Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast Surgery

NCT02905149 | Completed Phase 4 Results

• 1 other identifier: IBMS-SPB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery; Breast Reconstruction

Keywords

Oncological; Surgery; Breast; Reconstruction

Outcome Measures

Primary Outcomes (1)

• Total Opioid Usage

  Total opioid usage in the first 24 hours (intra and postoperative) (in morphine milligrmas, fentanyl/morphine conversion = 10 mcgs/1mg). Opioid used will be fentanyl and morphine. Fentanyl will be converted in morphine milligrams equivlents to caluclate the total first 24H dose.

  First 24 hours after surgery

Secondary Outcomes (3)

• Pain at Rest and Coughing

  First 24 hours after surgery

• Time to First Opioid Administration on the Ward

  First 24 hours after surgery

• Presence of Opioid Related Complications

  First 24 hours after surgery

Study Arms (2)

Serrato

EXPERIMENTAL

Standard anesthesia+serratus plane block.

Procedure: Serrato

Control

PLACEBO COMPARATOR

Standard anesthesia

Procedure: Control

Interventions

Serrato PROCEDURE

Serratus plane block.

Serrato

Control PROCEDURE

Standard anesthesia

Control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (1)

Hospital de Manises

Manises, Valencia, 46940, Spain

Location

Related Publications (1)

• Mazzinari G, Rovira L, Casasempere A, Ortega J, Cort L, Esparza-Minana JM, Belaouchi M. Interfascial block at the serratus muscle plane versus conventional analgesia in breast surgery: a randomized controlled trial. Reg Anesth Pain Med. 2019 Jan;44(1):52-58. doi: 10.1136/rapm-2018-000004.

  PMID: 30640653 DERIVED

Limitations and Caveats

The blinding method cannot entirely exclude ascertainment bias.

Results Point of Contact

• Title: Maria Cortell
• Organization: Instituto de Investigación Sanitaria La Fe

investigacion_clinica@iislafe.es

961246611

Study Officials

• Guido Mazzinari

  Instituto de Investigación Sanitaria La Fe

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two group parallel arm. With study group receiving regional anesthestic block with levobupivacaine and control group receiving standard care with intravenous analgesia only

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: August 2, 2016
• Primary Completion: June 8, 2017
• Study Completion: July 8, 2017
• Last Updated: March 2, 2020
• Results First Posted: March 2, 2020

Record last verified: 2017-08

Locations

ES (1)