A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery

121505

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.

2019-08-01

2023-01-31

2023-01-31

Completed

Early phase I

100

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2023-07-20