Pectoral versus paravertebral nerve blocks for pain after immediate implant breast reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.