Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction
NCT ID: NCT07209436
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
212 participants
INTERVENTIONAL
2025-12-01
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Paravertebral Block
Paravertebral block at preop
Paravertebral block (single injection)
Paravertebral block at preop
Pectoral Block
Pectoral block at preop
Pectoral block
Pectoral block at preop
Interventions
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Paravertebral block (single injection)
Paravertebral block at preop
Pectoral block
Pectoral block at preop
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Amy Colwell
OTHER
Responsible Party
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Amy Colwell
Sponsor-Investigator
Principal Investigators
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Amy Colwell, M.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Cathleen Huang, D.O.
Role: primary
Other Identifiers
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25-544
Identifier Type: -
Identifier Source: org_study_id