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NCT03292926

A Novel Analgesia Technique for ACL Reconstruction

Completed Phase 4 Results posted Last updated 19 September 2024
What this trial tests

Phase 4 trial testing Bupivacaine in Anterior Cruciate Ligament Injury in 78 participants. Completed in 16 April 2020.

Timeline
4 October 2017
Primary endpoint
6 March 2020
16 April 2020

Quick facts

Lead sponsorHospital for Special Surgery, New York
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment78
Start date4 October 2017
Primary completion6 March 2020
Estimated completion16 April 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Hospital for Special Surgery, New York

Who can join

Adults 13 to 80, any sex, with Anterior Cruciate Ligament Injury. 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.

Pain While at Rest Primary · 24 hours post-block administration

Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.

GroupValue95% CI
Adductor Canal Block (ACB)3.84± 1.86
Adductor Canal Block & IPACK (ACB/IPACK)3.95± 2.58
Discharge Criteria Secondary · From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day

Time to meet discharge criteria utilizing the modified post anesthetic discharge scoring system. The frame represents when the measurements began, i.e. 3 hours after the administration of the anesthetic block. This represents time zero, at which recording would then begin.

GroupValue95% CI
Adductor Canal Block (ACB)180.67± 143.84
Adductor Canal Block & IPACK (ACB/IPACK)189.92± 254.55
Pain With Ambulation Secondary · 3 hours post-block administration on Post-operative day (POD) 0

NRS Pain score with ambulation \& stairs. A lower score is a better outcome. Score range is from 0 to 10.

NRS with Ambulation
GroupValue95% CI
Adductor Canal Block (ACB)1.59± 1.43
Adductor Canal Block & IPACK (ACB/IPACK)1.26± 1.23
NRS with Stairs
GroupValue95% CI
Adductor Canal Block (ACB)2.05± 1.92
Adductor Canal Block & IPACK (ACB/IPACK)2.1± 1.81

Sponsor's own description

A comparison of two anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor Canal Block with Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (ACB/IPACK)-- in patients undergoing bone-tendon-bone (BTB) anterior cruciate ligament (ACL) reconstruction.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Bupivacaine

Trials testing the same drug.

Other recruiting trials for Anterior Cruciate Ligament Injury

Currently open trials in the same condition.

Other Hospital for Special Surgery, New York trials

Trials by the same sponsor.

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/NCT03292926.

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