Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block in Pediatric Patient

NCT ID: NCT03294291

Last Updated: 2018-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-11-15

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;Caudal block 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 1-9 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 caudal block at the begin of surgery.

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 and Modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score will be used.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Quadratus Lumborum block group

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. Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. Under ultrasound 0.7 ml/kg bupivacaine 0.25 % injected unilaterally at the posterior border of the quadratus lumborum muscle.

Group Type: ACTIVE_COMPARATOR

Quadratus lumborum block

Intervention Type: PROCEDURE

Postoperative pain procedure

Caudal 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 caudal block wil performe with bupivacaine 0.7 ml/kg as 0.25%.

Group Type: ACTIVE_COMPARATOR

Caudal block

Intervention Type: PROCEDURE

Postoperative pain procedure

Interventions

Quadratus lumborum block

Postoperative pain procedure

Intervention Type: PROCEDURE

Caudal block

Postoperative pain procedure

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age 1-9

2. ASA physical status I-II

3. Undergoing unilateral low abdominal surgery

Exclusion Criteria

1. History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult

2. Parent refusal

3. History of allergic reactions to local anesthetics

4. Rash or infection at the injection site

5. Anatomical abnormality

6. Bleeding diatheses

7. Coagulopathy,

8. History of diseases

1. renal

2. hepatic

3. cardiac

4. upper or lower airway

5. neurological

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role: lead

Responsible Party

Gözen Öksüz

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gözen Öksüz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kahramanmaras Sutcu Imam University

Locations

KahramanmarasSIU

Kahramanmaraş, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 28759502 (View on PubMed)

Oksuz G, Arslan M, Urfalioglu A, Guler AG, Teksen S, Bilal B, Oksuz H. Comparison of quadratus lumborum block and caudal block for postoperative analgesia in pediatric patients undergoing inguinal hernia repair and orchiopexy surgeries: a randomized controlled trial. Reg Anesth Pain Med. 2020 Mar;45(3):187-191. doi: 10.1136/rapm-2019-101027. Epub 2020 Jan 5.

Reference Type: DERIVED

PMID: 31907294 (View on PubMed)

Other Identifiers

2017/10-08

Identifier Type: -

Identifier Source: org_study_id