Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery

Study Overview
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Brief Summary
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The purpose of this study is to determine if the addition of bupivacaine HCl injections will improve pain control after skin surgery. This is a randomized clinical trial. Approximately 100 participants will be randomized to receive either bupivacaine HCl or saline injections to help with the postsurgical pain. Patients will be provided with a take-home journal to complete indicating when and how much pain medication they required for the 3 days immediately following surgery. Participants will return the journal in-person at a follow up visit 7-21 days post-op. This study was a pilot study designed to determine the feasibility of this procedure. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be invited and considered for enrollment.

Official Title
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Locally Administered Bupivacaine Hydrochloride for Post-operative Pain Control in Cutaneous Surgery: A Randomized Controlled Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Bupivacaine Hydrochloride
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age Receiving cutaneous surgery In good general health as assessed by the investigator Exclusion Criteria: Participants with an allergy to bupivacaine or other amide anesthetics Participants unwilling to sign an IRB approved consent form Participants with a contraindication to narcotic medication Participants who are pregnant or will become pregnant Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine HCl<br>Immediately prior to surgical wound closure, participants randomized to the bupivacaine arm will be injected with bupivacaine HCl along the closure site. | Drug: Bupivacaine Hydrochloride<br>* Bupivacaine hydrochloride (Hospira, Inc) is an FDA approved, local, injectable indicated for the production of local or regional anesthesia or analgesia for surgery.<br>|
| Placebo Comparator: Saline<br>Immediately prior to surgical wound closure, participants randomized to saline, will receive saline injections along the closure site. | Drug: Saline<br>* Normal saline injections.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported opioid and non-opioid pain medications taken | Patients will report the amount of pain medications taken 3 days immediately following surgery | 3 Days Post-Surgery |