NCT04720287

Brief Summary

The aim of this study is to compare the postoperative pain control in children undergoing lower abdominal surgeries receiving QL block with those receiving caudal bupivacaine/ neostigmine.

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 phase_4

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

January 19, 2021

Last Update Submit

May 26, 2021

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

  • The total amount of paracetamol doses (mg)

    The total amount of paracetamol doses (mg)

    24 hours postoperatively

Study Arms (2)

Group 1(QL group)

ACTIVE COMPARATOR
Drug: bupivacaine/ neostigmine.

Group 2 (CB group)

ACTIVE COMPARATOR
Drug: bupivacaine/ neostigmine.

Interventions

bupivacaine/ neostigmine.DRUG

will receive bilateral ultrasound guided QLB

Group 1(QL group)

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients American Society of Anesthesiologists physical status (ASA) I or II.
  • Consent from parents or legal guardian(s).
  • Lower abdominal surgeries.

You may not qualify if:

  • Parents' refusal or legal guardian's refusal.
  • Infection at the injection site.
  • Known allergy to bupivacaine and/or neostigmine.
  • Contraindications to regional anesthesia (including coagulopathy and local infection).
  • Anatomical anomalies at the site of the block.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

BupivacaineNeostigmine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylammonium CompoundsQuaternary Ammonium CompoundsOnium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 22, 2021

Study Start

February 1, 2021

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

May 27, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)