Comparison of ESP Block Versus Serratus Block

Phase 4

• Conditions: Postoperative Pain
• Interventions: Drug: ESP block group; Drug: serratus block group

• Registration Number: NCT03619447
• Lead Sponsor: Cukurova University

Brief 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).

Detailed 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).

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-06
• Last Update Submitted: 2018-08-06
• Study First Posted: 2018-08-07
• Last Update Posted: 2018-08-07
• Study Start: 2018-09-15
• Primary Completion: 2019-03-15
• Study Completion: 2019-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA I-II patients
• Being volunteer
• Total mastectomy

Exclusion Criteria

• ASA III and over
• Renal and hepatic failure
• Non Volunteers
• Emergency procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP block group	ESP block group	Under general anaesthesia, Ultrasound guided ESP block will perform at the T6 level with15 ml bupivacain+ 5ml lidocaine, bilaterally. Morphine 0.1 mg/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with morphine will apply to the all patients. Postoperative pain assessment and morphine consumption will record till the postoperative 24 th hours.
serratus block group	serratus block group	Under general anaesthesia, Ultrasound guided SAP block will perform at the T6 level with15 ml bupivacain+ 5ml lidocaine, bilaterally. Morphine 0.1 mg/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with morphine will apply to the all patients. Postoperative pain assessment and morphine consumption will record till the postoperative 24 th hours.

Primary Outcome Measures

Name	Time	Method
morphine consumption	up to postoperative 24th hours.	Patient controlled analgesia (PCA) will provide with morphine PCA. Total morphine consumption will calculate and record till the postoperative 24th hours.

Secondary Outcome Measures

Name	Time	Method
numerical rating scale score	up to postoperative 24th hours.	Postoperative pain assessment will apply with 11-point numerical rating scale. These scores will record till the postoperative 24 th hours.