Serratus Plane Block for Postoperative Pain Control

Serratus Plane Block for Postoperative Pain Control After Breast Surgery

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

Study Overview

• Status: Terminated
• Conditions: Augmentation; Revision; Mastopexy; Outpatient Breast Surgery
• Intervention / Treatment: Drug: Bupivicaine HCl; Drug: Normal Saline

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Oonagh Dowling, PhD; Phone Number: 718-470-7630; Email: odowling@northwell.edu

Study Locations

• United States
  • New York
    • New Hyde Park, New York, United States, 11040
      • Northwell Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupivicaine HCl; Ultrasound guided serratus plane block with bupivacaine HCl.	Drug: Bupivicaine HCl; Ultrasound guided serratus plane block with bupivicaine; Other Names: Bupivicaine
Placebo Comparator: Normal Saline; Placebo injection on operated side, same technique as experimental group.	Drug: Normal Saline; Same injection technique as intervention arm with normal saline; Other Names: 0.09% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Opioid Requirements	Postoperatively, oral and IV rescue medication will be administered to both groups upon request as per standard of care. The use of narcotics will also be recorded intra-operatively, for the duration of PACU and hospital stay and up until the end of postoperative day one. Consumption of rescue medication will be converted to the morphine equivalent (ME) dose for analysis.	4 to 10 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain With Numeric Rating Scale	Postoperatively, pain intensities at rest and on movement will be assessed every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, using the visual analog scale (VAS) with two anchor points; 0 being no pain and 10 being the worst pain imaginable. Pain scores were combined to find the mean and standard deviation.; The study will collect pain and scores in the PACU every 30 minutes up to 4 hrs and at 1 hr intervals after 4 hours for the duration of PACU stay.	every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours.
Postoperative Nausea and Vomiting With Verbal Rating Scale	Nausea assessed at time intervals with numeric rating scale and episodes of vomiting and retching recorded.; Evaluation will be performed at every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge using a standard 11-point verbal rating scale, for which "0" represents "no nausea" and 10 represents "worst nausea imaginable." Nausea and vomiting scores were combined to find the mean and standard deviation.; The study will collect nausea and scores in the PACU every 30 minutes up to 4 hrs and at 1 hr intervals after 4 hours for the duration of PACU stay.	every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours.
Number of Participants Who Required Antiemetics During the Postoperative Period.	Number of Participants who Required Antiemetics During the Postoperative Period.	4 to 10 hours
PACU Length of Stay	Time to PACU discharge	0 to 10 hours
Patient Experience and Satisfaction With a 5-point Categorial Scale	This survey assessed patient experience and satisfaction. The scale ranged from "Very dissatisfied" or "1" was the minimum value. "Very satisfied" or "5" was the maximum value.	1 week

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Judith Aronsohn, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Actual): November 25, 2019
• Study Completion (Actual): November 25, 2019

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimated): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 15-246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes