Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmy Colwell

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Paravertebral block (single injection)

    Procedure/Surgery

    Paravertebral block at preop

  • Pectoral block

    Procedure/Surgery

    Pectoral block at preop

Treatment groups

212 Participants
are divided into 2 treatment groups
Group A: Paravertebral BlockActive comparator 1 intervention
Group B: Pectoral BlockExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amy Colwell

Lead sponsor

Massachusetts General Hospital

Sponsor institution