Breast ReconstructionNCT07209436
Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction
A study testing Paravertebral block (single injection) and Pectoral block in people with Breast Reconstruction, run by Amy Colwell at 1 site in United States.
Trial summary
The broad aim of this study is to compare the effectiveness of paravertebral and pectoral blocks on pain and physical well-being of patients undergoing immediate implant-based breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- Paravertebral block (single injection) and Pectoral block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2025to Jun 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient 18 years or older
- Scheduled for unilateral or bilateral immediate implant-based breast reconstruction
- Therapeutic or prophylactic indication
- Patient understands the study procedures and objectives and is willing to participate
- Patient willing to and capable of providing informed consent
Who cannot join
- Delayed breast reconstruction
- Allergy or contraindication to local anesthetics (PVB or PECS blocks)
- History of radiation therapy
- Planned sedation or general anesthesia protocol variation
- Morbid obesity as defined as a BMI greater than 40 kg/m2
- Renal insufficiency
Show all 18Show fewer
- Chronic pain syndrome or central sensitization disorders (e.g., fibromyalgia, CRPS)
- Use of implanted pain devices or neuromodulators
- Pre-existing neurological deficits in the surgical field
- Current chronic opioid use (daily use within the 2 weeks before surgery and duration of use greater than 4 weeks)
- Use of any nerve medications in the past 6 months, including antiepileptic medications (gabapentin, carbamazepine)
- History of drug or alcohol abuse or habitual alcohol intake greater than two standard drinks per day (e.g., two beers, two glasses of wine, or two mixed drinks)
- Any comorbidity that results in moderate or severe functional limitation, inability to communicate with the investigators or hospital staff
- History of a psychiatric disorder which would interfere with the study procedure
- Incarceration
- Any issue that at the discretion of the investigator would contraindicate the subject's participation
- Inability to understand the procedures and objectives of the study
- Inability to or unwilling to provide informed consent
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
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cathleen Huang, D.O., 617-726-2284, CHUANG24@DFCI.HARVARD.EDU
Amy Colwell, M.D.
About this study
The broad aim of this study is to compare the effectiveness of paravertebral and pectoral blocks on pain and physical well-being of patients undergoing immediate implant-based breast reconstruction.
- Conditions
- Breast Reconstruction
- Being tested
- Paravertebral block (single injection), Pectoral block
- Keywords
- Breast Reconstruction, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral block (single injection)Procedure or surgery
Paravertebral block at preop
Pectoral blockProcedure or surgery
Pectoral block at preop
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral Block | Active comparator | Paravertebral block at preop Receives: Procedure: Paravertebral block (single injection) |
| Pectoral Block | Experimental | Pectoral block at preop Receives: Procedure: Pectoral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported physical well-being and breast symptoms
Patient-reported physical well-being and breast symptoms will be evaluated using the Breast Quality of Life Physical Well-Being and Breast Symptoms scales. Values are scores from 0 to 100, with higher scores indicating better satisfaction or quality of life for patients undergoing breast surgery, such as those with breast cancer. These scores are derived from patient-reported outcome measures across different domains like satisfaction with breasts, psychosocial well-being, physical well-being (chest and abdomen), and sexual well-being.
Measured: 12 Months
Brief Pain Inventory (BPI) Scoring
The BPI is a self-report questionnaire that assesses pain intensity and interference. It consists of two parts:
Pain Severity: Measures the intensity of pain using a 0-10 scale, where 0 is "no pain" and 10 is "worst possible pain." Pain Interference: Measures how much pain interferes with daily activities using a 0-10 scale for seven items (e.g., general activity, mood, sleep).
Calculation of Scores:
Pain Severity Score: Add up the scores for the four pain severity questions (worst pain, least pain, average pain, current pain) and divide by 4.
Pain Interference Score: Add up the scores for the seven pain interference questions and divide by 7.
Interpretation:
Pain Severity:
0-3: Mild pain 4-6: Moderate pain 7-10: Severe pain
Pain Interference:
Higher scores indicate greater interference with daily activities.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start19 Nov 2025
- Primary completion30 Jun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amy Colwell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amy Colwell, Massachusetts General Hospital
- Investigators
- Amy Colwell, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209436
- Sponsor's protocol ID
- 25-544
- Status last verified
- Jan 2026
- First submitted
- 1 Oct 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction
- ClinicalTrials.gov ID
- NCT07209436
- Acronym / sponsor ID
- 25-544
- Conditions
- Breast Reconstruction
- Keywords
- Breast Reconstruction, Breast cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Amy ColwellUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 7 Oct 2025 (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 broad aim of this study is to compare the effectiveness of paravertebral and pectoral blocks on pain and physical well-being of patients undergoing immediate implant-based breast reconstruction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral Block | Active comparator | Procedure: Paravertebral block (single injection)Paravertebral block at preop |
| Pectoral Block | Experimental | Procedure: Pectoral blockPectoral block at preop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient 18 years or older
- Scheduled for unilateral or bilateral immediate implant-based breast reconstruction
- Therapeutic or prophylactic indication
- Patient understands the study procedures and objectives and is willing to participate
- Patient willing to and capable of providing informed consent
Key exclusion criteria (18 listed)
- Delayed breast reconstruction
- Allergy or contraindication to local anesthetics (PVB or PECS blocks)
- History of radiation therapy
- Planned sedation or general anesthesia protocol variation
- Morbid obesity as defined as a BMI greater than 40 kg/m2
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 |
|---|---|---|
| Paravertebral block (single injection)Paravertebral block at preop | Procedure or surgery | Paravertebral Block |
| Pectoral blockPectoral block at preop | Procedure or surgery | Pectoral Block |
Primary outcome
Patient-reported physical well-being and breast symptoms
Time frame: 12 Months
Patient-reported physical well-being and breast symptoms will be evaluated using the Breast Quality of Life Physical Well-Being and Breast Symptoms scales. Values are scores from 0 to 100, with higher scores indicating better satisfaction or quality of life for patients undergoing breast surgery, such as those with breast cancer. These scores are derived from patient-reported outcome measures across different domains like satisfaction with breasts, psychosocial well-being, physical well-being (chest and abdomen), and sexual well-being.
Brief Pain Inventory (BPI) Scoring
Time frame: 12 Months
The BPI is a self-report questionnaire that assesses pain intensity and interference. It consists of two parts: Pain Severity: Measures the intensity of pain using a 0-10 scale, where 0 is "no pain" and 10 is "worst possible pain." Pain Interference: Measures how much pain interferes with daily activities using a 0-10 scale for seven items (e.g., general activity, mood, sleep). Calculation of Scores: Pain Severity Score: Add up the scores for the four pain severity questions (worst pain, least pain, average pain, current pain) and divide by 4. Pain Interference Score: Add up the scores for the seven pain interference questions and divide by 7. Interpretation: Pain Severity: 0-3: Mild pain 4-6: Moderate pain 7-10: Severe pain Pain Interference: Higher scores indicate greater interference with daily activities.
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 22 Jan 2026.
- 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.
Amy Colwell, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paravertebral block (single injection) and Pectoral block in people with Breast Reconstruction, run by Amy Colwell 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 5 inclusion and 18 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 22 Jan 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.
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 Cathleen Huang, D.O. (617-726-2284, CHUANG24@DFCI.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported physical well-being and breast symptoms (time frame: 12 Months). 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?
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 22 Jan 2026.