Macromastia (Symptomatic)Phase 4NCT07527039
Pectoral Block in Breast Reduction for Pain Control
A Phase 4 study testing Pectoral II Nerve Block and Post Operative Pain Relievers in people with Macromastia (Symptomatic), run by Carilion Clinic at 1 site in United States.
Trial summary
A reduction mammoplasty is a commonly performed procedure for patients with symptomatic macromastia. The procedure involves removing breast parenchyma for an overall reduction in breast size and to alleviate patient symptoms, such as back/neck pain, rashes in the inframammary fold, and bra strap indentation. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Macromastia (Symptomatic)
- What is being tested?
- Pectoral II Nerve Block and Post Operative Pain Relievers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to May 2028
- Phase
- Phase 4
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing breast reduction surgery
- Women older than age 18 and under age 75
- Stable breast size for at least 1 year
- Member has persistent symptoms in at least two of the anatomical body areas below, directly attributed to macromastia and affecting daily activities for at least 1 year:
- Headaches; Pain in neck; Pain in shoulders; Pain in upper back; Painful kyphosis documented by X-rays; Pain/discomfort/ulceration from bra straps cutting into shoulders; Skin breakdown (severe soft tissue infection, tissue necrosis, ulceration hemorrhage) from overlying breast tissue; Upper extremity parasthesia
- Patient has evidence of severe breast hypertrophy that is documented by frontal and side profile photographs
Show all 11Show fewer
- Pain symptoms persist as documented by the physician despite at least a 3-month trial of therapeutic measures such as:
- Analgesic/non-steroidal anti-inflammatory drugs (NSAIDs) interventions and/or muscle relaxants Dermatologic therapy of ulcers, necrosis and refractory infection Physical therapy/exercises/posturing maneuvers Supportive devices (e.g., proper bra support, wide bra straps) Chiropractic care or osteopathic manipulative treatment Medically supervised weight loss program Orthopedic or spine surgeon evaluation of spinal pain
- Breast Reduction is likely to cause a reduction in patient symptoms
- Women 50 years of age or older are required to have a mammogram that was negative for cancer performed within the two years prior to the date of the planned reduction mammoplasty
- Greater than 40 kg in weight
Who cannot join
- History of chronic pain controlled with prescribed narcotics
- English as non-primary language
- No access to email or internet
- Positive pre-surgery pregnancy test
- Women not of ages 18-75
- Less than 40 kg in weight
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, 1 recruiting
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24014
About this study
Official title: Intraoperative Pectoral Block in Breast Reductions: Reduction in Pain Scores & Elimination of Narcotic Use
A reduction mammoplasty is a commonly performed procedure for patients with symptomatic macromastia. The procedure involves removing breast parenchyma for an overall reduction in breast size and to alleviate patient symptoms, such as back/neck pain, rashes in the inframammary fold, and bra strap indentation. It is well documented in the literature that this procedure has a statistically significant reduction in patient symptoms. Postoperatively, it has been within the norm to prescribe narcotics in order to alleviate post-procedural pain. Recently, however, the research realm has advocated a non-narcotic multimodal pain control (MMPC) approach to minimize narcotic usage. Narcotic use is associated with increased costs in the healthcare system due to reported heightened pain scores for extended duration, constipation, nausea, vomiting, opiate dependence among other factors associated with increased morbidity.
The goal of this study is to determine if PECs II (pectoral block type II) block alone is non-inferior to the standard multimodal pain control with narcotics for postoperative pain reduction in breast reduction.
Read the detailed description
Participants will be initially identified and introduced to the study during preoperative breast reduction consultation in the office. Participants will be contacted via phone for the consenting process, and consented electronically, after their consultation. After completion of the consenting and enrollment process, participants will be entered into a software program will automatically randomize participants into a control group (MMPC including narcotics) and an experimental group (PECs II block, MMPC no narcotics). In the experimental group, participants are informed that additional pain control is not withheld and that a paper prescription for a narcotic will be provided. Participants will be informed to use this paper prescription in the event their pain is not adequately controlled in the experimental group. Participants in the control group will have a paper prescription for a narcotic as well to maintain the study's blindness. Participants will be sent surveys at postoperative days 1, 3, and 7 assessing patient pain control as a primary outcome (PROMIS Pain Intensity Survey) and secondary outcomes: narcotic usage and satisfaction level. If participants do not answer initial survey query after 24 hours, a follow up email or phone call will be completed to obtain the information on the following day. Statistical analysis will be performed on the primary outcome assessing non-inferiority between the two groups at all time points once at least 80 patients have enrolled in the study.
Description of PECs II Block: The participant will be administered 20 cc's of local anesthetic (0.25% bupivacaine with epinephrine), with 20 mcg dexmedetomidine and 4 mg dexamethasone added per breast. A total of 40 cc's of 0.25% bupivacaine will be used. This will be performed as a Pectoral II block. "The Pectoral II block is a modified Pectoral I block and can be achieved using a single needle stick. Local anesthetic placement is between the pectoralis major and pectoralis minor as for a Pecs I block and then between pectoralis minor and serratus anterior. The second portion of the procedure will block the anterior cutaneous branches of intercostal nerves 3 to 6, the intercostobrachial nerves, and the long thoracic nerve" (Battista et al). The standard of care injection, whether a nerve block or subcutaneous infiltration typically utilizes only a local anesthetic such as bupivacaine.
Multimodal Pain Regimen: Patients are advised to take 1000 mg of acetaminophen every 6 hours and 600 mg of ibuprofen every 6 hours both scheduled and staggered 3 hours apart. If patient weight <100 kg, oxycodone 5 mg tab PO q6h PRN for pain score 8-10 will be prescribed; disp-10, no refill. If patient weight >100 kg, oxycodone 10 mg tab PO q6h PRN for pain score 8-10 will be prescribed; disp-10, no refill.
- Conditions
- Macromastia (Symptomatic)
- Being tested
- Pectoral II Nerve Block, Post Operative Pain Relievers
- Keywords
- Macromastia, Pectoral nerve block, PEC II block, Opioid reduction postoperatively, breast reduction, reduction mammaplasty
- Medical subject headings
- Gigantomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectoral II Nerve BlockProcedure or surgery
The Pectoral II block is a modified Pectoral I block and can be achieved using a single needle stick. Local anesthetic placement is between the pectoralis major and pectoralis minor as for a Pecs I block and then between pectoralis minor and serratus anterior. The second portion of the procedure will block the anterior cutaneous branches of intercostal nerves 3 to 6, the intercostobrachial nerves, and the long thoracic nerve.
Post Operative Pain RelieversDrug
Participants will receive the same postoperative instructions in both groups. Participants will be instructed to alternate acetaminophen and ibuprofen every 6 hours. Participants will also receive a paper prescription for a narcotic pain medication if pain is not adequately controlled by the over-the-counter products
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients receive wetting solution with lidocaine and epinephrine in both breasts at the beginning of the case for analgesia and hemostasis. No nerve block is administered intraoperatively. As needed narcotic paper prescription is provided, same as in the experimental group. Receives: Drug: Post Operative Pain Relievers |
| PEC II block group | Experimental | Patients receive wetting solution with only epinephrine in both breasts at the beginning of the case for hemostasis. The patient will be administered 20 cc's of local anesthetic (0.25% bupivacaine with epinephrine), with 20 mcg dexmedetomidine and 4 mg dexamethasone added per breast. A total of 40 cc's of 0.25% bupivacaine will be used. This will be performed as a Pectoral II block. As needed narcotic paper prescription is provided, same as in the control group. Receives: Procedure: Pectoral II Nerve Block; Drug: Post Operative Pain Relievers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain control regimen
Participants are administered postoperative surveys on days 1, 3, and 7. These surveys assess type of analgesic medication usage and frequency. The primary purpose is to assess narcotic usage between the two groups to observe a reduction or elimination in narcotic usage in the control group
Measured: From enrollment to completion of the study is approximately 3 weeks
Postoperative PROMIS pain intensity survey
Participants are administered a postoperative survey on days 1, 3, and 7. This survey asks participants to rate their pain at its worst, the average intensity level, and the level of pain intensity while taking the survey. This is a numbered survey from 1-5 with 1=no pain, 2=mild, 3=moderate, 4=severe, and 5= very severe
Measured: Surveys collected on days 1, 3, and 7 post-surgery. From enrollment to completion of the study is approximately 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Apr 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Macromastia (Symptomatic)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be initially identified and introduced to the study in their preoperative breast reduction consultation in the office. Patients will be contacted via phone for the consenting process, which they will have a virtual copy of their consent, after their consultation. After completion of the consenting and enrollment process, they will be entered into REDCap and the software will automatically randomize participants into a control group (MMPC including narcotics) and an experimental group (PECs II block, MMPC no narcotics). In the experimental group, patients are informed that additional pain control is not withheld and that a paper prescription for a narcotic will be provided. Patients will be informed to use this paper prescription in the event their pain is not adequately controlled in the experimental group. Patients in the control group will have a paper prescription for a narcotic as well to maintain the study's blindness.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Capito, MD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527039
- Sponsor's protocol ID
- IRB-23-2101
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang K, Zhang X, Zhang T, Yue H, Sun S, Zhao H, Zhou P. The Efficacy of Ultrasound-guided Type II Pectoral Nerve Blocks in Perioperative Pain Management for Immediate Reconstruction After Modified Radical Mastectomy: A Prospective, Randomized Study. Clin J Pain. 2018 Mar;34(3):231-236. doi: 10.1097/AJP.0000000000000529.
PubMed 28654558Sercan O, Karaveli A, Ozmen S, Uslu A. Comparison of the Effects of Pectoral Nerve Block and Local Infiltration Anesthesia on Postoperative Pain for Breast Reduction Surgery: A Prospective Observational Study. Eurasian J Med. 2021 Jun;53(2):102-107. doi: 10.5152/eurasianjmed.2021.20111.
PubMed 34177291Nguyen, Minh MD; Bhardwaj, Priya MD; Goulart, Micheline MD; Huayllani, Maria T. MD; Arredondo, Sean MD; Mitchell, Kerry-Ann S. MD, PhD; Lehrman, Craig R. MD. Effectiveness of Pectoral Nerve Block in Breast Reduction: A Single Institution Experience. Plastic and Reconstructive Surgery - Global Open 10(10S):p 58, October 2022. | DOI: 10.1097/01.GOX.0000898612.51965.a1
Aarab Y, Ramin S, Odonnat T, Garnier O, Boissin A, Molinari N, Marin G, Perrigault PF, Cuvillon P, Chanques G. Pectoral Nerve Blocks for Breast Augmentation Surgery: A Randomized, Double-blind, Dual-centered Controlled Trial. Anesthesiology. 2021 Sep 1;135(3):442-453. doi: 10.1097/ALN.0000000000003855.
PubMed 34195767Yesiltas S, Turkoz A, Calim M, Yilmaz S, Esen A, Daskaya H, Karaaslan K. Comparison of serratus plane block alone and in combination with pectoral type 1 block for breast cancer surgery: a randomized controlled study. Hippokratia. 2021 Jan-Mar;25(1):8-14.
PubMed 35221650Taylor GA, Panichella JC, Neusner A, Lo A, Vazquez D, Zhao H, Trehan G, Livelsberger J, Gassman AA. Pain Control after Reduction Mammaplasty with Combination Bupivacaine and Dexamethasone Regional Block: A Randomized Controlled Trial. Plast Reconstr Surg. 2023 Aug 1;152(2):217e-226e. doi: 10.1097/PRS.0000000000010198. Epub 2023 Jul 27.
PubMed 36728270Choi JB, Shim YH, Lee YW, Lee JS, Choi JR, Chang CH. Incidence and risk factors of postoperative nausea and vomiting in patients with fentanyl-based intravenous patient-controlled analgesia and single antiemetic prophylaxis. Yonsei Med J. 2014 Sep;55(5):1430-5. doi: 10.3349/ymj.2014.55.5.1430.
PubMed 25048507Santosa KB, Lai YL, Brummett CM, Oliver JD, Hu HM, Englesbe MJ, Blair EM, Waljee JF. Higher Amounts of Opioids Filled After Surgery Increase Risk of Serious Falls and Fall-Related Injuries Among Older Adults. J Gen Intern Med. 2020 Oct;35(10):2917-2924. doi: 10.1007/s11606-020-06015-6. Epub 2020 Aug 3.
PubMed 32748343
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Pectoral Block in Breast Reductions: Reduction in Pain Scores & Elimination of Narcotic Use
- ClinicalTrials.gov ID
- NCT07527039
- Acronym / sponsor ID
- IRB-23-2101
- Conditions
- Macromastia (Symptomatic)
- Keywords
- Macromastia, Pectoral nerve block, PEC II block, Opioid reduction postoperatively, breast reduction, reduction mammaplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 14 Apr 2026 (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.
A reduction mammoplasty is a commonly performed procedure for patients with symptomatic macromastia. The procedure involves removing breast parenchyma for an overall reduction in breast size and to alleviate patient symptoms, such as back/neck pain, rashes in the inframammary fold, and bra strap indentation. It is well documented in the literature that this procedure has a statistically significant reduction in patient symptoms. Postoperatively, it has been within the norm to prescribe narcotics in order to alleviate post-procedural pain. Recently, however, the research realm has advocated a non-narcotic multimodal pain control (MMPC) approach to minimize narcotic usage. Narcotic use is associated with increased costs in the healthcare system due to reported heightened pain scores for extended duration, constipation, nausea, vomiting, opiate dependence among other factors associated with increased morbidity.
The goal of this study is to determine if PECs II (pectoral block type II) block alone is non-inferior to the standard multimodal pain control with narcotics for postoperative pain reduction in breast reduction.
Detailed description
Participants will be initially identified and introduced to the study during preoperative breast reduction consultation in the office. Participants will be contacted via phone for the consenting process, and consented electronically, after their consultation. After completion of the consenting and enrollment process, participants will be entered into a software program will automatically randomize participants into a control group (MMPC including narcotics) and an experimental group (PECs II block, MMPC no narcotics). In the experimental group, participants are informed that additional pain control is not withheld and that a paper prescription for a narcotic will be provided. Participants will be informed to use this paper prescription in the event their pain is not adequately controlled in the experimental group. Participants in the control group will have a paper prescription for a narcotic as well to maintain the study's blindness. Participants will be sent surveys at postoperative days 1, 3, and 7 assessing patient pain control as a primary outcome (PROMIS Pain Intensity Survey) and secondary outcomes: narcotic usage and satisfaction level. If participants do not answer initial survey query after 24 hours, a follow up email or phone call will be completed to obtain the information on the following day. Statistical analysis will be performed on the primary outcome assessing non-inferiority between the two groups at all time points once at least 80 patients have enrolled in the study.
Description of PECs II Block: The participant will be administered 20 cc's of local anesthetic (0.25% bupivacaine with epinephrine), with 20 mcg dexmedetomidine and 4 mg dexamethasone added per breast. A total of 40 cc's of 0.25% bupivacaine will be used. This will be performed as a Pectoral II block. "The Pectoral II block is a modified Pectoral I block and can be achieved using a single needle stick. Local anesthetic placement is between the pectoralis major and pectoralis minor as for a Pecs I block and then between pectoralis minor and serratus anterior. The second portion of the procedure will block the anterior cutaneous branches of intercostal nerves 3 to 6, the intercostobrachial nerves, and the long thoracic nerve" (Battista et al). The standard of care injection, whether a nerve block or subcutaneous infiltration typically utilizes only a local anesthetic such as bupivacaine.
Multimodal Pain Regimen: Patients are advised to take 1000 mg of acetaminophen every 6 hours and 600 mg of ibuprofen every 6 hours both scheduled and staggered 3 hours apart. If patient weight <100 kg, oxycodone 5 mg tab PO q6h PRN for pain score 8-10 will be prescribed; disp-10, no refill. If patient weight >100 kg, oxycodone 10 mg tab PO q6h PRN for pain score 8-10 will be prescribed; disp-10, no refill.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be initially identified and introduced to the study in their preoperative breast reduction consultation in the office. Patients will be contacted via phone for the consenting process, which they will have a virtual copy of their consent, after their consultation. After completion of the consenting and enrollment process, they will be entered into REDCap and the software will automatically randomize participants into a control group (MMPC including narcotics) and an experimental group (PECs II block, MMPC no narcotics). In the experimental group, patients are informed that additional pain control is not withheld and that a paper prescription for a narcotic will be provided. Patients will be informed to use this paper prescription in the event their pain is not adequately controlled in the experimental group. Patients in the control group will have a paper prescription for a narcotic as well to maintain the study's blindness.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Post Operative Pain RelieversPatients receive wetting solution with lidocaine and epinephrine in both breasts at the beginning of the case for analgesia and hemostasis. No nerve block is administered intraoperatively. As needed narcotic paper prescription is provided, same as in the experimental group. |
| PEC II block group | Experimental | Procedure: Pectoral II Nerve Block, Drug: Post Operative Pain RelieversPatients receive wetting solution with only epinephrine in both breasts at the beginning of the case for hemostasis. The patient will be administered 20 cc's of local anesthetic (0.25% bupivacaine with epinephrine), with 20 mcg dexmedetomidine and 4 mg dexamethasone added per breast. A total of 40 cc's of 0.25% bupivacaine will be used. This will be performed as a Pectoral II block. As needed narcotic paper prescription is provided, same as in the control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Undergoing breast reduction surgery
- Women older than age 18 and under age 75
- Stable breast size for at least 1 year
- Member has persistent symptoms in at least two of the anatomical body areas below, directly attributed to macromastia and affecting daily activities for at least 1 year:
- Headaches; Pain in neck; Pain in shoulders; Pain in upper back; Painful kyphosis documented by X-rays; Pain/discomfort/ulceration from bra straps cutting into shoulders; Skin breakdown (severe soft tissue infection, tissue necrosis, ulceration hemorrhage) from overlying breast tissue; Upper extremity parasthesia
Key exclusion criteria (6 listed)
- History of chronic pain controlled with prescribed narcotics
- English as non-primary language
- No access to email or internet
- Positive pre-surgery pregnancy test
- Women not of ages 18-75
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 |
|---|---|---|
| Pectoral II Nerve BlockThe Pectoral II block is a modified Pectoral I block and can be achieved using a single needle stick. Local anesthetic placement is between the pectoralis major and pectoralis minor as for a Pecs I block and then between pectoralis minor and serratus anterior. The second portion of the procedure will block the anterior cutaneous branches of intercostal nerves 3 to 6, the intercostobrachial nerves, and the long thoracic nerve. | Procedure or surgery | PEC II block group |
| Post Operative Pain RelieversParticipants will receive the same postoperative instructions in both groups. Participants will be instructed to alternate acetaminophen and ibuprofen every 6 hours. Participants will also receive a paper prescription for a narcotic pain medication if pain is not adequately controlled by the over-the-counter products | Drug | Control group, PEC II block group |
Primary outcome
Postoperative pain control regimen
Time frame: From enrollment to completion of the study is approximately 3 weeks
Participants are administered postoperative surveys on days 1, 3, and 7. These surveys assess type of analgesic medication usage and frequency. The primary purpose is to assess narcotic usage between the two groups to observe a reduction or elimination in narcotic usage in the control group
Postoperative PROMIS pain intensity survey
Time frame: Surveys collected on days 1, 3, and 7 post-surgery. From enrollment to completion of the study is approximately 3 weeks
Participants are administered a postoperative survey on days 1, 3, and 7. This survey asks participants to rate their pain at its worst, the average intensity level, and the level of pain intensity while taking the survey. This is a numbered survey from 1-5 with 1=no pain, 2=mild, 3=moderate, 4=severe, and 5= very severe
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 14 Apr 2026.
- Background: PubMed 28654558Wang K, Zhang X, Zhang T, Yue H, Sun S, Zhao H, Zhou P. The Efficacy of Ultrasound-guided Type II Pectoral Nerve Blocks in Perioperative Pain Management for Immediate Reconstruction After Modified Radical Mastectomy: A Prospective, Randomized Study. Clin J Pain. 2018 Mar;34(3):231-236. doi: 10.1097/AJP.0000000000000529.
- Background: PubMed 34177291Sercan O, Karaveli A, Ozmen S, Uslu A. Comparison of the Effects of Pectoral Nerve Block and Local Infiltration Anesthesia on Postoperative Pain for Breast Reduction Surgery: A Prospective Observational Study. Eurasian J Med. 2021 Jun;53(2):102-107. doi: 10.5152/eurasianjmed.2021.20111.
- BackgroundNguyen, Minh MD; Bhardwaj, Priya MD; Goulart, Micheline MD; Huayllani, Maria T. MD; Arredondo, Sean MD; Mitchell, Kerry-Ann S. MD, PhD; Lehrman, Craig R. MD. Effectiveness of Pectoral Nerve Block in Breast Reduction: A Single Institution Experience. Plastic and Reconstructive Surgery - Global Open 10(10S):p 58, October 2022. | DOI: 10.1097/01.GOX.0000898612.51965.a1
- Background: PubMed 34195767Aarab Y, Ramin S, Odonnat T, Garnier O, Boissin A, Molinari N, Marin G, Perrigault PF, Cuvillon P, Chanques G. Pectoral Nerve Blocks for Breast Augmentation Surgery: A Randomized, Double-blind, Dual-centered Controlled Trial. Anesthesiology. 2021 Sep 1;135(3):442-453. doi: 10.1097/ALN.0000000000003855.
- Background: PubMed 35221650Yesiltas S, Turkoz A, Calim M, Yilmaz S, Esen A, Daskaya H, Karaaslan K. Comparison of serratus plane block alone and in combination with pectoral type 1 block for breast cancer surgery: a randomized controlled study. Hippokratia. 2021 Jan-Mar;25(1):8-14.
- Background: PubMed 36728270Taylor GA, Panichella JC, Neusner A, Lo A, Vazquez D, Zhao H, Trehan G, Livelsberger J, Gassman AA. Pain Control after Reduction Mammaplasty with Combination Bupivacaine and Dexamethasone Regional Block: A Randomized Controlled Trial. Plast Reconstr Surg. 2023 Aug 1;152(2):217e-226e. doi: 10.1097/PRS.0000000000010198. Epub 2023 Jul 27.
- Background: PubMed 25048507Choi JB, Shim YH, Lee YW, Lee JS, Choi JR, Chang CH. Incidence and risk factors of postoperative nausea and vomiting in patients with fentanyl-based intravenous patient-controlled analgesia and single antiemetic prophylaxis. Yonsei Med J. 2014 Sep;55(5):1430-5. doi: 10.3349/ymj.2014.55.5.1430.
- Background: PubMed 32748343Santosa KB, Lai YL, Brummett CM, Oliver JD, Hu HM, Englesbe MJ, Blair EM, Waljee JF. Higher Amounts of Opioids Filled After Surgery Increase Risk of Serious Falls and Fall-Related Injuries Among Older Adults. J Gen Intern Med. 2020 Oct;35(10):2917-2924. doi: 10.1007/s11606-020-06015-6. Epub 2020 Aug 3.
- Individual participant dataSharing planned: No
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.
Anthony Capito, MD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pectoral II Nerve Block and Post Operative Pain Relievers in people with Macromastia (Symptomatic), run by Carilion Clinic 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 11 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 Apr 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Patrick Dugom, MD (540-655-8133, pmdugom@carilionclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain control regimen (time frame: From enrollment to completion of the study is approximately 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07527039, which also lists 8 linked publications.
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 14 Apr 2026.