Clinical trial NCT02865928: Serratus Plane Block for Postoperative Pain Control
Official title: Serratus Plane Block for Postoperative Pain Control After Breast Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Outpatient Breast Surgery
Mastopexy
Augmentation
Revision
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative Opioid Requirements
timeFrame: 4 to 10 hours
Secondary outcomes:
measure: Postoperative Pain With Numeric Rating Scale
timeFrame: every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours.
measure: Postoperative Nausea and Vomiting With Verbal Rating Scale
timeFrame: every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours.
measure: Number of Participants Who Required Antiemetics During the Postoperative Period.
timeFrame: 4 to 10 hours
measure: PACU Length of Stay
timeFrame: 0 to 10 hours
measure: Patient Experience and Satisfaction With a 5-point Categorial Scale
timeFrame: 1 week
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Northwell Health System
state: New York
Study officials:
affiliation: Northwell Health
name: Judith Aronsohn, MD
role: PRINCIPAL_INVESTIGATOR
References: