Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Bupivacaine HCl 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
Bupivacaine hydrochloride (Hospira, Inc) is an FDA approved, local, injectable indicated for the production of local or regional anesthesia or analgesia for surgery.
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Placebo Comparator: Saline Immediately prior to surgical wound closure, participants randomized to saline, will receive saline injections along the closure site. |
Drug: Saline
Normal saline injections.
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Outcome Measures
Primary Outcome Measures
- Reported opioid and non-opioid pain medications taken [3 Days Post-Surgery]
Patients will report the amount of pain medications taken 3 days immediately following surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age
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Receiving cutaneous surgery
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In good general health as assessed by the investigator
Exclusion Criteria:
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Participants with an allergy to bupivacaine or other amide anesthetics
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Participants unwilling to sign an IRB approved consent form
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Participants with a contraindication to narcotic medication
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Participants who are pregnant or will become pregnant
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Northwestern University Department of Dermatology | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
Investigators
- Principal Investigator: Murad Alam, MD, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU00211424