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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for managing pain after neck surgery. Participants will receive either standard pain medications or standard medications plus a nerve block, specifically the Inter-semispinalis Plane Block. This procedure numbs certain nerves and may reduce pain. The goal is to determine if the nerve block can decrease medication use, lessen pain, and shorten hospital stays. Individuals undergoing neck surgery from C2 to T3 who can provide consent might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative pain management strategies.

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 prior data suggests that the Inter-semispinalis Plane Block is safe for postoperative pain management?

Research has shown that the Inter-semispinalis Plane (ISP) Block is generally safe for patients and effectively reduces pain after neck surgery, potentially decreasing the need for strong painkillers like opioids.

One study highlighted that the ISP Block provides pain relief and is safe to use. Another study noted that patients experienced less pain and required fewer pain medications after receiving the ISP Block.

Overall, the ISP Block appears well-tolerated, with no major safety concerns reported in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the inter-semispinalis plane (ISP) block for managing postoperative pain because it offers a novel way to target nerves directly in the back of the neck using ultrasound guidance. Unlike traditional methods that rely heavily on medications like opioids, acetaminophen, and anti-inflammatories, this technique uses a precise injection of Bupivacaine, a local anesthetic, combined with Dexamethasone, an anti-inflammatory steroid, to potentially reduce pain more effectively and with fewer side effects. This direct nerve block approach could lead to quicker pain relief and a reduction in the need for systemic medications, which often come with a host of unwanted side effects.

What evidence suggests that the Inter-semispinalis Plane Block is effective for reducing postoperative pain in neck surgery?

This trial will compare Routine Pain Management with and without the addition of an Inter-semispinalis Plane (ISP) Block for postoperative pain. Research has shown that the ISP Block effectively manages pain after neck surgery. Studies have found that this method can reduce the need for opioids, which are strong painkillers. Patients who received the ISP block reported feeling less pain and required fewer medications after their surgery. The ISP block also aids in faster recovery and is considered safe. Overall, it appears to provide better pain relief compared to standard pain management alone. ^{1 2 6 7 8}

Who Is on the Research Team?

Eman Nada, MBBCH

Principal Investigator

Stony Brook University Hospital

Are You a Good Fit for This Trial?

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

Patients with a prior adverse reaction to bupivacaine or dexamethasone

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

I need an urgent medical procedure.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11078230/

Inter-Semispinalis Plane Block Versus General Anesthesia ... The ISP block proves to be an effective analgesic technique in posterior cervical spine surgery. It reduces opioid consumption, enhances pain ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06570577

Opioid Sparing Effect of an ISP Nerve Block on Post-Op ... 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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352556823000218

Analgesic efficacy of inter-semispinal fascial plane block in ... Inter-semispinal plane block (ISPB) represents an effective analgesic technique and reduces opioid consumption in both intra- and postoperative settings.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11571355/

Efficacy and Safety of Ultrasound Guided Inter-semispinal ... Our study results highlight that the ISP block provides better postoperative pain relief and is a relatively safe paraspinal cervical block that can be ...

5. researchgate.net researchgate.net/publication/364370780_Inter-semispinal_plane_ISP_block_for_postoperative_analgesia_following_cervical_spine_surgery_A_prospective_randomized_controlled_trial

Inter-semispinal plane (ISP) block for postoperative ... These results suggest that the ISPB can effectively reduce pain and analgesic requirements. Conclusions The ISPB is an effective analgesic ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818022003324

Inter-semispinal plane (ISP) block for postoperative ... Bilateral ultrasound-guided ISP block can provide decreased 24 h postoperative analgesic consumption as well as lower pain scores in the first 12 postoperative ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/21925682241254327

Efficacy and Safety of Ultrasound Guided Inter-semispinal ... Our study results highlight that the ISP block provides better postoperative pain relief and is a relatively safe paraspinal cervical block ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06003933

Inter-semispinal Plane Block and Cervical Spine Surgery The aim of this study is to evaluate the analgesic efficacy of ISP block in patients undergoing posterior cervical spine surgery.