NCT02865928

Serratus Plane Block for Postoperative Pain Control

Serratus Plane Block for Postoperative Pain Control After Breast Surgery

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Bupivicaine HCl	Ultrasound guided serratus plane block with bupivicaine
DRUG	Normal Saline	Same injection technique as intervention arm with normal saline

Timeline

• Start date: 2017-09-05
• Primary completion: 2019-11-25
• Completion: 2019-11-25
• First posted: 2016-08-15
• Last updated: 2024-02-22
• Results posted: 2024-02-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study