drugset / Trial / NCT03154658

Serratus Anterior Plane Block in Patients Undergoing Mastectomy

NCT03154658 ↗

Phase 4 Completed 66 enrolled University of Texas Southwestern Medical Center
RandomizedParallel-groupSingle-blindTreatment

Summary

This is a randomized, interventional prospective study. Patients (n=66) undergoing mastectomies with or without tissue expander will be randomized to receive a supra-serratus or sub-serratus regional plane block prior to surgery. The main effect to be measured is total opioid consumption 24 hours after the operation. Secondary endpoints include measuring a change between pre-and post-operative pain scores, patient satisfaction of pain control during first 24 hours after the operation, presence of postoperative nausea and vomiting, duration of sleep on first postoperative night, and block performance time and length of stay, between the two treatment arms.

Timeline

Start
2017-04-01
Primary completion
2020-03-01
Completion
2020-03-01

Outcome

Met primary endpoint

paper Subjects who received a deep SAPB required 30% less oral morphine equivalents (OME) (113.5 mg vs. 147 mg, p = 0.009) PMID 34364099 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ropivacaine Other / unclassified 0.35 % Other
Subject Ropivacaine Other / unclassified 20 ml Other
Subject Ropivacaine Other / unclassified 30 ml Other

Indications