TerminatedPhase 3

IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction

Stopped: PI leaving the institution, no subjects enrolled since 2019, and no other PI interested in taking it over.

United States7 participantsStarted 2019-08-30

Plain-language summary

This is a prospective study comparing femoral nerve block plus sciatic nerve block to femoral nerve block plus infiltration of the posterior knee capsule (IPACK) in patients undergoing arthroscopic anterior cruciate ligament reconstruction. Femoral nerve block via the adductor canal (FNB-AC) with IPACK may provide effective analgesia while avoiding the motor block involved with sciatic nerve block. The lack of motor block is important to facilitate postoperative ambulation and physical therapy.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients less than 21 years of age * American Society of Anesthesiologists physical status I and II * Undergoing elective anterior cruciate ligament reconstruction Exclusion Criteria: * They are unable or unwilling to take part in the study * History of allergy to any of the medications administered for the nerve block * Contraindication to peripheral nerve block * Patients who are unable to understand instructions or questions related to the study or the families required language interpretation * Patients who consume opioid medications for more than three days per week for more than a month prior to surgery

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Average Post-operative Pain Score

Timeframe: Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours

Trial details

NCT IDNCT03983941

SponsorSujana Dontukurthy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-07

Results submitted2021-07-27

View on ClinicalTrials.gov More Anterior Cruciate Ligament Tear trials