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A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04015908
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
University of Utah

Brief Summary:

The primary objective of this trial is to determine whether the combination of three non-opioid analgesics (multimodal analgesia) can significantly reduce or eliminate the need for opioids after ambulatory surgery.

A secondary objective would be to present credible data for insurance providers about the opioid sparing effect of these medications. This data may encourage insurance providers to support payment for short term use of certain analgesics that currently require prior authorization.


Condition or disease Intervention/treatment Phase
Opioid Use Drug: Celecoxib Drug: Acetaminophen Drug: Pregabalin Drug: Oxycodone Drug: Percocet Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Arm Intervention/treatment
Experimental: multi-modal

3 Different Non-opioid pain medication taken every 6 hours

Celecoxib 100mg

Acetaminophen 325mg

Pregabalin 50 mg

Plus, for breakthrough pain

oxycodone 5-10 mg will be taken every 4 hours as needed for pain.

Drug: Celecoxib
Celecoxib 100mg

Drug: Acetaminophen
Acetaminophen 325mg

Drug: Pregabalin
Pregabalin 50 mg

Drug: Oxycodone
oxycodone 5-10 mg

Active Comparator: Control
7 day supply of Percocet (oxycodone 5mg/acetaminophen 325 mg) to be taken 1-2 by mouth every 4 hours as needed for pain.
Drug: Percocet
Percocet (oxycodone 5mg/acetaminophen 325 mg)




Primary Outcome Measures :
  1. Amount of Pain experienced [ Time Frame: Directly after waking every morning for 7 days post-operative ]
    Pain as measured by a 0-10 Visual Analog Scale (VAS) pain scale

  2. Amount of Pain experienced [ Time Frame: Directly before going to sleep each night for 7 days post-operative ]
    Pain as measured by a 0-10 Visual Analog Scale (VAS) pain scale


Secondary Outcome Measures :
  1. Amount of Nausea experienced [ Time Frame: Directly after waking every morning for 7 days post-operative ]
    Nausea as measured by a 0-11 VAS nausea scale

  2. Amount of Itching experienced [ Time Frame: Directly after waking every morning for 7 days post-operative ]
    Itching as measured by a 0-11 VAS nausea scale

  3. Amount of Nausea experienced [ Time Frame: Directly before going to sleep each night for 7 days post-operative ]
    Nausea as measured by a 0-11 VAS nausea scale

  4. Amount of Itching experienced [ Time Frame: Directly before going to sleep each night for 7 days post-operative ]
    Itching as measured by a 0-11 VAS nausea scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients between the ages of 18 and 65 having one of three elective procedures as an outpatient. These procedures are associated with moderate to severe postoperative pain (anterior cruciate ligament reconstruction (knee), ankle ligament reconstruction (foot/ankle), or ligament reconstruction with tendon interposition (hand))
  • Patients should have operative risk category of American Society of Anesthesiologists (ASA) 1 or 2 .
  • Patients weighing between 70-100kg will be included to allow standardization of medication dosing

Exclusion Criteria:

  • Allergy to Study Medications
  • Previous History of Chronic Opioid Use
  • Patient Refusal to Participate
  • Known of Suspected History of Sleep Apnea
  • Known History of Chronic Pain Syndrome
  • Weight less than 70kg or greater than 100kg due to standardization of medication doses.
  • Revision Surgery
  • Inability to take study medications due to medication incompatibility or co-existing disease
  • Patients refusing or unable to receive US guided nerve block for postoperative pain
  • Patients unable to read and comprehend written consent document

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): NCT04015908


Contacts
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Contact: Ami Stuart, PhD 8017934800 ami.stuart@hsc.utah.edu

Locations
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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Ami R Stuart, PhD    801-793-4800    ami.stuart@hsc.utah.edu   
Principal Investigator: Jeffrey Swenson, MD         
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Jeffrey Swenson, MS University of Utah

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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT04015908    
Other Study ID Numbers: 121505
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Acetaminophen
Celecoxib
Acetaminophen, hydrocodone drug combination
Pregabalin
Oxycodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Analgesics, Opioid
Narcotics