Pain, PostoperativePhase 1NCT04260854
Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery
A Phase 1 study testing Bupivacaine Hydrochloride and Saline in people with Pain, Postoperative, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Bupivacaine Hydrochloride and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2024to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years of age
- Receiving cutaneous surgery
- In good general health as assessed by the investigator
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Locally Administered Bupivacaine Hydrochloride for Post-operative Pain Control in Cutaneous Surgery: A Randomized Controlled Trial
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.
- Conditions
- Pain, Postoperative
- Being tested
- Bupivacaine Hydrochloride, Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
Bupivacaine hydrochloride (Hospira, Inc) is an FDA approved, local, injectable indicated for the production of local or regional anesthesia or analgesia for surgery.
SalineDrug
Normal saline injections.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine HCl | Active comparator | Immediately prior to surgical wound closure, participants randomized to the bupivacaine arm will be injected with bupivacaine HCl along the closure site. Receives: Drug: Bupivacaine Hydrochloride |
| Saline | Placebo comparator | Immediately prior to surgical wound closure, participants randomized to saline, will receive saline injections along the closure site. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported opioid and non-opioid pain medications taken
Patients will report the amount of pain medications taken 3 days immediately following surgery
Measured: 3 Days Post-Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start24 Jan 2024
- Primary completion20 May 2026
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260854
- Sponsor's protocol ID
- STU00211424
- Status last verified
- May 2026
- First submitted
- 6 Feb 2020
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locally Administered Bupivacaine Hydrochloride for Post-operative Pain Control in Cutaneous Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04260854
- Acronym / sponsor ID
- STU00211424
- Conditions
- Pain, Postoperative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine HCl | Active comparator | Drug: Bupivacaine HydrochlorideImmediately prior to surgical wound closure, participants randomized to the bupivacaine arm will be injected with bupivacaine HCl along the closure site. |
| Saline | Placebo comparator | Drug: SalineImmediately prior to surgical wound closure, participants randomized to saline, will receive saline injections along the closure site. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years of age
- Receiving cutaneous surgery
- In good general health as assessed by the investigator
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine HydrochlorideBupivacaine hydrochloride (Hospira, Inc) is an FDA approved, local, injectable indicated for the production of local or regional anesthesia or analgesia for surgery. | Drug | Bupivacaine HCl |
| SalineNormal saline injections. | Drug | Saline |
Primary outcome
Reported opioid and non-opioid pain medications taken
Time frame: 3 Days Post-Surgery
Patients will report the amount of pain medications taken 3 days immediately following surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupivacaine Hydrochloride and Saline in people with Pain, Postoperative, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reported opioid and non-opioid pain medications taken (time frame: 3 Days Post-Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.