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SA for Knee Injuries and Disorders (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

RCT SEA vs SA Trial 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.Check my eligibility

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.See study design

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.

RCT SEA vs SA Trial 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

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

Primary outcome measures

Adverse Events

Secondary outcome measures

Adverse event

Complications related to the technique performed.

Conversion to GA

+14 more

RCT SEA vs SA 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Pierre DroletUNKNOWN

Mina Wahba MorcosUNKNOWN

Maisonneuve-Rosemont HospitalLead Sponsor

99 Previous Clinical Trials

36,191 Total Patients Enrolled

Frequently Asked Questions

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

Is the clinical trial open to participants who have surpassed their 25th year of age?

"Eligible candidates for this study are individuals aged between 18 and 80 years. There are a total of 193 research studies catering to participants under 18 years old, as well as 773 trials designed for those over the age of 65."

Answered by AI

How large is the participant pool for this particular medical study?

"Indeed, details on clinicaltrials.gov highlight that this trial is actively seeking participants. The trial was initially listed on March 15th, 2023 and last modified on March 20th, 2024. It aims to recruit 132 patients from a single site."

Answered by AI

Are individuals currently eligible to participate in this ongoing research study?

"Affirmative. The details on clinicaltrials.gov highlight that this particular trial is actively searching for suitable candidates. Initially listed on March 15, 2023, the trial underwent its latest revision on March 20, 2024. A total of 132 participants are sought from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spinal Anesthesia in Outpatient Hip or Knee Arthroplasty.

Pascal André Vendittoli 2023. "Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spinal Anesthesia in Outpatient Hip or Knee Arthroplasty.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06332443.