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

NCT07209436 | Recruiting

• 1 other identifier: 25-544
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Reconstruction

Keywords

Breast Reconstruction; Breast cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 Months

Study Arms (2)

Paravertebral Block

ACTIVE COMPARATOR

Paravertebral block at preop

Procedure: Paravertebral block (single injection)

Pectoral Block

EXPERIMENTAL

Pectoral block at preop

Procedure: Pectoral block

Interventions

Paravertebral block (single injection) PROCEDURE

Paravertebral block at preop

Paravertebral Block

Pectoral block PROCEDURE

Pectoral block at preop

Pectoral Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amy Colwell: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Amy Colwell, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathleen Huang, D.O.

CONTACT

617-726-2284; CHUANG24@DFCI.HARVARD.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 7, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)