Transversus Abdominis Plane Versus Quadratus Lumborum Block for Pediatrics

Postoperative Pain Clinical Trial

Official title:

Transversus Abdominis Plane Versus Quadratus Lumborum Block for Pediatrics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715999
• Other study ID #: 05-02/2016
• Status: Completed
• Phase: N/A
• First received: March 13, 2016
• Last updated: November 28, 2017
• Start date: February 2016
• Est. completion date: January 2017

Study information

• Verified date: November 2017
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to find the best way to decrease pain in children whom have had low abdominal surgery. Investigators will perform two technique of trunk block; Transversus abdominis plane or Quadratus lumborum block .The method used is often chosen by which one the doctor has more experience using. The Investigator plans to find out if one of the methods is more effective and/or safer than the other method.

The results of this study will help learn how to best control pain in children having surgery low abdominal surgery.

Description:

Children aged 1-7 years undergoing lower abdominal surgeries would be recruited in this randomized study.

Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood pressure.

After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed, lash reflex disappeared, no coughing, gagging, swallowing).After ethical committee approval, informed written consent will be obtained from all patients.

Consenting patients scheduled to have unilaterally low abdominal surgery(inguinal hernia,hydrocele,undescended testicles surgery will be randomised to unilateral Quadratus lumborum block or Transversus abdominis plane block at the begin of surgery.

All patients will be in the lateral position . Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. The spread of injectate will be seed on ultrasound.The dose of local anaesthetic in both groups will be 0.5 ml/kg 0.2 % Bupivacaine. Anesthesia would be maintained with 2% sevoflurane An increase in blood pressure or heart rate by more than 15% from preoperative value was defined as insufficient analgesia and was treated with fentanyl 0.5 µ/kg. Saline dextrose 5% (1:1) solution was infused in a dose of 12 ml/ kg /h.

All patients heart rate,MAP and Oxygen saturation record intraoperatively. All patients will receive paracetamol if requirement for postoperative analgesia.All patient will transfer from PACU to day-surgery unit (DSU) if they achieved Modified Aldrete Score of ten.

All patients will be assessed postoperatively by a blinded investigator: in the postanesthesia care unit and at 30 min 1,2, 4, 6, 12, 24, hour postoperatively.FLACC score will be used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

Inclusion Criteria:

• ASA physical status I-II

• undergoing unilateral low abdominal surgery

Exclusion Criteria:

• history of allergic reactions to local anesthetics

• rash or infection at the injection site

• anatomical abnormality

• bleeding diatheses, coagulopathy, liver diseases

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Quadratus Lumborum Block
After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory.All patients will be in the lateral position . Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. Under ultrasound 0.5 ml/kg bupivacaine 0.2 % injected unilaterally at the posterior border of the quadratus lumborum muscle
• Transversus Abdominis Plane Block
After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory. All patients will be in the lateral position . Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. Under ultrasound 0.5 ml/kg bupivacaine 0.2 % injected unilaterally between internal oblique and transversus abdominis muscles.

Locations

Country	Name	City	State
Turkey	Kahramanmaras Sutcu Imam University Hospital	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to first use of analgesic	By investigators until hospital discharge, then through telephone interview with parents after that	24 hour
Secondary	Total paracetamol consumption	By investigators until hospital discharge, then through telephone interview with parents after that	24 hour
Secondary	Parent satisfaction scores	By investigators until hospital discharge, then through telephone interview with parents after that	24 hour
Secondary	FLACC (face, legs, activity, cry, consolability)	By investigators until hospital discharge, then through telephone interview with parents after that	1,2,4,6,12,24 hour