Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Location status: Recruiting
NCT Number: NCT06570577
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Stony Brook, New York, 11794, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A nerve block targeting the dorsal rami of the cervical spinal nerves can help alleviate postoperative incisional pain.
Other names: ISP nerve block
Routine Pain Management
Other names: Pharmacologic pain management
Time frame: 48 hours post Post-Anaesthesia Care Unit (PACU) arrival time
Comparison of the reduction in Morphine Milligram Equivalent (MME) dose of opioids consumed between the control group versus the nerve block group.
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.
MME from anesthesia induction time until PACU arrival time.
Time frame: 24 hours after PACU arrival time
MME for the 24 hours after PACU arrival time
Time frame: 48 hours after PACU arrival time
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'.
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.
The length of hospital stay will be compared between the two groups.
Contact information is provided by the study sponsor or research team.
Darcy Halper, B.S.
CONTACT
Eman Nada, MBBCH
CONTACT
Stony Brook University
Other
The Opioid Sparing Effect of an Inter-semispinalis Plane Block on Postoperative Pain Control in Posterior Cervical Spine Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07731295
Chemically-Induced Disorders, Mental Disorders
Providence, Rhode Island, United States
View Trial DetailsNCT07517679
Neurologic Manifestations, Pain
Lexington, Kentucky, United States
View Trial DetailsNCT07689461
Anxiety, Anxiety Disorders
Malatya, Turkey (Türkiye)
View Trial DetailsNCT06664177
Hernia, Hernia, Abdominal
Istanbul, Turkey (Türkiye)
View Trial Details