Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Children

Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial

Postoperative pain management in children is still standing as a problem to solve. Effect of quadratus lumborum block has been shown to be a promising technique to overcome postoperative pain in children undergoing low abdominal surgeries. Erector spinae plane block is a new defined relatively safer and easier regional anesthesia technique which could be used for this purpose. Primary aim of this double blinded randomized controlled trial is to compare the analgesic efficacy of this two block techniques in this group of pediatric patients.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Erector Spinae Plane Block; Drug: Bupivacaine (Block Drug); Procedure: Quadratus Lumborum Block

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli
    • İzmit, Kocaeli, Turkey, 41340
      • Kocaeli University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1-7 years of age
• ASA I-II
• Undergoing elective low abdominal surgery

Exclusion Criteria:

• infection of the skin at the site of needle puncture area
• patients with known allergies to any of the study drugs
• coagulopathy
• ASA III-IV
• Patients with neurological disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESP Group; Erector Spinae Plane Block Group Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks	Procedure: Erector Spinae Plane Block; Erector Spinae Plane block will be administered under general anesthesia before the surgery; Drug: Bupivacaine (Block Drug); 0,25% Bupivacaine was used 0,5ml/kg (max. 20cc) for block performances
Active Comparator: QLB Group; Quadratus Lumborum Block Group Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks	Drug: Bupivacaine (Block Drug); 0,25% Bupivacaine was used 0,5ml/kg (max. 20cc) for block performances; Procedure: Quadratus Lumborum Block; Quadratus Lumborum Block will be administered under general anesthesia before the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	Postoperative first 6hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for analgesic	Number of patients who required analgesic in the first 24 hour	24 hour
Time to first analgesic drug	Time to first analgesic drug will be recorded	first 48 hour

Collaborators and Investigators

• Sponsor: Kocaeli University

Publications and helpful links

General Publications

• Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Postoperative Pain; quadratus lumborum block; Erector spinae plane block; Pediatric Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2018-95

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No