Comparison of ESP Block Versus Serratus Block

Postoperative Pain Clinical Trial

Official title:

Comparison of the Ultrasound Guided Erector Spinae Plane Block Versus Serratus Plane Block in Totally Mastectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03619447
• Other study ID #: ESP vs Serratus
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 15, 2018
• Est. completion date: April 15, 2019

Study information

• Verified date: August 2018
• Source: Cukurova University
• Contact: Ebru Biricik
• Phone: 05052420223
• Email: ebrubiricik01[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Total 60 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent totally mastectomy will recruit to the study. The patients randomly divided into two groups. Ultrasound guided Erector spinae plane block (ESP) will perform with 15 ml bupivacaine+ 5 ml lidocaine in Group ESP and ultrasound guided serratus anterior plane (SAP) block will perform with 5 ml bupivacaine+ 5 ml lidocaine in Group SAP. Postoperative pain assessment will apply with 11-point numerical rating scale (NRS) and postoperative analgesic requirement will calculate and record with morphine consumption (patient controlled analgesia).

Description:

In this study, total 60 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent totally mastectomy will recruit. Using with computer randomisation, the patients allocate into two groups. Anaesthesia induction will perform with 2 mg/kg propofol, 0.6 mg/kg rocuronium and 2 microgram/kg fentanil and general anaesthesia will maintain with sevoflurane %1-2 +%40-60 O2-N20 mixture and remifentanil infusion. All of the blocks will perform under general anaesthesia. Ultrasound guided Erector spinae plane block (ESP) will perform with 15 ml bupivacaine+ 5 ml lidocaine in Group ESP and ultrasound guided serratus anterior plane (SAP) block will perform with 5 ml bupivacaine+ 5 ml lidocaine in Group SAP. Postoperative pain, analgesic requirement and complications will evaluate. Postoperative pain assessment will apply with 11-point numerical rating scale (NRS) and postoperative analgesic requirement will calculate and record with morphine consumption (patient controlled analgesia).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA I-II patients

• Being volunteer

• Total mastectomy

Exclusion Criteria:

• ASA III and over

• Renal and hepatic failure

• Non Volunteers

• Emergency procedures

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• ESP block group
USG guided Erector spinae block (ESP) will perform bilaterally.
• serratus block group
USG guided serratus plane block will perform bilaterally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphine consumption	Patient controlled analgesia (PCA) will provide with morphine PCA. Total morphine consumption will calculate and record till the postoperative 24th hours.	up to postoperative 24th hours.
Secondary	numerical rating scale score	Postoperative pain assessment will apply with 11-point numerical rating scale. These scores will record till the postoperative 24 th hours.	up to postoperative 24th hours.