Status:
COMPLETED
A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery
Lead Sponsor:
University of Utah
Conditions:
Opioid Use
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ambul...
Detailed Description
Prescription opioids are associated with addiction and accidental overdose, yet they continue to be the most commonly prescribed analgesics after ambulatory surgery. Multimodal analgesia is a promisi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04015908
Start Date
August 1 2019
End Date
January 31 2023
Last Update
July 8 2024
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84112