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

Study Overview
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Brief Summary
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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.

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

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Group A (Exparel plus supraclavicular block)
* Drug: Group B (Bupivacaine HCL plus supraclavicular block)
* Drug: Group C(supraclavicular block only)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exparel plus supraclavicular block<br> | Drug: Group A (Exparel plus supraclavicular block)<br>* 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.<br>|
| Active Comparator: Bupivacaine HCL plus supraclavicular block<br> | Drug: Group B (Bupivacaine HCL plus supraclavicular block)<br>* 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.<br>|
| Active Comparator: supraclavicular block only<br> | Drug: Group C(supraclavicular block only)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who presented to Emergency room following surgery for pain control |  | 24 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 | 
| Number of prescription opioid medications consumed by the patient |  | 24 hours post surgery | 
| Number of prescription opioid medications consumed by the patient |  | 48 hours post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brachial plexus block, Multimodal pain control for Distal Radius surgery, Exparel, Bupivacaine, Distal Radius Pain Control, Post operative pain Control, Supraclavicular nerve block