ISP Nerve Block for Postoperative Pain

Overseen By Eman Nada, MBBCH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stony Brook University

Must not be taking: Buprenorphine, Naltrexone, Methadone

Disqualifiers: Trauma, Infection, Pregnancy, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Intra-operative period, not expected to exceed 8 hours

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on medication-assisted treatments like buprenorphine, naltrexone, or methadone.

What data supports the effectiveness of the treatment Inter-semispinalis Plane Block for postoperative pain?

Research shows that the Inter-semispinalis Plane Block (ISP Block) is effective in reducing pain after cervical spine surgery, as it helps block pain signals from the nerves in the neck area. This technique is promising for managing pain without relying heavily on opioids, which are strong painkillers with potential side effects. ^{1 2 3 4 5}

Is the ISP Nerve Block generally safe for humans?

The Inter-semispinal Plane (ISP) block has been studied for pain relief after cervical spine surgery, and while the focus was on its effectiveness, no major safety concerns were reported in the studies available. This suggests it is generally safe for use in humans, but always consult with your healthcare provider for personalized advice. ^{1 2 3 5 6}

How does the ISP nerve block treatment differ from other treatments for postoperative pain?

The ISP nerve block is unique because it targets the dorsal rami of the cervical spinal nerves, providing pain relief specifically for posterior cervical spine surgeries. This technique is promising as it can reduce the need for opioids, which are commonly used for pain management but have significant side effects. ^{1 2 3 4 7}

What is the purpose of 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.

Research Team

Eman Nada, MBBCH

Principal Investigator

Stony Brook University Hospital

Eligibility Criteria

This trial is for individuals undergoing Posterior Cervical Spine Fusion surgery, who need pain management post-surgery. Participants will be randomly chosen to possibly receive a nerve block in addition to standard pain medication.

Inclusion Criteria

I understand and can agree to the study's procedures and risks.

I had surgery to fuse the vertebrae in my neck from C2 to C7.

Exclusion Criteria

I had surgery to fuse and relieve pressure on my spine due to an injury.

Patients with a prior adverse reaction to bupivacaine or dexamethasone

I need an urgent medical procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo posterior cervical spine surgery with or without an ISP nerve block

Intra-operative period, not expected to exceed 8 hours

1 visit (in-person, surgical procedure)

Postoperative Monitoring

Participants are monitored for pain scores and opioid use in the hospital

48 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 days

Hospital stay monitoring

Treatment Details

Interventions

• Inter-semispinalis Plane Block

Trial Overview The study is testing if an Inter-semispinalis Plane (ISP) Nerve Block can reduce the need for opioid painkillers after neck spine fusion surgery. It aims to see if this leads to lower pain levels and quicker hospital discharge.

Participant Groups

Group I: Routine Pain Management plus an Inter-semispinalis Plane Block Experimental Treatment 1 Intervention

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.

Group II: Routine Pain Management Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

References

1. United States pubmed.ncbi.nlm.nih.gov

Inter-semispinal plane (ISP) block for postoperative analgesia following cervical spine surgery: A prospective randomized controlled trial. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Ultrasound-guided erector spinae block versus mid-transverse process to pleura block for postoperative analgesia in lumbar spinal surgery. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Analgesic efficacy of inter-semispinal fascial plane block in Patients undergoing Cervical Spine Surgery through Posterior Approach: a randomized controlled trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Modified thoracolumbar Interfascial Plane Block Versus Erector Spinae Plane Block in Patients Undergoing Spine Surgeries: A Randomized Controlled Trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of Erector Spinae Plane Block Compared With Intrathecal Morphine in Postoperative Analgesia in Patients Undergoing Lumbar Spine Surgery: A Double-blind Prospective Comparative Study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of adding the Erector spinae plane block to standard anesthetic care in patients undergoing posterior lumbar interbody fusion surgery. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Erector spinae plane block vs interscalene brachial plexus block for postoperative analgesia management in patients who underwent shoulder arthroscopy. [2022]