Clinical trial NCT03811262: Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery
Official title: Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Anesthesia, Local
Keywords: PECS
ESP
RCT
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-centre, prospective; double blinded randomised interventional clinical trial.

Patients will be randomly allocated to group "PECS" or "ESP" using a closed envelope technique.

Group "PECS" will receive PECS II block as described by Blanco using 30 ml Levobupivacaine 0.25% Group "ESP" will receive ESP block as described by forero using 30 ml Levobupivacaine 0.25% at T5 level.

Blocks will be executed after general anesthesia induction. All partecipants will receive Fentanyl 2 mcg/kg and Propofol 2 mg/kg for induction. Anesthesia will be mantained with Propofol to obtain a BIS level between 40-50. Patients will receive Fentanyl 33 mcg whenever blood pressure and/or hear rate raise more than 20% from baseline after surgical stimulation. At the end of the surgery patients will receive acetominophen 1 g. postoperative therapy: acetominophen 1g/8hr and ketoprofen 100 mg/12hr.

Patients will receive 2 mg Morphine whenever a NRS \> 3.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Mastectomy program with axillary clearence

Exclusion Criteria:

* bilateral surgery

Primary outcomes:
measure: Intraoperative Fentanyl consumption
timeFrame: Intraoperative
Secondary outcomes:
measure: NRS at 6 hour
timeFrame: sixth postoperative hour
measure: NRS at 12 hour
timeFrame: twelth postoperative hour
measure: NRS at 24 hour
timeFrame: twentyfourth postoperative hour
measure: Patient satisfaction at 24 hour
timeFrame: postoperative period (24h)
measure: Time to first opioid consumption in the postoperative period
timeFrame: postoperative period (24h)
measure: Postoperative morphine consumption
timeFrame: postoperative period (24h)
measure: Nausea and vomit incidence
timeFrame: postoperative period (24h)
measure: Other complication incidence
timeFrame: postoperative period (24h)
measure: Intraoperative Fentanyl consumption(mcg/kg/h)
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University of Padova
state: Veneto
Study officials:
affiliation: Department of Medicine, DIMED - Section of Anesthesiology and Intensive Care. University of Padova
name: Alessandro De Cassai, MD
role: PRINCIPAL_INVESTIGATOR
References: