Clinical trial NCT06570577: Opioid Sparing Effect of an ISP Nerve Block on Post-Op Pain Control in Posterior Cervical Spine Surgery
Official title: The Opioid Sparing Effect of an Inter-semispinalis Plane Block on Postoperative Pain Control in Posterior Cervical Spine Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Keywords: cervical fusion
opioids
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Lower opioid use
timeFrame: 48 hours post Post-Anaesthesia Care Unit (PACU) arrival time
Secondary outcomes:
measure: Lower opioid use.
timeFrame: 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.
measure: Lower opioid use
timeFrame: 24 hours after PACU arrival time
measure: Pain Scores
timeFrame: 48 hours after PACU arrival time
measure: Length of hospital stay
timeFrame: 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.
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
affiliation: Stony Brook University Hospital
name: Eman Nada, MBBCH
role: PRINCIPAL_INVESTIGATOR
References: