Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ACL Repair and Multimodal Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01868425
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : March 16, 2020
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Drug: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine Drug: placebo pills and injectables Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ACL Repair and Multimodal Analgesia
Study Start Date : April 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Opioid Consumption in the Immediate Postoperative Period [ Time Frame: 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 :
  1. Pain Scores During Recovery [ Time Frame: 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.

  2. Number of Participants Who Received Medication for Nausea [ Time Frame: 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.

  3. Post-Operative Incidence of Nausea [ Time Frame: 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.

  4. Post-Operative Nausea Scores [ Time Frame: 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).

  5. Incidence of Post-Operative Pruritus [ Time Frame: Up to 24 hours following surgery ]
    Pruritus in recovery and through the first 24 hours post-op.

  6. Post-Operative Pruritis Score [ Time Frame: 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.

  7. Sedation Scale [ Time Frame: 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.

  8. Impact of Block Characteristics on Pain Control [ Time Frame: Up to 24 hours following surgery ]
  9. Intraoperative Medication Use: Ketorolac and Lidocaine [ Time Frame: From induction until arrival in post anesthesia care unit. ]
    All participants received standard induction medications.

  10. Intraoperative Medication Use: Fentanyl [ Time Frame: From induction until arrival in post anesthesia care unit. ]
    All participants received standard induction medications.

  11. Number of Participants With Complications From the Procedure [ Time Frame: Up to 24 hours following surgery ]
  12. Time to Discharge [ Time Frame: Up to 24 hours following surgery ]
    Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868425


Locations
Layout table for location information
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Layout table for investigator information
Principal Investigator: John A Shepler University of Wisconsin, Madison
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01868425    
Other Study ID Numbers: 2012-0538
2017-0712 ( Other Identifier: IRB ID )
A530900 ( Other Identifier: UW Madison )
SMPH/ANESTHESIOLOGY ( Other Identifier: UW Madison )
First Posted: June 4, 2013    Key Record Dates
Results First Posted: March 16, 2020
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetaminophen
Ketamine
Gabapentin
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Antipyretics
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Antimanic Agents