Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 212
- Locations
- 1
- Primary Endpoint
- Patient-reported physical well-being and breast symptoms
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- 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
Arms & Interventions
Paravertebral Block
Paravertebral block at preop
Intervention: Paravertebral block (single injection) (Procedure)
Pectoral Block
Pectoral block at preop
Intervention: Pectoral block (Procedure)
Outcomes
Primary Outcomes
Patient-reported physical well-being and breast symptoms
Time Frame: 12 Months
Patient-reported physical well-being and breast symptoms will be evaluated using the Breast Quality of Life Physical Well-Being and Breast Symptoms scales. Values are scores from 0 to 100, with higher scores indicating better satisfaction or quality of life for patients undergoing breast surgery, such as those with breast cancer. These scores are derived from patient-reported outcome measures across different domains like satisfaction with breasts, psychosocial well-being, physical well-being (chest and abdomen), and sexual well-being.
Brief Pain Inventory (BPI) Scoring
Time Frame: 12 Months
The BPI is a self-report questionnaire that assesses pain intensity and interference. It consists of two parts: Pain Severity: Measures the intensity of pain using a 0-10 scale, where 0 is "no pain" and 10 is "worst possible pain." Pain Interference: Measures how much pain interferes with daily activities using a 0-10 scale for seven items (e.g., general activity, mood, sleep). Calculation of Scores: Pain Severity Score: Add up the scores for the four pain severity questions (worst pain, least pain, average pain, current pain) and divide by 4. Pain Interference Score: Add up the scores for the seven pain interference questions and divide by 7. Interpretation: Pain Severity: 0-3: Mild pain 4-6: Moderate pain 7-10: Severe pain Pain Interference: Higher scores indicate greater interference with daily activities.
Secondary Outcomes
No secondary outcomes reported
Investigators
Amy Colwell
Sponsor-Investigator
Massachusetts General Hospital