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Pectoral vs. Paravertebral Blocks for Breast Reconstruction Pain

This study is looking at two different ways to manage pain after immediate implant-based breast reconstruction surgery. It compares a "paravertebral block" (a single injection near the spine) with a "pectoral block" (an injection in the chest muscles). The goal is to see which block works better to reduce pain and improve your physical well-being. You might be able to join if you are an adult, 18 years or older, and are scheduled for this type of breast reconstruction. The study will measure your pain and how you feel physically 12 months after your surgery. The current status of this study is unclear, but it plans to enroll 212 participants.

Study design
This is an interventional study comparing two different pain block procedures. It plans to include 212 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your physical well-being and pain will be measured 12 months after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07209436

Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction

Recruiting
NAAges 18+InterventionalSupportive care
Amy Colwell
~212 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:Paravertebral block (single injection)Pectoral block

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient-reported physical well-being and breast symptoms
Measured over 12 Months
+1 more outcome measured

Conditions

Breast Reconstruction

Explore related trials

Breast CarcinomaMammoplasty

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Amy Colwell, M.D. · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Cathleen Huang, D.O.
[email protected]
617-726-2284
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
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

What this trial measures

  • Patient-reported physical well-being and breast symptoms12 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) Scoring12 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.