Recruiting

Paravertebral vs. Pectoral

Sponsor:

Amy Colwell

Code:

NCT07209436

Conditions

Breast Reconstruction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paravertebral block (single injection)

Pectoral block

Study Details

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

Study ID

NCT07209436

Start date

Nov 19, 2025

Status verified date

Jan, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

212 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Paravertebral Block

Paravertebral block at preop

experimental: Pectoral Block

Pectoral block at preop

Interventions

Paravertebral block (single injection)

Paravertebral block at preop

Pectoral block

Pectoral block at preop

Primary outcome measure

  • Patient-reported physical well-being and breast symptoms [ Time Frame: 12 Months ]
  • Brief Pain Inventory (BPI) Scoring [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Cathleen Huang, D.O.

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Cathleen Huang, D.O.

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

Principal Investigator:

Amy Colwell, M.D.

More Information

Sponsor

Amy Colwell

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Keywords

  • Breast Reconstruction
  • Breast cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amy Colwell on 2026-01-22.