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Sedation-Epidural vs Spinal Anesthesia for Hip and Knee Surgery (RCT SEA vs SA Trial)

N/A

Recruiting

Led By Mina Morcos, Dr

Research Sponsored by Maisonneuve-Rosemont Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 3

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to compare the effectiveness of two different nerve block techniques in reducing postoperative complications like pain, low blood pressure, urine retention, and prolonged motor block after hip or knee replacement surgery. The

Who is the study for?

This trial is for adults needing outpatient hip or knee surgery who can safely receive anesthesia. It's not suitable for those with specific health conditions that could interfere with the study, allergies to anesthetics, or a history of substance abuse affecting pain perception.

What is being tested?

The study compares two types of numbing methods during surgery: spinal anesthesia and sedation-epidural anesthesia. The goal is to see which one leads to fewer complications like pain, low blood pressure, inability to urinate, and muscle weakness after surgery.

What are the potential side effects?

Possible side effects include discomfort at the injection site, headache, backache, nausea, difficulty urinating and in rare cases nerve damage. Both techniques may also cause low blood pressure or slow breathing if medication spreads too far.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 3 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse Events

Secondary study objectives

Adverse event

Complications related to the technique performed.

Conversion to GA

+14 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: SAActive Control1 Intervention

SA will be performed in the sitting or lateral position under sterile conditions. Spinal puncture will be performed at L2-L4 level using 50 mg of Clorotekal 1 or 2%. (intermediate-acting amide local anesthesia, commonly used) will be injected (32-34)

Group II: SED-EAActive Control1 Intervention

EA will be performed in the sitting or lateral position under sterile conditions. Epidural puncture will be performed at the L2-L4 level and an epidural catheter will be inserted into the epidural space. 10 ml of 2% xylocaine without epinephrine will be injected through the catheter and the dose will be titrated (up to 20 mL) to achieve complete sensory block up to T12 dermatoma measured with a level to ice.

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