ACL Repair and Multimodal Analgesia

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 Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine; Drug: placebo pills and injectables

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine; aggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane	Drug: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine; acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane
Placebo Comparator: placebo pills and injectables; standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane	Drug: placebo pills and injectables; receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 10 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	Up to 24 hours following surgery
Incidence of Post-Operative Pruritus	Pruritus in recovery and through the first 24 hours post-op.	Up to 24 hours following surgery
Post-Operative Pruritis Score	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.	Up to 24 hours following surgery
Sedation Scale	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.	Up to 24 hours following surgery
Impact of Block Characteristics on Pain Control		Up to 24 hours following surgery
Intraoperative Medication Use: Ketorolac and Lidocaine	All participants received standard induction medications.	From induction until arrival in post anesthesia care unit.
Intraoperative Medication Use: Fentanyl	All participants received standard induction medications.	From induction until arrival in post anesthesia care unit.
Number of Participants With Complications From the Procedure		Up to 24 hours following surgery
Time to Discharge	Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery).	Up to 24 hours following surgery

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: John A Shepler, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: May 13, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (Estimate): June 4, 2013

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Antipyretics; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Anesthetics, Local; Antimanic Agents; Ketamine; Gabapentin; Acetaminophen; Bupivacaine
• Other Study ID Numbers: 2012-0538; A530900 (Other Identifier: UW Madison); SMPH/ANESTHESIOLOGY (Other Identifier: UW Madison); 2017-0712 (Other Identifier: IRB ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No