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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

Tracking Information
First Submitted Date  ICMJE May 13, 2013
First Posted Date  ICMJE June 4, 2013
Results First Submitted Date  ICMJE February 28, 2020
Results First Posted Date  ICMJE March 16, 2020
Last Update Posted Date March 30, 2020
Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2013)
opioid consumption in the immediate postoperative period [ Time Frame: time from post-operative arrival in recovery room to discharge from the outpatient surgery center ]
this data will be entered into the patients electronic medical record and collected from their chart once the patient has been discharged. the "immediate postoperative period" covers the patients entire time in the outpatient surgery center after they have entered the recovery room postoperatively. The amount of time they remain in the outpatient sugery center postoperatively varies from a minimum of 1 hour to a maximum of 10 hours and an average of 4 hours. .
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2020)
  • 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.
  • 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.
  • 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.
  • 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).
  • Incidence of Post-Operative Pruritus [ Time Frame: Up to 24 hours following surgery ]
    Pruritus in recovery and through the first 24 hours post-op.
  • 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.
  • 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.
  • Impact of Block Characteristics on Pain Control [ Time Frame: Up to 24 hours following surgery ]
  • Intraoperative Medication Use: Ketorolac and Lidocaine [ Time Frame: From induction until arrival in post anesthesia care unit. ]
    All participants received standard induction medications.
  • Intraoperative Medication Use: Fentanyl [ Time Frame: From induction until arrival in post anesthesia care unit. ]
    All participants received standard induction medications.
  • Number of Participants With Complications From the Procedure [ Time Frame: Up to 24 hours following surgery ]
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2013)
pain score [ Time Frame: up to 24 hours postoperatively ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ACL Repair and Multimodal Analgesia
Official Title  ICMJE ACL Repair and Multimodal Analgesia
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine
    acetaminophen, gabapentin, ketamine, bupivacaine and 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
Study Arms  ICMJE
  • Experimental: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine
    aggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane
    Intervention: Drug: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine
  • Placebo Comparator: placebo pills and injectables
    standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane
    Intervention: Drug: placebo pills and injectables
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2013)
112
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01868425
Other Study ID Numbers  ICMJE 2012-0538
2017-0712 ( Other Identifier: IRB ID )
A530900 ( Other Identifier: UW Madison )
SMPH/ANESTHESIOLOGY ( Other Identifier: UW Madison )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Wisconsin, Madison
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Wisconsin, Madison
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John A Shepler University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP