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MCP Block for Cervical Spine Fusion (MCP Trial)

Phase 4

Recruiting

Led By Pranjali Kainkaryam, MD

Research Sponsored by Hartford Hospital

Eligibility Criteria Checklist

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

Must have

Patients are scheduled for elective primary posterior CSFS to be performed by one of the spine surgeons in the study.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 72nd postoperative hour and at 2 weeks (+/- 7 days) after discharge via a phone call

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial compares MCP block to sham block to assess if MCP reduces post-op pain. Researchers will also look at opioid consumption, non-opioid analgesics, PONV, LOS, safety, patient satisfaction.

Who is the study for?

This trial is for patients aged 40-80 undergoing posterior cervical spine fusion surgery. They must be able to speak and read English, have an ASA score I-IV, and the surgery should be their first of this kind performed by a participating surgeon.

What is being tested?

The study tests if a Multifidus Cervicis Plane (MCP) block with Bupivacaine, Epinephrine, and Dexamethasone reduces pain more effectively than a sham saline injection in the first 24 hours after neck fusion surgery. It also looks at opioid use post-surgery, other painkillers needed, nausea/vomiting occurrences, hospital stay duration, safety of interventions, patient satisfaction with pain management and overall surgical experience.

What are the potential side effects?

Possible side effects may include reactions at the injection site like bruising or soreness. There's also a risk of experiencing lower blood pressure or heart rate due to Bupivacaine or Epinephrine. Dexamethasone might cause increased blood sugar levels or mood changes.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am scheduled for a specific spine surgery by a study surgeon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-24 hours; 24-48 hours; 48-72 hours and at 2 weeks (+/- 7 days) after discharge via a phone call.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-24 hours; 24-48 hours; 48-72 hours and at 2 weeks (+/- 7 days) after discharge via a phone call.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-24 hours; 24-48 hours; 48-72 hours and at 2 weeks (+/- 7 days) after discharge via a phone call. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The maximum postoperative pain score

Secondary study objectives

Antiemetics used

Hospital and Post Anesthesia Care Unit length of stay

Non- opioid analgesics use

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MCP BlockExperimental Treatment3 Interventions

Bilateral Multifidus Cervicis plane block using 30 mL of 0.25% bupivacaine + 0.5 mL (5 mg) preservative-free dexamethasone + 0.1 mL epinephrine 1:400,000.

Group II: Sham BlockPlacebo Group1 Intervention

Bilateral sham block using 3 mL of normal saline injections subcutaneously on the neck.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Epinephrine

2014

Completed Phase 4

~3890

Bupivacain

2022