Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction
Purpose
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.
Condition
- Breast Reconstruction
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Paravertebral Block |
Paravertebral block at preop |
|
|
Experimental Pectoral Block |
Pectoral block at preop |
|
Recruiting Locations
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
More Details
- Status
- Recruiting
- Sponsor
- Amy Colwell