NCT03811392

Brief Summary

To compare between caudal block and ultrasound guided Quadratus Lamborum block in reducing postoperative pain, opioid consumption, and recovery time following elective inguinal herniorraphy. The primary outcome:

  • to compare between caudal block and ultrasound guided quadratus lamborum block. The secondary outcome:
  • duration of postoperative analgesia.
  • incidence of postoperative complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

January 17, 2019

Last Update Submit

December 30, 2019

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain.

    FLACC Scale from 0 to 10

    24 hours

Study Arms (2)

Hernioraphy/Caudal block

ACTIVE COMPARATOR

patients will receive a caudal block after induction of general anaesthesia.

Procedure: Hernioraphy/Caudal block

Hernioraphy/Quadratus Lumborum block

ACTIVE COMPARATOR

patients will receive ultrasound guided quadrates lumborum block (QL )

Procedure: Hernioraphy/Quadratus Lumborum block

Interventions

Hernioraphy/Caudal blockPROCEDURE

30 patients will receive a caudal block after induction of general anaesthesia

Hernioraphy/Caudal block
Hernioraphy/Quadratus Lumborum blockPROCEDURE

30 patients will receive ultrasound guided quadrates lumborum block

Hernioraphy/Quadratus Lumborum block

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • Infection at the site of needle insertion Neuromuscular disease/damage Anticoagulation or bleeding disorder. Sepsis Allergy to local anaesthetics. Guardians refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, 21111, Egypt

Location

Related Publications (16)

  • Meier DE, OlaOlorun DA, Omodele RA, Nkor SK, Tarpley JL. Incidence of umbilical hernia in African children: redefinition of "normal" and reevaluation of indications for repair. World J Surg. 2001 May;25(5):645-8. doi: 10.1007/s002680020072.

    PMID: 11369993BACKGROUND

  • Finley AG, McGrath PJ, Forward PS, McNeill G, Fitzgerald P. Parents' management of children's pain following 'minor' surgery. Pain. 1996 Jan;64(1):83-87. doi: 10.1016/0304-3959(95)00091-7.

    PMID: 8867249BACKGROUND

  • Johr M. Practical pediatric regional anesthesia. Curr Opin Anaesthesiol. 2013 Jun;26(3):327-32. doi: 10.1097/ACO.0b013e3283606a1e.

    PMID: 23614955BACKGROUND

  • Hadzic A, Karaca PE, Hobeika P, Unis G, Dermksian J, Yufa M, Claudio R, Vloka JD, Santos AC, Thys DM. Peripheral nerve blocks result in superior recovery profile compared with general anesthesia in outpatient knee arthroscopy. Anesth Analg. 2005 Apr;100(4):976-981. doi: 10.1213/01.ANE.0000150944.95158.B9.

    PMID: 15781509BACKGROUND

  • Ecoffey C. Local anesthetics in pediatric anesthesia: an update. Minerva Anestesiol. 2005 Jun;71(6):357-60.

    PMID: 15886601BACKGROUND

  • Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anat. 2012 Dec;221(6):507-36. doi: 10.1111/j.1469-7580.2012.01511.x. Epub 2012 May 27.

    PMID: 22630613BACKGROUND

  • Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.

    PMID: 24249997BACKGROUND

  • Waldman SD. Caudal epidural nerve block: prone position. In: Atlas of Interventional Pain Management, 2nd edn. Philadelphia: Saunders, 2004 ; 380-92

    BACKGROUND

  • Machotta A, Risse A, Bercker S, Streich R, Pappert D. Comparison between instillation of bupivacaine versus caudal analgesia for postoperative analgesia following inguinal herniotomy in children. Paediatr Anaesth. 2003 Jun;13(5):397-402. doi: 10.1046/j.1460-9592.2003.01080.x.

    PMID: 12791112BACKGROUND

  • 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.

    PMID: 28759502BACKGROUND

  • Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

    PMID: 9220806BACKGROUND

  • Nafiu OO, Voepel-Lewis T, Morris M, Chimbira WT, Malviya S, Reynolds PI, Tremper KK. How do pediatric anesthesiologists define intraoperative hypotension? Paediatr Anaesth. 2009 Nov;19(11):1048-53. doi: 10.1111/j.1460-9592.2009.03140.x. Epub 2009 Oct 1.

    PMID: 19796350BACKGROUND

  • Pawar D. Common post-operative complications in children. Indian J Anaesth. 2012 Sep;56(5):496-501. doi: 10.4103/0019-5049.103970.

    PMID: 23293390BACKGROUND

  • Chiu SN, Lin LY, Wang JK, Lu CW, Chang CW, Lin MT, Hua YC, Lue HC, Wu MH. Long-term outcomes of pediatric sinus bradycardia. J Pediatr. 2013 Sep;163(3):885-9.e1. doi: 10.1016/j.jpeds.2013.03.054. Epub 2013 Apr 25.

    PMID: 23623512BACKGROUND

  • Hohne C. Postoperative nausea and vomiting in pediatric anesthesia. Curr Opin Anaesthesiol. 2014 Jun;27(3):303-8. doi: 10.1097/ACO.0000000000000073.

    PMID: 24722005BACKGROUND

  • Liversidge XL, Taylor DM, Liu B, Ling SL, Taylor SE. Variables associated with parent satisfaction with their child's pain management. Emerg Med Australas. 2016 Feb;28(1):39-43. doi: 10.1111/1742-6723.12519. Epub 2015 Dec 20.

    PMID: 26685807BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Mohammad Hazem I Ahmad Sabry, MB,ChB MD

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia/Head of Ambulatory surgery and pain clinic.

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 22, 2019

Study Start

October 1, 2019

Primary Completion

December 10, 2019

Study Completion

December 11, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)