Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery

Not Applicable

Withdrawn

• Conditions: Breast Cancer; Anesthesia, Local
• Interventions: Procedure: ESP BLOCK; Procedure: PECS BLOCK

• Registration Number: NCT03811262
• Lead Sponsor: University of Padova

Brief Summary

Backgroung:Regional anesthesia in breast surgery is of paramount importance to reduce pain in perioperative period.

PECS II block is an interfascial block that has been used widely as regional anesthesia technique in breast surgery.

ESP block is a novel interfascial block proposed in 2016 by Forero. Several reports used this technique in breast surgery to provide analgesia but to date no studies comparing these technique exists.

Our hypotesis is that this two technique are equally able to provide analgesia in breast surgery.

Study type: RCT, single blind.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-22
• Study Start: 2022-01-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-23
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Mastectomy program with axillary clearence

Exclusion Criteria

• bilateral surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP BLOCK	ESP BLOCK	Intervention:30 ml of 0.25% Levobupivacaine where: ESP block as described by Forero at T5 level (single injection between transversour process and erector spinae muscles)
PECS block	PECS BLOCK	Intervention:30 ml of 0.25% Levobupivacaine where:PECS II block as described by Blanco.

Primary Outcome Measures

Name	Time	Method
Intraoperative Fentanyl consumption	Intraoperative	Intraoperative fentanyl dose (mcg) difference between ESP group and PECS group.

Secondary Outcome Measures

Name	Time	Method
Nausea and vomit incidence	postoperative period (24h)	Incidence of nausea and vomiting in postoperative period
Time to first opioid consumption in the postoperative period	postoperative period (24h)	Time (minutes) to first opioid consumption in the postoperative period
NRS at 12 hour	twelth postoperative hour	NRS (0-10) difference at twelth postoperative hour between ESP group and PECS group
NRS at 24 hour	twentyfourth postoperative hour	NRS (0-10) difference at twentyfourth postoperative hour between ESP group and PECS group
NRS at 6 hour	sixth postoperative hour	NRS (0-10) difference at sixth postoperative hour between ESP group and PECS group
Patient satisfaction at 24 hour	postoperative period (24h)	Patient satisfaction (0-10) difference regarding anesthesia management at twentyfourth postoperative hour between ESP group and PECS group
Postoperative morphine consumption	postoperative period (24h)	postoperative morphine dose (mg) difference between ESP group and PECS group.
Other complication incidence	postoperative period (24h)	Incidence of other complcations linked to anesthesia in postoperative period
Intraoperative Fentanyl consumption(mcg/kg/h)	Intraoperative	Intraoperative fentanyl dose (mcg/kg/h) difference between ESP group and PECS group.

Trial Locations

Locations (1)

University of Padova; 🇮🇹 Padova, Veneto, Italy