Phase 4
N=60
Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast Surgery
Surgery · Breast Reconstruction
Bottom Line
View on ClinicalTrials.gov: NCT02905149 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Total Opioid Usage — 18.5; 30 milligrams — p=< 0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Serrato (Procedure); Control (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Usage |
18.5; 30 | < 0.05 sig |
| SECONDARY Pain at Rest and Coughing |
4; 6; 0; 0; 1; 1 | — |
| SECONDARY Time to First Opioid Administration on the Ward |
7.95; 2.9 | — |
| SECONDARY Presence of Opioid Related Complications |
0; 0 | — |
Summary
The purpose of this project is to evaluate the analgesic efficacy of a regional anesthesia technique ( interfascial block at the serratus muscle) performed in patient undergoing breast surgery and the effect of this technique on postoperative analgesia.
Eligibility Criteria
Inclusion Criteria
- Patients older than 18 years, undergoing oncological surgery and/or breast reconstruction surgery whose pathology and surgical intervention supose at least a 24 hours hospital admission
Exclusion Criteria
- ASA Physical Status Classification System- IV.- Morbid obesity (Body mass index >40). -Impossibility of anatomical structures ultrasound identification in a satisfactory way (there can be no distinction in the interfascial plane between serratus and pectoral muscle). -Opioids treatment before surgery. Sepsis and/or infection at the puncture site.
- Haemostasis disorders. - Allergy to any of the drugs used in the study.
Data sourced from ClinicalTrials.gov (NCT02905149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.