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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

Must not have

Surgery with planned need for postoperative surgical drain

Allergies or contraindications to any study anesthetic or analgesic medications

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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

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I am between 18 and 80 years old.

Exclusion Criteria

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

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I will need a drain after my upcoming surgery.

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I am not allergic to any medications used in this study.

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My BMI is over 35.

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

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

Primary study objectives

QoR15 survey scores

Secondary study objectives

Anesthetic(s) Time

Complications

NRS Survey Pain Scores

+2 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

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 / 4Eligibility criteria met