PVB vs PECS Block in Breast Surgery

Not Applicable

Completed

• Conditions: Reconstruction Breast Surgery
• Interventions: Procedure: Paravertebral Thoracic block; Procedure: Pectorals nerve block; Drug: Levobupivacaine 0.25%; Drug: Morphine

• Registration Number: NCT02677571
• Lead Sponsor: Istituti Ospitalieri di Cremona

Brief Summary

Purpose to compare paravertebral thoracic block (PVB) and pectorals nerves block as analgesic option for major breast surgery.

102 patients undergoing reconstruction breast surgery will be randomized into two groups: Group PVB (n=51) will receive US guided paravertebral thoracic block (between T2-T6) performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction.

Morphine patient control analgesia (PCA) with loading dose i.v. titrated by the PACU nurse if pain \> 5/10 at rest Group PECS (n=51) will receive US guided pectorals nerves block performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction.

Morphine PCA with loading dose i.v. titrated by the post-anesthesia care unit (PACU) nurse if pain \> 5/10 at rest

Primary Outcome Measures:

Morphine consumption (mg) (Time Frame: 24 hours) in two Groups

Secondary Outcome Measures:

Pain at rest and during movement quantified as Numerical Rating Scores (0-10) during the first 24 hours postoperatively.

Eventual side effects such as nausea/vomiting. Time necessary to perform the procedure. Pain during procedure execution quantified as Numerical Rating Scores (0-10) Hypnotic and opioids intraoperative consumption to ensure general anesthesia with Bispectral Index between 40 and 60.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-23
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-09
• Primary Completion: 2017-01
• Status Verified: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

• age> 18 years
• ASA score I - II - III
• undergoing elective reconstruction breast surgery
• signed informed consent

Exclusion Criteria

• chronic therapy with opioids/ antidepressants
• urgent/emergent surgery
• postoperative transfer to the intensive care unit
• known allergy to any drug medication
• local skin infection
• epilepsy
• alcohol or drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVB	Paravertebral Thoracic block	51 patients receiving US guided homolateral paravertebral thoracic block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).
PECS	Pectorals nerve block	51 patients receiving US guided pectorals nerve block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).
PECS	Morphine	51 patients receiving US guided pectorals nerve block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).
PVB	Levobupivacaine 0.25%	51 patients receiving US guided homolateral paravertebral thoracic block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).
PECS	Levobupivacaine 0.25%	51 patients receiving US guided pectorals nerve block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).
PVB	Morphine	51 patients receiving US guided homolateral paravertebral thoracic block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).

Primary Outcome Measures

Name	Time	Method
PCA morphine consumption in the two groups within the first 24 postoperative hours	24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Numerical Rating Scores for pain at rest and during movement	24 hours postoperatively
Postoperative nausea/vomiting incidence	24 hours postoperatively
Time of performance	During procedure execution
Propofol consumption in intraoperative period	Intraoperative period	Propofol consumption in intraoperative period to maintain total intravenous general anesthesia (BIS target 40-60). Propofol consumption in mg/kg/h
Opioids (remifentanyl) consumption in intraoperative period	Intraoperative period	Opioids (remifentanyl) consumption in intraoperative period to maintain total intravenous general anesthesia (systolic blood pression target: reduction of 20% from base line value). Remifentanyl in mcg/kg/h
Numerical Rating Scores during procedure execution	During procedure execution

Trial Locations

Locations (1)

Azienda Ospedaliera Istituti Ospitalieri di Cremona; 🇮🇹 Cremona, CR, Italy