Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction
Recruiting now · Not applicable
Conditions studied: Breast Reconstruction
In brief
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.
Key facts
- Study ID
- NCT07209436
- Run by
- Amy Colwell
- People needed
- 212
- Starts
- 2025-11-19
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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