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

Breast Cancer Clinical Trial

Official title:

Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery:a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03811262
• Other study ID #: ESPvsPECS/AOP
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 2023

Study information

• Verified date: May 2022
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Mastectomy program with axillary clearence

Exclusion Criteria:

• bilateral surgery

Related Conditions & MeSH terms

• Anesthesia, Local
• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• ESP BLOCK
local anesthetic will be injected between transverous process and erector spinae muscle
• PECS BLOCK
local anesthetic will be injected between pectoralis minor and pectoralis major (10 ml) and between pectoralis minor and serratus (20 ml)

Locations

Country	Name	City	State
Italy	University of Padova	Padova	Veneto

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

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