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NCT Number: NCT07209436

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Amy Colwell, M.D.

PRINCIPAL_INVESTIGATOR

Cathleen Huang, D.O.

CONTACT

[email protected]

617-726-2284

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paravertebral block (single injection)

Procedure

Paravertebral block at preop

Pectoral block

Procedure

Pectoral block at preop

Primary outcomes

  1. Patient-reported physical well-being and breast symptoms

    Time frame: 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.

  2. Brief Pain Inventory (BPI) Scoring

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cathleen Huang, D.O.

CONTACT

[email protected]

617-726-2284

Sponsors and collaborators

Lead sponsor

Amy Colwell

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 7, 2025
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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