Serratus Plane Block for Postoperative Pain Control

NCT02865928 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 15-246
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Outpatient Breast Surgery; Mastopexy; Augmentation; Revision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative Pain With Numeric Rating Scale

  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

  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.

  4 to 10 hours

• PACU Length of Stay

  0 to 10 hours

• Patient Experience and Satisfaction With a 5-point Categorial Scale

  1 week

Study Arms (2)

Bupivicaine HCl

EXPERIMENTAL

Ultrasound guided serratus plane block with bupivacaine HCl.

Drug: Bupivicaine HCl

Normal Saline

PLACEBO COMPARATOR

Placebo injection on operated side, same technique as experimental group.

Drug: Normal Saline

Interventions

Bupivicaine HCl DRUG

Ultrasound guided serratus plane block with bupivicaine

Also known as: Bupivicaine

Bupivicaine HCl

Normal Saline DRUG

Same injection technique as intervention arm with normal saline

Also known as: 0.09% NaCl

Normal Saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health System

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Louis Ballas
• Organization: Northwell Health

lballas@northwell.edu

718-470-5827

Study Officials

• Judith Aronsohn, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: August 15, 2016
• Study Start: September 5, 2017
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: February 22, 2024
• Results First Posted: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)