Breast Reconstruction
Conditions
Keywords
Breast Reconstruction, Breast cancer
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.
Interventions
Paravertebral block at preop
PROCEDUREPectoral block
Pectoral block at preop
Sponsors
Amy Colwell
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported physical well-being and breast symptoms | 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 | 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. |
Countries
United States
Contacts
CONTACTCathleen Huang, D.O.
PRINCIPAL_INVESTIGATORAmy Colwell, M.D.
Massachusetts General Hospital
Outcome results
None listed