Clinical trial NCT02715999: Transversus Abdominis Plane Versus Quadratus Lumborum Block for Pediatrics
Official title: Transversus Abdominis Plane Versus Quadratus Lumborum Block for Pediatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: time to first use of analgesic
timeFrame: 24 hour
Secondary outcomes:
measure: Total paracetamol consumption
timeFrame: 24 hour
measure: Parent satisfaction scores
timeFrame: 24 hour
measure: FLACC (face, legs, activity, cry, consolability)
timeFrame: 1,2,4,6,12,24 hour
Other outcomes:
Locations:
city: Kahramanmaras
country: Turkey
facility: Kahramanmaras Sutcu Imam University Hospital
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Gözen Öksüz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.