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General vs. Spinal Anesthesia for Lumbar Surgery

Phase 3

Waitlist Available

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

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

Must have

Patients aged 18-80 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the qor15 survey will be assessed preoperatively (in holding area). it will be assessed again immediately after surgery in the pacu and then at 2-weeks postoperatively at the patient's first follow-up visits

Awards & highlights

Study Summary

This trial is studying the best way to numb patients for lumbar decompression surgery - general anesthesia vs spinal anesthesia with a nerve block.

Who is the study for?

This trial is for adults aged 18-80 who need lumbar decompression surgery due to conditions like slipped disc or radiculopathy. Candidates must be able to consent and follow the study protocol, having one or two-level spine surgeries such as microdiscectomy. Those with morbid obesity, allergies to anesthetics used in the study, or involved in other drug trials are excluded.Check my eligibility

What is being tested?

The trial aims to find the best anesthesia method for lumbar surgery by comparing general anesthesia with a nerve block (GA + ESP) against spinal anesthesia with a nerve block (SA + ESP). Participants will be randomly assigned into two groups of 71 each to receive either standard care or the new combination.See study design

What are the potential side effects?

Potential side effects may include typical risks associated with anesthesia such as nausea, vomiting, sore throat from breathing tubes (with GA), backache, headache or difficulty urinating (with SA), and possible nerve damage from the nerve block.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from surgery through 24 hours postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from surgery through 24 hours postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and from surgery through 24 hours 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

QoR15 survey scores

Secondary outcome measures

Anesthetic(s) Time

Complications

NRS Survey Pain Scores

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SA + ESP BlockExperimental Treatment1 Intervention

Spinal Anesthesia: Patients will be provided with iv sedation, if desired, to facilitate placement of spinal anesthetic. Midazolam (2-5mg, iv), ketamine (up to 20 mg, lv) and/or propofol (0.1-0.2 mg/kg) will be permitted.

Group II: GA + ESP BlockActive Control1 Intervention

General anesthesia: induction of general anesthesia to facilitate endotracheal intubation: fentanyl (up to 2μg.kg.min-1), propofol (1-2 mg.kg-1), vecuronium (1-2 mg.kg-1).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor

243 Previous Clinical Trials

59,222 Total Patients Enrolled

Media Library

General Anesthetic (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05444751 — Phase 3

Slipped Disc Research Study Groups: SA + ESP Block, GA + ESP Block

Slipped Disc Clinical Trial 2023: General Anesthetic Highlights & Side Effects. Trial Name: NCT05444751 — Phase 3

General Anesthetic (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05444751 — Phase 3

Slipped Disc Patient Testimony for trial: Trial Name: NCT05444751 — Phase 3

Frequently Asked Questions

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

Are there any dangers associated with SA + ESP use?

"SA + ESP falls into the Phase 3 category, meaning that while there is efficacy data, multiple rounds of safety testing have been conducted. Our team at Power gives it a score of 3 for safety."

Answered by AI

Could I qualify to help with this research?

"142 individuals will be chosen for this study which requires that they have lumbar region and are between 18-80 years old."

Answered by AI

Is this research program currently looking for new participants?

"This particular clinical trial, as reflected on clinicaltrials.gov, is no longer recruiting patients for the study. The original posting was on 3/22/2022 and the most recent update was on 6/29/2022. Although this study has stopped recruitment, there are 95 other trials that are still looking for participants."

Answered by AI