ACL Repair and Multimodal Analgesia

Ketamine

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.

Intervention / Treatment

  • multimodal:acetaminophen, gabapentin, ketamine, bupivacaine (DRUG)
    acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane
  • placebo pills and injectables (DRUG)
    receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds

Condition or Disease

  • Pain

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 55 Years
    Enrollment: 112 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Apr 01, 2013
    Primary Completion: Dec 01, 2017 ACTUAL
    Completion Date: Dec 01, 2017 ACTUAL
    Study First Posted: Jun 04, 2013 ESTIMATED
    Results First Posted: Mar 16, 2020 ACTUAL
    Last Updated: Mar 13, 2020

    Sponsors / Collaborators

    Lead Sponsor: University of Wisconsin, Madison
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Madison, Wisconsin, USA

    Participant Groups

    • aggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane

    • standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 55
    Age Groups: Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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 Outcomes

    • 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.

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

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

    • 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).

    • Pruritus in recovery and through the first 24 hours post-op.

    • 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.

    • 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.

    • Impact of Block Characteristics on Pain Control Up to 24 hours following surgery

    • All participants received standard induction medications.

    • All participants received standard induction medications.

    • Number of Participants With Complications From the Procedure Up to 24 hours following surgery

    • Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery).

    More Details

    NCT Number: NCT01868425
    Other IDs: 2012-0538
    Study URL: https://clinicaltrials.gov/study/NCT01868425
    Last updated: Sep 29, 2023