; Bone Diseases, Developmental; Dysostoses; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Klippel-Feil Syndrome; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Central Nervous System Agents; Analgesics, Opioid
• Other Study ID Numbers: IRB2024-00227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No