Phase 4 N=112 Randomized Quadruple-blind Treatment

ACL Repair and Multimodal Analgesia

Pain

Bottom Line

View on ClinicalTrials.gov: NCT01868425 ↗

Enrolled (actual)

112

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Opioid Consumption in the Immediate Postoperative Period — 12.0; 14.4 morphine mg equivalents

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine (Drug); placebo pills and injectables (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Opioid Consumption in the Immediate Postoperative Period	12.0; 14.4	—
SECONDARY Pain Scores During Recovery	2.3; 3.0; 4.8; 5.5; 3.4; 3.8	—
SECONDARY Number of Participants Who Received Medication for Nausea	8; 7; 6; 3	—
SECONDARY Post-Operative Incidence of Nausea	16; 12; 24; 23	—
SECONDARY Post-Operative Nausea Scores	1.2; 0.7; 2.2; 1.6	—
SECONDARY Incidence of Post-Operative Pruritus	8; 10; 13; 19	—
SECONDARY Post-Operative Pruritis Score	0.4; 0.7; 0.7; 1.2	—
SECONDARY Sedation Scale	5.0; 4.6; 4.2; 4.3	—
SECONDARY Impact of Block Characteristics on Pain Control	—	—
SECONDARY Intraoperative Medication Use: Ketorolac and Lidocaine	15.0; 14.7; 71.5; 65.6	—
SECONDARY Intraoperative Medication Use: Fentanyl	125; 128	—
SECONDARY Number of Participants With Complications From the Procedure	0; 0	—
SECONDARY Time to Discharge	64.8; 61.4; 132.1; 123.6	—

Summary

This study will evaluate the effectiveness of an aggressive multimodal regimen versus standard multimodal for Anterior Cruciate Ligament (ACL) repair using hamstring graft for patients having surgery in our outpatient surgicenter.

Eligibility Criteria

Inclusion Criteria

Patients of orthopedic surgeons on the study team scheduled for ACL repair using hamstring graft from the same leg will be considered for inclusion in this study. Other inclusion criteria are as follows:
American Society of Anesthesiologists (ASA) physical status 1-3
BMI of < 40 kg/m2
Consents to general anesthesia and pre-operative femoral nerve block for case

Exclusion Criteria

Any contraindication to a femoral nerve block
Allergy to local anesthetics, nonsteroidal anti-inflammatory medications, ketamine, acetaminophen, hydromorphone, oxycodone
Peripheral or central nervous system disease
Renal or hepatic impairment
History of opioid dependence or current regular narcotic use
Significant psychiatric disease
Pregnancy or lactation (by verbal report)
Seizure Disorder
History of post-operative nausea and vomiting
Latex allergy
Clinically significant cardiac or pulmonary disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01868425). 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.