ACL Repair and Multimodal Analgesia

University of Wisconsin, Madison112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

112

Conditions

Pain

Interventions

multimodal:acetaminophen, gabapentin, ketamine, bupivacaineDRUG

acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane

placebo pills and injectablesDRUG

receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Opioid Consumption in the Immediate Postoperative Period

This data will be entered into the participants electronic medical record and collected from their chart once the participant has been discharged. The "immediate postoperative period" covers the participant's entire time in the outpatient surgery center after they have entered the recovery room postoperatively. The amount of time they remain in the outpatient surgery center postoperatively varies from a minimum of 1 hour to a maximum of 10 hours and an average of 4 hours.

Time frame: Up to 10 hours

Secondary Outcomes

Pain Scores During Recovery

Pain scores during recovery period through the first 24 hours of recovery, recorded upon arrival to recovery room, 1-hr post-op, 24-hrs post-op. This outcome reports lowest and highest pain score since discharge to 24 hour phone call. Pain scores are collected verbally on a scale of 0-10 where 10 is the most severe pain.

Time frame: up to 24 hours postoperatively

Number of Participants Who Received Medication for Nausea

Number of participant who received medication for nausea prior to discharge and after discharge, up to 24 hours post-op.

Time frame: Up to 24 hours following surgery

Post-Operative Incidence of Nausea

Incidence of nausea as recorded in the electronic medical record (EMR) in the recovery room through the first 24-hrs post-op.

Time frame: Up to 24 hours following surgery

Post-Operative Nausea Scores

Nausea scores will be collected in post-operative recovery and 24 hours later (via phone). The participant will be asked to rate their nausea on a scale of 0 (no nausea) - 10 (worst possible).

Time frame: Up to 24 hours following surgery

Data from ClinicalTrials.gov

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