Comparison of ESP Block Versus Serratus Block

NCT03619447 | Unknown Phase 4

• 1 other identifier: ESP vs Serratus
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• numerical rating scale score

  up to postoperative 24th hours.

Study Arms (2)

ESP block group

ACTIVE COMPARATOR

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

serratus block group

ACTIVE COMPARATOR

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

Interventions

ESP block group DRUG

USG guided Erector spinae block (ESP) will perform bilaterally.

Also known as: USG guided ESP block group

ESP block group

serratus block group DRUG

USG guided serratus plane block will perform bilaterally

Also known as: USG guided serratus plane block

serratus block group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cukurova University: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ebru Biricik

  Cukurova University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ebru Biricik

CONTACT

05052420223; ebrubiricik01@gmail.com

Feride Karacaer

CONTACT

05062628416; feridekaracaer@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 7, 2018
• Study Start: September 15, 2018
• Primary Completion: March 15, 2019
• Study Completion: April 15, 2019
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share