Opioid Sparing Effect of an ISP Nerve Block on Post-Op Pain Control in Posterior Cervical Spine Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inter-semispinalis Plane Block, Opioids.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Opioid Sparing Effect of an Inter-semispinalis Plane Block on Postoperative Pain Control in Posterior Cervical Spine Surgery
Overview
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.
Interventions
- Procedure Inter-semispinalis Plane Block
A nerve block targeting the dorsal rami of the cervical spinal nerves can help alleviate postoperative incisional pain. - Drug Opioids
Routine Pain Management
Primary outcome measures
- Lower opioid use [Time frame: 48 hours post Post-Anaesthesia Care Unit (PACU) arrival time]
Secondary outcome measures (4)
- 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.]
- Lower opioid use [Time frame: 24 hours after PACU arrival time]
- Pain Scores [Time frame: 48 hours after PACU arrival time]
- 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.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stony Brook University Hospital — Stony Brook
Identifiers
NCT: NCT06570577 · IRB2024-00227