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

NCT07209436 · Massachusetts General Hospital
In plain English

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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.
Eligibility 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
Study design
Enrollment target: 212 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-19
Estimated completion: 2028-06
Last updated: 2026-01-22
Interventions
Procedure: Paravertebral block (single injection)Procedure: Pectoral block
Primary outcomes
  • Patient-reported physical well-being and breast symptoms (12 Months)
  • Brief Pain Inventory (BPI) Scoring (12 Months)
Sponsor
Amy Colwell · other
Contacts & investigators
ContactCathleen Huang, D.O. · contact · CHUANG24@DFCI.HARVARD.EDU · 617-726-2284
InvestigatorAmy Colwell, M.D. · principal_investigator, Massachusetts General Hospital
All locations (1)
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction · TrialPath