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ISP Nerve Block for Postoperative Pain

N/A

Waitlist Available

Led By Eman Nada, MBBCH

Research Sponsored by Stony Brook University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Having Posterior Cervical Spine Fusion from C2 - C7

Be older than 18 years old

Must not have

Fusion and decompression due to trauma

Emergent procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing whether adding a nerve block procedure to pain medication for patients undergoing neck surgery can reduce the need for opioid medication, lower pain levels, and help patients leave the hospital sooner."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, possible nerve damage, or allergic reactions from the nerve block procedure. Opioids can cause drowsiness, constipation, nausea, addiction risk and other side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I need an urgent medical procedure.

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I am having or have had a complex or corrective surgery.

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I am not pregnant on the day of my surgery.

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I have an infection near my neck where a procedure is planned.

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My fasting blood sugar was above 150 mg/dL before surgery.

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I have chronic pain not caused by my neck.

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I have a genetic condition affecting my red blood cells or issues with my heart or lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours after pacu arrival time

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours after pacu arrival time

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours after pacu arrival time for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lower opioid use

Secondary study objectives

Length of hospital stay

Lower opioid use.

Pain Scores

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Routine Pain Management plus an Inter-semispinalis Plane BlockExperimental Treatment1 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 ManagementActive Control1 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.

0 / 9Eligibility criteria met