NCT05493085

Brief Summary

Compare between the analgesic effect of the Ultrasound-guided quadratus lumborum block and single Caudal epidural injection in pediatric patients undergoing surgeries with supraumbilical incisions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

June 1, 2022

Last Update Submit

January 19, 2023

Conditions

Post Operative Pain, Acute

Outcome Measures

Primary Outcomes (1)

  • Pain score

    Face, leg, activity, cry and consolability score With score of 0 meaning no pain and requires no intervention and score of 10 indicating the worst imaginable pain requiring rescue analgesia

    24 hours postoperative

Study Arms (2)

Quadratus Lumborum

ACTIVE COMPARATOR

Patients will receive Ultrasound-guided quadratus lumborum block

Procedure: Quadratus lumborum block

Caudal epidural

ACTIVE COMPARATOR

Patients will receive single Caudal epidural injection

Procedure: Caudal epidural injection

Interventions

Quadratus lumborum blockPROCEDURE

Ultrasound-guided quadratus lumborum block

Quadratus Lumborum
Caudal epidural injectionPROCEDURE

Single Caudal epidural injection

Caudal epidural

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Any pediatric patient aged from 2 to 8 years undergoing abdominal Surgery with Supraumbilical umbilical incision

You may not qualify if:

  • parents refusal to participate in the study,
  • previous history of allergy to local anesthetics
  • hemodynamic instability
  • Coagulopathy,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university hospital

Cairo, Abbasia, 11213, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sherif Wadei, MD

    AinShams University, Anesthesia department

    STUDY CHAIR

Central Study Contacts

Mohamed A Tolba, MD

CONTACT

0020 115 6622298Mohamedtolba@med.asu.edu.eg

Aya H Moussa, MD

CONTACT

0020 1114555939ayahisham@med.asu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2022

First Posted

August 9, 2022

Study Start

June 15, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)