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

ArmDescriptionAssigned Intervention
Active Comparator
Paravertebral Block 		Paravertebral block at preop
  • Procedure: Paravertebral block (single injection)
    Paravertebral block at preop
Experimental
Pectoral Block 		Pectoral block at preop
  • Procedure: Pectoral block
    Pectoral block at preop

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Cathleen Huang, D.O.
617-726-2284
CHUANG24@DFCI.HARVARD.EDU

More Details

Status
Recruiting
Sponsor
Amy Colwell

Study Contact

Cathleen Huang, D.O.
617-726-2284
CHUANG24@DFCI.HARVARD.EDU