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NCT03983941

IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction

Terminated Phase 3 Results posted Last updated 16 September 2021
What this trial tests

Phase 3 trial testing Ropivacaine injection in Anterior Cruciate Ligament Tear in 7 participants. Terminated before completion.

Timeline
30 August 2019
Primary endpoint
7 November 2019
7 November 2019

Quick facts

Lead sponsorSujana Dontukurthy
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment7
Start date30 August 2019
Primary completion7 November 2019
Estimated completion7 November 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sujana Dontukurthy

Who can join

Under 21, any sex, with Anterior Cruciate Ligament Tear. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Post-operative Pain Score Primary · Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours

Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center.

GroupValue95% CI
FNB-AC + Sciatic Nerve Block4.7± 3.368
FNB-AC + IPACK4± 2.905
Number of Opioid Doses Administered Secondary · Intra-operative and up to 48 hours post-discharge, an average of 48 hours

Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.

GroupValue95% CI
FNB-AC + Sciatic Nerve Block5.54 – 7
FNB-AC + IPACK3.82 – 5

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Ropivacaine injection

Trials testing the same drug.

Other recruiting trials for Anterior Cruciate Ligament Tear

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03983941.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing