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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04540848

Enrollment

Registered

2020-09-07

Start date

2021-03-01

Completion date

2021-11-20

Last updated

2021-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

Keywords

Brachial plexus block, Multimodal pain control for Distal Radius surgery, Exparel, Bupivacaine, Distal Radius Pain Control, Post operative pain Control, Supraclavicular nerve block

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.

Interventions

DRUGGroup A (Exparel plus supraclavicular block)

Patients will receive 20 cc (266 mg) of Exparel injected in the distal radius area and a supraclavicular block in the recovery room.The supraclavicular blocks will be ultrasound guided and consist of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the corner pocket.

DRUGGroup B (Bupivacaine HCL plus supraclavicular block)

Patients will receive 20 cc of Bupivacaine 0.25% (50mg) in the distal radius area.In the recovery room the patient will be given the supraclavicular block which will be ultrasound guided and consisting of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the corner pocket.

DRUGGroup C(supraclavicular block only)

In the recovery room the patient will be given the supraclavicular block which will be ultrasound guided and consisting of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the corner pocket.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)	24 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

Measure	Time frame
Number of patients who presented to Emergency room following surgery for pain control	24 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
Number of prescription opioid medications consumed by the patient	24 hours post surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026