Serratus Plane Block for Postoperative Pain Control After Breast Surgery

15-246

This is a randomized, double-blinded, placebo-controlled trial of serratus plane blocks in subjects undergoing outpatient unilateral or bilateral breast surgery. Ninety subjects will be enrolled into the study at presurgical testing. Subjects will be stratified based on surgery type and randomized to receive a serratus plane block with either bupivicaine HCL or placebo. All patients will receive standard intraoperative anesthesia and standard postoperative pain control. The primary endpoint is the amount of opioid administered postoperatively. Secondary endpoints include postoperative pain intensity at timed intervals, amount of opioid administered intraoperatively and postoperatively, incidence of nausea and vomiting, time to discharge and patient satisfaction

2017-09-05

2019-11-25

2019-11-25

Terminated

Early phase I

42

Inclusion Criteria: * ASA I-III. * Undergoing outpatient breast surgery requiring general anesthesia, including but not limited to mastectomy, lumpectomy, reconstruction with tissue expanders or implants and reconstruction revision. Exclusion Criteria: * Unable to provide informed consent. * Patients who are pregnant or nursing. * ASA IV-V. * Alcohol or narcotic dependence in the last 2 years. * Concurrent condition requiring regular use of analgesia that may confound post-surgical assessments as determined by principle investigator. * Hepatic disease. * Allergies to amide anesthetics as determined from medical history or patient self-report. * Evidence of infection at injection site. * Contraindication to pain medications such as acetominophen, morphine, oxycodone, keterolac, dilaudid, Toradol. * Body weight \<50kg. * BMI\>40kg/m2. * History of hypotension. * Abnormal renal (creatinine \> 1.5 mg/dL) function. * Heart block. * Any physical, mental or medical condition, that in the opinion of the investigator, makes study participation inadvisable.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 42, 'type': 'ACTUAL'}}

2024-02-22