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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I am between 18 and 80 years old.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Inpatient opioid consumption

Secondary outcome measures

Length of hospital stay

Patient-reported pain and functional outcomes

Peri-operative complications

+5 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

John O'TooleLead Sponsor

John O'Toole, MDPrincipal InvestigatorRush University Medical Center

Media Library

Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine Clinical Trial Eligibility Overview. Trial Name: NCT05029726 — Phase 4

Degenerative Disc Disease Research Study Groups: Control, Investigational

Degenerative Disc Disease Clinical Trial 2023: Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine Highlights & Side Effects. Trial Name: NCT05029726 — Phase 4

Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05029726 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are additional participants being welcomed into this research project?

"Affirmative, the information on clinicaltrials.gov confirms that this research is currently underway and in need of volunteers to take part. It was initially posted on February 1st 2022 and recently updated on April 25th 2022. This study has a requirement for 125 participants over one location."

Answered by AI

Is Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine a safe medication for human consumption?

"Due to its Phase 4 status, this combination of bupivacaine-epinephrine 0.25%-1:200,000 injectable solution and clonidine has been assessed as 3 on a scale from 1 to 3 for safety by our team at Power."

Answered by AI

What criteria must be met in order to qualify for this clinical investigation?

"This medical study is recruiting 125 willing and able adults aged between 18-75 with synovial cyst. Candidates must also be open to 1 of 3 procedures: MIS decompression (discectomy, foraminotomy or laminectomy), transforaminal lumbar interbody fusion (TLIF) + possible extra levels, anterior lumbar interbody fusion (ALIF)/lateral lumbar interbody fusion(LLIF) combined with posterior instrumentation at the same level."

Answered by AI

For which medical conditions is Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine typically prescribed?

"Unresponsive bradycardia, permphigus, and pupil can all be managed with the administration of Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution accompanied by clonidine."

Answered by AI

What other scientific experiments have been undertaken to analyze the effects of Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution combined with clonidine?

"As of present, 143 trials investigating Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine are in progress with 29 studies being conducted at Phase 3. While a majority of these examinations originate from Germantown, Tennessee, 251 locations globally are running investigations into the medication combination."

Answered by AI

What is the size of the participant pool for this experiment?

"Confirmed. Clinicaltrials.gov confirms that this experiment, which was first launched on February 1st 2022, is presently enrolling patients. 125 people are required for the study at a single centre."

Answered by AI