Phase 4 N=78 Randomized Triple-blind Treatment

A Novel Analgesia Technique for ACL Reconstruction

Anterior Cruciate Ligament Injury

Bottom Line

View on ClinicalTrials.gov: NCT03292926 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2022

Primary outcome: Primary: Pain While at Rest — 3.84; 3.95 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Bupivacaine (Drug); Ultrasound (Device); Dexamethasone (Drug)
Age: Pediatric, Adult, Older Adult · 13+ yrs
Sex: All
Sponsor: Hospital for Special Surgery, New York
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain While at Rest	3.84; 3.95	—
SECONDARY Discharge Criteria	180.67; 189.92	—
SECONDARY Pain With Ambulation	1.59; 1.26; 2.05; 2.1	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Patients undergoing BTB ACL reconstruction with participating surgeon
Age 13 or greater
Planned use of regional anesthesia
Ability to follow study protocol
English speaking (secondary outcomes include questionnaires validated in English only)

Exclusion Criteria

Hepatic or renal insufficiency
Younger than 13 years old
Patients undergoing general anesthesia
Allergy or intolerance to one of the study medications
BMI > 40
Diabetes
American Society of Anesthesiology (ASA) score IV
Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
Chronic opioid use (taking opioids for longer than 3 months, or daily morphine equivalent of >5mg/day for one month)
Non-English speaking

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03292926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.