Ultrasound Guided Quadratus Lumborum Block Compared to Ca... | NCT04720287

Studies
Ultrasound Guided Quadratus Lumborum Block Compared to Caudal Bupivacaine/ Neostigmine in Pediatric Lower Abdominal Surgeries

NCT04720287

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

May 27, 2021Actual

Enrollment

60Actual

Phase

Phase 4

Conditions

Postoperative Analgesia

Interventions

bupivacaine/ neostigmine.
bupivacaine/ neostigmine.

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

Apr 30, 2021Actual

Completion Date

Apr 30, 2021Actual

First Submitted Date

Jan 19, 2021

First Submission Date that Met QC Criteria

Jan 19, 2021

First Posted Date

Jan 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2021

Last Update Posted Date

May 27, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr.Ibrahim Mamdouh Esmat, Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt., Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1(QL group)	Active Comparator		Drug: bupivacaine/ neostigmine.
Group 2 (CB group)	Active Comparator		Drug: bupivacaine/ neostigmine.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bupivacaine/ neostigmine.	Drug	will receive bilateral ultrasound guided QLB	Group 1(QL group)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The total amount of paracetamol doses (mg)	The total amount of paracetamol doses (mg)	24 hours postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain-Shams University Hospitals		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
D009388	Neostigmine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided