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

Impact of the serratus plane block in pain and the use of opioids in breast surgery - Serratus plane block in breast surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005773-21-ES

Enrollment

Unknown

Registered

2016-04-21

Start date

2016-05-10

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing oncological surgery and/or breast reconstruction surgery MedDRA version: 19.0 Level: PT Classification code 10042609 Term: Surgery System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: LEVOBUPIVACAINA Pharmaceutical Form: Solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion 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 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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Spain

Contacts

Public ContactUREC

INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE

investigacion_clinica@iislafe.es34961246611

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026