Comparison of ESP Block Versus Serratus Block

• ClinicalTrials.gov Identifier: NCT03619447
• Recruitment Status: Unknown
• First Posted: August 7, 2018
• Last Update Posted: August 7, 2018
• Sponsor: Cukurova University
• Information provided by (Responsible Party): ebru biricik, Cukurova University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Drug: ESP block group; Drug: serratus block group	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: Both participants and anaesthesia provider will not know which intervention applied. Another anaesthesia provider who did not perform any block will follow and record to the study data.
• Primary Purpose: Treatment
• Official Title: Comparison of the Ultrasound Guided Erector Spinae Plane Block Versus Serratus Plane Block in Totally Mastectomy
• Estimated Study Start Date: September 15, 2018
• Estimated Primary Completion Date: March 15, 2019
• Estimated Study Completion Date: April 15, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Drug: ESP block group; USG guided Erector spinae block (ESP) will perform bilaterally.; Other Name: USG guided ESP block group
Active Comparator: 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.	Drug: serratus block group; USG guided serratus plane block will perform bilaterally; Other Name: USG guided serratus plane block

Outcome Measures

Primary Outcome Measures :

1. morphine consumption [ Time Frame: 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 :

1. numerical rating scale score [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Ebru Biricik; 05052420223; ebrubiricik01@gmail.com

Contact: Feride Karacaer; 05062628416; feridekaracaer@gmail.com

Sponsors and Collaborators

Cukurova University

Investigators

• Principal Investigator: Ebru Biricik; Cukurova University

More Information

• Responsible Party: ebru biricik, Anesthesiologist, Cukurova University
• ClinicalTrials.gov Identifier: NCT03619447
• Other Study ID Numbers: ESP vs Serratus
• First Posted: August 7, 2018
• Last Update Posted: August 7, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations