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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463382
• Other study ID #: 2018-95
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: November 2018
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Erector Spinae Plane Block
Erector Spinae Plane block will be administered under general anesthesia before the surgery
• Quadratus Lumborum Block
Quadratus Lumborum 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

Locations

Country	Name	City	State
Turkey	Kocaeli University Hospital	Izmit	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to first analgesic drug	Time to first analgesic drug will be recorded	first 48 hour
Secondary	Need for analgesic	Number of patients who required analgesic in the first 24 hour	24 hour