Trial NCT07209436
Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction
- Phase
- Not given
- Sponsor
- Amy Colwell
- Conditions
- Breast Reconstruction
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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/m2BMI
* Renal insufficiencyRenal
* 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
Restrictions found (2)
- BMIOutrightexclusion
BMI > 40 kg/m2
Show in the text - RenalOutrightexclusionShow in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County