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

ConditionPain, Postoperative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorStony Brook University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Capacity to provide informed consent

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inter-semispinalis Plane Block

    Procedure/Surgery

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

  • Opioids

    Drug

    Routine Pain Management

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Routine Pain ManagementActive comparator 1 intervention
Group B: Routine Pain Management plus an Inter-semispinalis Plane BlockExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Lower opioid use.

MME from anesthesia induction time until PACU arrival time.

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.
2

Lower opioid use

MME for the 24 hours after PACU arrival time

Time frame
24 hours after PACU arrival time
3

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'.

Time frame
48 hours after PACU arrival time
4

Length of hospital stay

The length of hospital stay will be compared between the two groups.

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stony Brook University

Lead sponsor

Source ClinicalTrials.gov
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