Dual Injection ESPB Versus Single Injection ESPB for Lapa... | NCT05633329

Studies
Dual Injection ESPB Versus Single Injection ESPB for Laparotomies

NCT05633329

Sponsor

Minia University

Status

Completed

Last Update Posted

Jun 22, 2023Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Post Operative Pain
Regional Block

Interventions

single level
dual level

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

Jun 2023

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

Dec 7, 2022Actual

Primary Completion Date

May 1, 2023Actual

Completion Date

Jun 1, 2023Actual

First Submitted Date

Nov 4, 2022

First Submission Date that Met QC Criteria

Nov 21, 2022

First Posted Date

Dec 1, 2022Actual

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

Jun 17, 2023

Last Update Posted Date

Jun 22, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hassan Mokhtar Elshorbagy Hetta, lecturer of anesthesia and ICU, Minia UniversityPrincipal Investigator

Lead Sponsor

Minia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To evaluate and compare the efficacy of single level injection erector spinae plane block versus double level injection Erector spinae plane block in laparotomies

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

Not Applicable

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
single ESPB	Experimental	single injection at level T8	Procedure: single level
dual ESB	Experimental	dual injection at level T7 and T9	Procedure: dual level

Interventions

Name	Type	Description	Arm Group Labels	Other Names
single level	Procedure	injection of 40 ml bupivacaine 0.25 at T8 (20 ml on each side)	single ESPB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
first analgesic request	time to request fentanyl	24 hours

Secondary Outcomes

Measure	Description	Time Frame
resting visual analogue pain scale	pain score at rest from 0-10 which 0 mean no pain and 10 the worst pain	24 hours
dynamic visual analogue pain scale	pain score at movement (cough) from 0-10 which 0 mean no pain and 10 the worst pain

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age18-60.
Both genders.
abdominal surgery.
ASA I-III.

Exclusion Criteria:

Drug allergy.
Morbid obesity (BMI >40 kg/m2).
Psychiatric disorder.
Opiod dependence.
patient refuse.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
hassan m. hetta, lecturer	Minia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Minia University		Minya	Minya Governorate	61511	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

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D010146	Pain

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005430	Floors and Floorcoverings

Ancestor Terms

ID	Term
D005160	Facility Design and Construction
D001108	Architecture
D013676	Technology, Industry, and Agriculture

Browse Leaves

Not provided

Browse Branches

Not provided