Comparing Perioperative Outcomes in Pain Control

University of California San Diego

Status and phase

Active, not recruiting

Phase 4

Conditions

Post-operative Pain

Treatments

Drug: Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)

Study type

Interventional

Funder types

Other

Identifiers

NCT05690282

210031

Details and patient eligibility

About

This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an orthopaedic injury requiring surgery. Patients who consent to study participation will be randomized to receive either the multimodal pain management protocol or standard oral hydrocodone-acetaminophen for post-operative pain management. Data on opioid usage, pain control, and functional status will be collected for each participant. After 3 years of data collection, investigators will analyze this data to provide further insight in determining appropriateness of pain regimens that reduce the overall opioid consumption. Given the widespread opioid epidemic, it is imperative to develop alternative means to appropriately manage pain in orthopaedic surgery patients.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Orthopaedic injury requiring surgery
Evaluation and treatment at UCSD
Age 18years or older
Ability to understand the content of the patient information/Informed Consent Form
Signed and dated Institutional Review Board (IRB) approved written informed consent

Exclusion criteria

Polytrauma
Any not medically managed severe systemic disease
Their doctor has decided that it is in the patient's best interest to receive pain management regimen of one type vs. the other.
The patient prefers one type of pain management protocol and is not willing to be randomized.
Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment or confound pain control
Pregnancy or women planning to conceive within the subject participation period (1 year)

o Pregnancy will be self-reported and no test will be performed to test for it.
Prisoner
Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study.