๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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
๐
What it tests
- Paravertebral block (single injection)
- Pectoral block
Massachusetts General Hospital
Boston, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.