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ERAS Anesthesia Techniques for Knee Surgery Recovery (EKAT-TeleTPS Trial)
N/A
Recruiting
Led By David Kim, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative day 1-2 (24-48 hours post spinal induction)
Summary
This trial compares two different ways of numbing the area around the knee during surgery.
Who is the study for?
This trial is for English-speaking adults aged 18-65 with osteoarthritis, scheduled for knee replacement surgery using regional anesthesia. They must live within an hour of the hospital, be able to follow the study protocol, have a smartphone, and have home caregivers if needed. Excluded are those with diabetes, chronic pain or high pain catastrophizing scores, severe knee deformities, no home caregivers for catheter care, ASA status III/IV patients, those unable to manage a catheter at home or going to rehab facilities post-surgery.
What is being tested?
The trial compares two anesthesia techniques in knee replacements: one uses a single-shot nerve block plus local injections (PAI & IPACK), while the other adds a continuous nerve block through a catheter (ACC). The goal is to see which method provides better pain control during recovery.
What are the potential side effects?
Potential side effects may include discomfort at the injection site(s), possible infection risk from the catheter placement for continuous nerve blocks and potential numbness or weakness in the leg temporarily due to nerve blocks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative day 1-2 (24-48 hours post spinal induction)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative day 1-2 (24-48 hours post spinal induction)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Opioid consumption during 24-48 hour period
Secondary study objectives
Opioid consumption during post-anesthesia care unit (PACU) stay
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Continuous Adductor Canal Catheter (ACC)Active Control1 Intervention
Patients will receive a combined spinal epidural, PAI, IPACK, and a continuous adductor canal catheter
Group II: Adductor Canal block with sham catheterPlacebo Group1 Intervention
Patients will receive a combined spinal epidural, PAI, IPACK, and an adductor canal block. The patient will also receive a sham catheter.
Find a Location
Who is running the clinical trial?
Hospital for Special Surgery, New YorkLead Sponsor
250 Previous Clinical Trials
61,242 Total Patients Enrolled
David Kim, MDPrincipal InvestigatorHospital for Special Surgery, New York
1 Previous Clinical Trials
112 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe bending or twisting problem in your joints.You are scheduled to receive regional anesthesia during the study.You have a body mass index (BMI) that is higher than 40.You have problems with your liver or kidneys not working properly.You have been taking gabapentin or pregabalin regularly for more than 3 months.You are allergic to or cannot tolerate one of the study medications.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous Adductor Canal Catheter (ACC)
- Group 2: Adductor Canal block with sham catheter
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.