Impact of the pain after breast surgery using as local anaesthesia the serratus plane block

Phase 1

Active, not recruiting

Conditions: Patients undergoing oncological surgery and/or breast reconstruction surgery
MedDRA version: 19.0Level: PTClassification code 10042609Term: SurgerySystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2015-005773-21-ES

Lead Sponsor: INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: Not specified

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the use of opioid drugs during breast oncologic surgery and to analyze the efficacy of serratus plane block as a opiates-saving method.;Secondary Objective: Evaluate the degree of post-operative analgesia measured by a visual analogue scale during the first 24 hours after the operation. - Analyze the need of opioid drugs administration in post-operative as a rescue analgesia as well as the time from the surgery until the first dose administered. - Register the appearance of side effects associated with opioids administration and value the correlation of the serratus block in the reduction of such effects frequency. - Value the occurrence of complications related with serratus block as well as the degree of patient satisfaction.;Primary end point(s): Opioids consumption;Timepoint(s) of evaluation of this end point: First 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Postoperative pain measured by EVA (visual analogue scale) in the time. ? Time until the need for rescue analgesia. ? Appearance of postoperative complications (nausea/vomit, itch, apnea, urinary retention, paralytic ileus). ? Gender, age, surgical risk ASA, duration and type of surgery, weight, height, body mass index.;Timepoint(s) of evaluation of this end point: First 24 hours after surgery