← Back to Search

Regional Anesthesia for Back Surgery

Phase 4

Recruiting

Led By John O'Toole, MD

Research Sponsored by John O'Toole

Eligibility Criteria Checklist

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

Must have

Age 18-80

Undergoing one of 3 procedure types: 1) 2 or more levels of MIS decompression (e.g., discectomy, foraminotomy, laminectomy); 2) 1-3 levels of MIS transforaminal lumbar interbody fusion (TLIF) (with or without additional levels of MIS decompression for no greater than 3 total operative levels); 3) 1-3 levels of anterior lumbar interbody fusion (ALIF) or MIS lateral lumbar interbody fusion (LLIF) accompanied by posterior percutaneous instrumentation at the same levels

Must not have

Chronic kidney disease (stage 3 or greater), or hepatic failure

Opioid tolerant at the time of the surgical procedure--defined as consuming greater than 30mg of morphine milligram equivalents (MME) daily

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 1 day during inpatient admission up to 30 days

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will show whether adding regional anesthesia to common back surgery can reduce post-operative pain and the need for opioids.

Who is the study for?

This trial is for adults aged 18-80 undergoing specific lumbar spinal surgeries, who can consent to participate. It's not for those with advanced kidney or liver disease, opioid tolerance, pregnancy, ongoing worker's comp cases, allergies to local anesthetics like bupivacaine or clonidine, other surgical indications besides degenerative disease, pain devices in place, or conditions affecting pain evaluation.

What is being tested?

The study tests if adding regional anesthesia (Bupivacaine-Epinephrine plus clonidine) reduces the need for opioids after minimally invasive lumbar spine surgery. The goal is to see if this approach can help manage post-operative pain and lower long-term opioid use.

What are the potential side effects?

Possible side effects of the regional anesthesia could include reactions at the injection site such as numbness or tingling sensations due to nerve blockage from Bupivacaine-Epinephrine and low blood pressure or drowsiness from clonidine.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 80 years old.

Select...

I am scheduled for a specific spine surgery involving 1 to 3 levels of my spine.

Exclusion Criteria

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

Select...

I have advanced kidney disease or liver failure.

Select...

I have been taking more than 30mg of morphine or its equivalent daily.

Select...

I need surgery for a reason other than wear and tear, like cancer, infection, or injury.

Select...

I do not have a condition that would make it hard to assess my pain accurately after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days (+/- 7days) ,56 days (+/- 14 days) and 90 days (+/- 19) postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days (+/- 7days) ,56 days (+/- 14 days) and 90 days (+/- 19) postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days (+/- 7days) ,56 days (+/- 14 days) and 90 days (+/- 19) postoperatively for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Inpatient opioid consumption

Secondary study objectives

Length of hospital stay

Patient-reported pain and functional outcomes

Peri-operative complications

+5 more

Awards & Highlights

Drug Has Already Been Approved

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InvestigationalExperimental Treatment1 Intervention

Patients will undergo regional ESPB with bupivacaine plus clonidine in the holding area of the OR immediately prior to surgery. 30mL of 0.25% bupivacaine/1:200,000 epinephrine/50mcg clonidine will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance.

Group II: ControlPlacebo Group1 Intervention

Patients will receive a placebo injection of normal saline via the same ESPB technique. 30ml of normal saline will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance.

0 / 6Eligibility criteria met