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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04540848
• Other study ID #: HSC-MS-20-0430
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: November 20, 2021

Study information

• Verified date: October 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 20, 2021
• Est. primary completion date: November 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Group 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".
• Group 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".
• Group 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".

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)	The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).	24 hours post treatment
Primary	Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)	The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).	48 hours post treatment
Secondary	Number of patients who presented to Emergency room following surgery for pain control		24 hours post surgery
Secondary	Number of patients who presented to Emergency room following surgery for pain control		48 hours post surgery
Secondary	Number of over the counter(OTC) pain medications consumed by the patient		24 hours post surgery
Secondary	Number of OTC pain medications consumed by the patient		48 hours post surgery
Secondary	Number of prescription opioid medications consumed by the patient		24 hours post surgery
Secondary	Number of prescription opioid medications consumed by the patient		48 hours post surgery