Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California
Dates
study started
completion around
Principal Investigator
by William Kent
Headshot of William Kent
William Kent

Description

Summary

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.

Official Title

Randomized Controlled Trial Comparing Multimodal Pain Protocol Versus Hydrocodone-Acetaminophen for Post-Operative Pain Management in Orthopaedic Surgery Patients

Keywords

Post-operative Pain, Postoperative Pain, Acetaminophen, Ibuprofen, Gabapentin, Bupivacaine, Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine), Multimodal pain post-op management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Location

  • University of California, San Diego
    San Diego California 92093 United States

Lead Scientist at UCSD

  • William Kent
    Associate Clinical Professor, Orthopedic Surgery, Vc-health Sciences-schools. Authored (or co-authored) 38 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05690282
Phase
Phase 4 Postoperative Pain Research Study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated