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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

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.

Condition or disease Intervention/treatment Phase
Pain Drug: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine Drug: placebo pills and injectables Not Applicable

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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
aggresssive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflourane
Drug: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine
acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflourane

Placebo Comparator: placebo pills and injectables
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




Primary Outcome Measures :
  1. 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. .


Secondary Outcome Measures :
  1. pain score [ Time Frame: up to 24 hours postoperatively ]


Information from the National Library of Medicine

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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:

    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

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
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: John A Shepler University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01868425    
Other Study ID Numbers: 2012-0538
2017-0712 ( Other Identifier: IRB ID )
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acetaminophen
Dexamethasone
Dexamethasone acetate
Ketorolac
Ketorolac Tromethamine
Fentanyl
Ketamine
Gabapentin
Ondansetron
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Analgesics