MammaplastyPhase 3NCT05171179
The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery
A Phase 3 study testing Breast Reconstruction (Mammaplasty), Pecs blocks and Exparel in people with Mammaplasty, run by Northwestern University at 1 site in United States.
Trial summary
This project intends to more thoroughly investigate the direct influence of Pecs blocks in the administration of Exparel, a non-opioid analgesic, in breast reconstruction surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammaplasty
- What is being tested?
- Breast Reconstruction (Mammaplasty), Pecs blocks and Exparel
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2021to 1 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects greater than 18 years of age.
- Subject who are undergoing implant-based, tissue expander breast reconstruction surgery.
Who cannot join
- Subjects undergoing flap breast reconstruction.
- Subjects who are undergoing direct-to-implant surgery.
- Subjects who have previously undergone radiation therapy.
- Medical or psychiatric condition that may increase the risk associated with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
- Subjects who are pregnant at the date of surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: A Prospective, Randomized Controlled Trial Investigating Pecs Blocks Types I and II as a Method for Administering the Non-Opioid Anesthetic Exparel in Order to Mitigate Postoperative Narcotic Usage, Pain, Nausea, and Hospital Stay in Patients Undergoing Implant-Based Tissue Expander Breast Reconstruction Surgery
This project intends to more thoroughly investigate the direct influence of Pecs blocks in the administration of Exparel, a non-opioid analgesic, in breast reconstruction surgery. The hypothesis is that this analgesic delivery method will significantly reduce negative outcomes such as post-operative pain, opioid use, and nausea while increasing positive outcomes such as post-operative physical activity.
Read the detailed description
The research team will be investigating the use of a novel type of local drug administration as well as assessing whether a non-opioid based drug will result in more positive pain outcomes while reducing reliance on narcotics (opioid-based drugs) following surgery.
The drug administration tool, called the Pecs blocks types I and II, utilizes ultrasound to help guide anesthetic injection for local anesthesia. This has been an effective way to deliver local anesthetic during breast surgeries. Meanwhile, a non-opioid analgesic drug (similar to an anesthetic, meaning it is used during surgery to reduce pain) called Exparel has been shown to reduce post-operative use of narcotics, length of stay in hospitals, and pain compared to the current standards in breast reconstruction surgery. Exparel is approved by the FDA for use in surgical sites during breast reconstruction surgery. Exparel has shown to reduce pain and post-surgical nausea and vomiting in breast reconstruction patients. However, the combination of Exparel with Pecs blocks has not been examined in breast reconstruction surgery, and the research team suspects that breast reconstruction patients who are administered Exparel with Pecs blocks will experience less pain, increased mobility, and less nausea following surgery. Furthermore, the researchers believe that this non-opioid based drug could reduce the necessity to use narcotics following surgery. Narcotics are highly addictive and can lead to dependency following surgery.
- Conditions
- Mammaplasty
- Being tested
- Breast Reconstruction (Mammaplasty), Pecs blocks, Exparel, Bupivacaine
- Keywords
- breast reconstruction, mammaplasty, analgesic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Reconstruction (Mammaplasty)Procedure or surgery
Breast Reconstruction (mammaplasty) surgery with implant-based tissue expander
Pecs blocksDevice
Also called Pecs blocks I and II
Pectoral nerve (Pecs) blocks I and II function by blocking the pectoral, intercostal, intercostobrachial nerves, and/or long thoracic nerve. These are used primarily for breast surgeries and are gaining momentum as simple administers of local analgesics. Pecs blocks utilize ultrasound to guide injection of local analgesic. It is less invasive and more accurate than most current modes of analgesia administration.
ExparelDrug
Exparel is a sterile, non-pyrogenic white to off-white preservative-free aqueous suspension of multivesicular liposomes (DepoFoam® drug delivery system) containing bupivacaine. Bupivacaine is present at a concentration of 13.3 mg/mL. After injection of Exparel, bupivacaine is released from the multivesicular liposomes over a period of time.
BupivacaineDrug
This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in both arms.
| Study group | Role | What they receive |
|---|---|---|
| Blocks+Bupivacaine | Active comparator | Use of Pecs block types I and II with bupivacaine as local anesthetic Receives: Procedure: Breast Reconstruction (Mammaplasty); Device: Pecs blocks; Drug: Bupivacaine |
| Blocks+Bupivacaine+Exparel | Experimental | Use of Pecs block types I and II with mixture of bupivacaine and Exparel* (*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel) Receives: Procedure: Breast Reconstruction (Mammaplasty); Device: Pecs blocks; Drug: Exparel; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
- Investigate amount of post-operative opioid consumption post operatively
Measured: 2 weeks post op
Secondary outcomes (3)
Nausea
- Assess Post-Operative Nausea scores between the two arms using the participant-recorded Edmonton Symptom Assessment tool which scores on a scale of one to ten, where ten is the most nausea experienced
Measured: 2 weeks post op
Mobility
- Assess post-operative mobility using the participant-recorded Edmonton Symptom Assessment tool which scores on a scale of one to ten where ten is the most immobile
Measured: 2 weeks post op
Pain Outcomes
- Assess the pain patients experience throughout their recovery period using the participant-recorded Edmonton Symptom Assessment tool which scores on a scale of one to ten where ten is the highest pain
Measured: 2 weeks post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start22 Oct 2021
- Primary completion1 May 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammaplastyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Group 1: Use of Pecs block types I and II with bupivacaine as local anesthetic 2. Group 2: Use of Pecs block types I and II with mixture of bupivacaine and Exparel\* (\*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel and in ability to use lidocaine infusion with injection of Exparel)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Principal investigator, Robert Galiano, Northwestern University
- Investigators
- Robert Galiano, MD, Principal investigator, 3126956022
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171179
- Sponsor's protocol ID
- STU00214187
- Status last verified
- Feb 2025
- First submitted
- 4 Nov 2021
- Last updated
- 24 Sep 2025
- 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 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Trial Investigating Pecs Blocks Types I and II as a Method for Administering the Non-Opioid Anesthetic Exparel in Order to Mitigate Postoperative Narcotic Usage, Pain, Nausea, and Hospital Stay in Patients Undergoing Implant-Based Tissue Expander Breast Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT05171179
- Acronym / sponsor ID
- STU00214187
- Conditions
- Mammaplasty
- Keywords
- breast reconstruction, mammaplasty, analgesic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 28 Dec 2021 (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.
This project intends to more thoroughly investigate the direct influence of Pecs blocks in the administration of Exparel, a non-opioid analgesic, in breast reconstruction surgery. The hypothesis is that this analgesic delivery method will significantly reduce negative outcomes such as post-operative pain, opioid use, and nausea while increasing positive outcomes such as post-operative physical activity.
Detailed description
The research team will be investigating the use of a novel type of local drug administration as well as assessing whether a non-opioid based drug will result in more positive pain outcomes while reducing reliance on narcotics (opioid-based drugs) following surgery.
The drug administration tool, called the Pecs blocks types I and II, utilizes ultrasound to help guide anesthetic injection for local anesthesia. This has been an effective way to deliver local anesthetic during breast surgeries. Meanwhile, a non-opioid analgesic drug (similar to an anesthetic, meaning it is used during surgery to reduce pain) called Exparel has been shown to reduce post-operative use of narcotics, length of stay in hospitals, and pain compared to the current standards in breast reconstruction surgery. Exparel is approved by the FDA for use in surgical sites during breast reconstruction surgery. Exparel has shown to reduce pain and post-surgical nausea and vomiting in breast reconstruction patients. However, the combination of Exparel with Pecs blocks has not been examined in breast reconstruction surgery, and the research team suspects that breast reconstruction patients who are administered Exparel with Pecs blocks will experience less pain, increased mobility, and less nausea following surgery. Furthermore, the researchers believe that this non-opioid based drug could reduce the necessity to use narcotics following surgery. Narcotics are highly addictive and can lead to dependency following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 1. Group 1: Use of Pecs block types I and II with bupivacaine as local anesthetic 2. Group 2: Use of Pecs block types I and II with mixture of bupivacaine and Exparel* (*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel and in ability to use lidocaine infusion with injection of Exparel)
| Arm | Type | Receives |
|---|---|---|
| Blocks+Bupivacaine | Active comparator | Procedure: Breast Reconstruction (Mammaplasty), Device: Pecs blocks, Drug: BupivacaineUse of Pecs block types I and II with bupivacaine as local anesthetic |
| Blocks+Bupivacaine+Exparel | Experimental | Procedure: Breast Reconstruction (Mammaplasty), Device: Pecs blocks, Drug: Exparel, Drug: BupivacaineUse of Pecs block types I and II with mixture of bupivacaine and Exparel* (*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects greater than 18 years of age.
- Subject who are undergoing implant-based, tissue expander breast reconstruction surgery.
Key exclusion criteria (5 listed)
- Subjects undergoing flap breast reconstruction.
- Subjects who are undergoing direct-to-implant surgery.
- Subjects who have previously undergone radiation therapy.
- Medical or psychiatric condition that may increase the risk associated with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
- Subjects who are pregnant at the date of surgery.
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 |
|---|---|---|
| Breast Reconstruction (Mammaplasty)Breast Reconstruction (mammaplasty) surgery with implant-based tissue expander | Procedure or surgery | Blocks+Bupivacaine, Blocks+Bupivacaine+Exparel |
| Pecs blocksAlso: Pecs blocks I and IIPectoral nerve (Pecs) blocks I and II function by blocking the pectoral, intercostal, intercostobrachial nerves, and/or long thoracic nerve. These are used primarily for breast surgeries and are gaining momentum as simple administers of local analgesics. Pecs blocks utilize ultrasound to guide injection of local analgesic. It is less invasive and more accurate than most current modes of analgesia administration. | Device | Blocks+Bupivacaine, Blocks+Bupivacaine+Exparel |
| ExparelExparel is a sterile, non-pyrogenic white to off-white preservative-free aqueous suspension of multivesicular liposomes (DepoFoam® drug delivery system) containing bupivacaine. Bupivacaine is present at a concentration of 13.3 mg/mL. After injection of Exparel, bupivacaine is released from the multivesicular liposomes over a period of time. | Drug | Blocks+Bupivacaine+Exparel |
| BupivacaineThis is an anesthetic delivered during breast reconstruction surgery that will be given to participants in both arms. | Drug | Blocks+Bupivacaine, Blocks+Bupivacaine+Exparel |
Primary outcome
Opioid consumption
Time frame: 2 weeks post op
• Investigate amount of post-operative opioid consumption post operatively
3 secondary outcomes
Nausea
Time frame: 2 weeks post op
Mobility
Time frame: 2 weeks post op
Pain Outcomes
Time frame: 2 weeks post op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Robert Galiano, MD principal investigator
3126956022
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Breast Reconstruction (Mammaplasty), Pecs blocks and Exparel in people with Mammaplasty, 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 2 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: finished, as of the sponsor's last update on 24 Sep 2025. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Opioid consumption (time frame: 2 weeks post op). 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 24 Sep 2025.