Phase 4
N=100
A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery
Opioid Use
Bottom Line
View on ClinicalTrials.gov: NCT04015908 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Amount of Pain Experienced — 28; 35 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Celecoxib (Drug); Acetaminophen (Drug); Pregabalin (Drug); Oxycodone (Drug); Percocet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of Pain Experienced |
28; 35 | — |
| SECONDARY Amount of Nausea Experienced |
0; 0 | — |
| SECONDARY Amount of Itching Experienced |
0; 0 | — |
| SECONDARY Amount of Oxycodone Used |
0; 8 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04015908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.