About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Delayed breast reconstruction
Allergy or contraindication to local anesthetics (PVB or PECS blocks)
History of radiation therapy
Planned sedation or general anesthesia protocol variation
Trial design
Parallel
Treatments tested in this trial
Paravertebral block (single injection)
Procedure/SurgeryParavertebral block at preop
Pectoral block
Procedure/SurgeryPectoral block at preop
Treatment groups
Trial outcomes
Primary outcomes
Patient-reported physical well-being and breast symptoms
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
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.
Sponsors and contacts
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Amy Colwell
Lead sponsor
Massachusetts General Hospital
Sponsor institution