Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery
Primary Purpose
Pain, Postoperative
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
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
Sites / Locations
- Northwestern University Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Bupivacaine HCl
Saline
Arm Description
Immediately prior to surgical wound closure, participants randomized to the bupivacaine arm will be injected with bupivacaine HCl along the closure site.
Immediately prior to surgical wound closure, participants randomized to saline, will receive saline injections along the closure site.
Outcomes
Primary Outcome Measures
Reported opioid and non-opioid pain medications taken
Patients will report the amount of pain medications taken 3 days immediately following surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT04260854
First Posted
February 6, 2020
Last Updated
March 29, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT04260854
Brief Title
Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery
Official Title
Locally Administered Bupivacaine Hydrochloride for Post-operative Pain Control in Cutaneous Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine HCl
Arm Type
Active Comparator
Arm Description
Immediately prior to surgical wound closure, participants randomized to the bupivacaine arm will be injected with bupivacaine HCl along the closure site.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Immediately prior to surgical wound closure, participants randomized to saline, will receive saline injections along the closure site.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
Bupivacaine hydrochloride (Hospira, Inc) is an FDA approved, local, injectable indicated for the production of local or regional anesthesia or analgesia for surgery.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Normal saline injections.
Primary Outcome Measure Information:
Title
Reported opioid and non-opioid pain medications taken
Description
Patients will report the amount of pain medications taken 3 days immediately following surgery
Time Frame
3 Days Post-Surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandra Onate, M.S.
Phone
312-695-6647
Email
onate@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandra Onate, M.S.
Phone
312-695-6647
Email
onate@northwestern.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery
We'll reach out to this number within 24 hrs