Pectoral versus paravertebral nerve blocks for pain after immediate implant breast reconstruction
Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction
NA · Massachusetts General Hospital · NCT07209436
This will test whether paravertebral or pectoral nerve blocks better reduce pain and improve physical well-being for adults having immediate implant-based breast reconstruction.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07209436 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for unilateral or bilateral immediate implant-based breast reconstruction at Massachusetts General Hospital will receive either a single-injection paravertebral block or a pectoral (PECS) block before surgery. Pain scores and measures of physical well-being will be collected after surgery to compare the two approaches. Patients with prior radiation, chronic pain syndromes, current chronic opioid use, renal insufficiency, or other listed exclusions are not eligible. The trial aims to identify which regional anesthesia technique provides better postoperative comfort and functional recovery.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for immediate implant-based unilateral or bilateral breast reconstruction who can provide informed consent and meet the eligibility criteria are the ideal candidates.
Not a fit: Patients with delayed reconstruction, prior radiation, chronic pain or central sensitization disorders, current chronic opioid use, or contraindications to local anesthetics are unlikely to be eligible or to benefit from the study interventions.
Why it matters
Potential benefit: If one block provides better pain control and physical well-being, it could reduce postoperative pain, decrease opioid use, and speed recovery for patients.
How similar studies have performed: Regional nerve blocks such as paravertebral and PECS blocks have been shown to reduce postoperative pain after breast surgery, though direct head-to-head data in immediate implant-based reconstruction are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Amy Colwell, M.D. — Massachusetts General Hospital
- Study coordinator: Cathleen Huang, D.O.
- Email: CHUANG24@DFCI.HARVARD.EDU
- Phone: 617-726-2284
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Reconstruction, Breast cancer