ACL Repair and Multimodal Analgesia

Phase 4

Completed

Conditions: Pain

Interventions: Drug: placebo pills and injectables

Registration Number: NCT01868425

Lead Sponsor: University of Wisconsin, Madison

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 112

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
placebo pills and injectables	placebo pills and injectables	standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane

Primary Outcome Measures

Name	Time	Method
Opioid Consumption in the Immediate Postoperative Period	Up to 10 hours	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.

Secondary Outcome Measures

Name	Time	Method
Post-Operative Incidence of Nausea	Up to 24 hours following surgery	Incidence of nausea as recorded in the electronic medical record (EMR) in the recovery room through the first 24-hrs post-op.
Incidence of Post-Operative Pruritus	Up to 24 hours following surgery	Pruritus in recovery and through the first 24 hours post-op.
Sedation Scale	Up to 24 hours following surgery	Sedation scale measured in recovery room, 1-hr post op, and 24 hrs op. The Sedation Scale is scored from 0-10 where 0 = normal, no sleepier than average, 10 = sleepy, hard to stay awake.
Pain Scores During Recovery	up to 24 hours postoperatively	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.
Post-Operative Pruritis Score	Up to 24 hours following surgery	Participants will be asked to rate their pruritis on a scale of 0 (no itching) - 10 (worst itchiness) while in post-op recovery room and then at 24 hours post-op via phone call.
Intraoperative Medication Use: Fentanyl	From induction until arrival in post anesthesia care unit.	All participants received standard induction medications.
Intraoperative Medication Use: Ketorolac and Lidocaine	From induction until arrival in post anesthesia care unit.	All participants received standard induction medications.
Number of Participants Who Received Medication for Nausea	Up to 24 hours following surgery	Number of participant who received medication for nausea prior to discharge and after discharge, up to 24 hours post-op.
Post-Operative Nausea Scores	Up to 24 hours following surgery	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).
Impact of Block Characteristics on Pain Control	Up to 24 hours following surgery
Number of Participants With Complications From the Procedure	Up to 24 hours following surgery
Time to Discharge	Up to 24 hours following surgery	Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery).