An interventional study of Paravertebral block (single injection) and Pectoral block in Breast Reconstruction, sponsored by Amy Colwell. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Amy Colwell · Not applicable, Interventional, and Supportive care
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 212 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Amy Colwell as lead sponsor.
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Exclusion Criteria:
Paravertebral block at preop
Procedure: Paravertebral block (single injection)
Pectoral block at preop
Procedure: Pectoral block
Paravertebral block at preop
Pectoral block at preop
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.
Time frame: 12 Months
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.
Time frame: 12 Months
Plan to share: No
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