Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Primary Endpoint
- Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
Study Overview
Brief Summary
The purpose of this study is to see if Exparel, used intraoperatively by injecting at the surgical site, followed by a Supraclavicular nerve block with bupivacaine in the recovery room, will provide better pain scores for patients at 24 and 48 hours post operatively than, 1)Bupivacaine Hydrochloride (HCL) injection at the surgical site, with a supraclavicular block in Post-anesthesia care unit(PACU), or 2)a supraclavicular block in PACU without any kind of injection at the surgical site.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •distal radius fractures
- •undergoing Open reduction internal fixation (ORIF) at Lyndon B Johnson Ambulatory Surgical Center (LBJ ASC)
Exclusion Criteria
- •pregnancy
- •history of chronic pain conditions
- •currently taking opioids
Arms & Interventions
Exparel plus supraclavicular block
Intervention: Group A (Exparel plus supraclavicular block) (Drug)
Bupivacaine HCL plus supraclavicular block
Intervention: Group B (Bupivacaine HCL plus supraclavicular block) (Drug)
supraclavicular block only
Intervention: Group C(supraclavicular block only) (Drug)
Outcomes
Primary Outcomes
Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
Time Frame: 48 hours post treatment
The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).
Secondary Outcomes
- Number of prescription opioid medications consumed by the patient(48 hours post surgery)
- Number of patients who presented to Emergency room following surgery for pain control(48 hours post surgery)
- Number of over the counter(OTC) pain medications consumed by the patient(24 hours post surgery)
- Number of OTC pain medications consumed by the patient(48 hours post surgery)
Investigators
Erikka L Washington
Assistant Professor
The University of Texas Health Science Center, Houston