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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
Last Update Posted : June 20, 2019
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
Last Update Posted Date June 20, 2019
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: 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. .
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2013)
pain score [ Time Frame: up to 24 hours postoperatively ]
Original Secondary Outcome Measures  ICMJE Same as current
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 ACL repair using hamstring graft for patients having surgery in our outpatient surgicenter.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
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, sevoflourane
  • Drug: placebo pills and injectables
    receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflourane plus placebos of intervention arm meds
Study Arms  ICMJE
  • Experimental: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine
    aggresssive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflourane
    Intervention: Drug: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine
  • Placebo Comparator: placebo pills and injectables
    standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflourane
    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:

    1. American Society of Anesthesiologists (ASA) physical status 1-3
    2. 18-55 years of age, inclusive
    3. BMI of < 40 kg/m2.
    4. Consents to general anesthesia and pre-operative femoral nerve block for case.

      Exclusion Criteria:

      Exclusion criteria include:

    1. Any contraindication to a femoral nerve block
    2. Allergy to local anesthetics, nonsteroidal anti-inflammatory medications, ketamine, acetaminophen, hydromorphone, oxycodone
    3. Peripheral or central nervous system disease
    4. Renal or hepatic impairment
    5. History of opioid dependence or current regular narcotic use
    6. Significant psychiatric disease
    7. Pregnancy or lactation (by verbal report)
    8. Seizure Disorder
    9. History of post- operative nausea and vomiting
    10. Latex allergy
    11. 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John A Shepler University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date June 2019

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