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Clinical Trials/NCT04540848
NCT04540848
Withdrawn
Phase 4

Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?

Overview

Phase
Phase 4
Intervention
Group A (Exparel plus supraclavicular block)
Conditions
Post Operative Pain
Sponsor
The University of Texas Health Science Center, Houston
Primary Endpoint
Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
Status
Withdrawn
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
November 20, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Erikka L Washington

Assistant Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

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)

Bupivacaine HCL plus supraclavicular block

Intervention: Group B (Bupivacaine HCL plus supraclavicular block)

supraclavicular block only

Intervention: Group C(supraclavicular block only)

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)

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