Comparaison of ESP Block and TAP Block | NCT04176770

Studies
Comparaison of ESP Block and TAP Block

NCT04176770

Sponsor

Mongi Slim Hospital

Status

Unknown status

Last Update Posted

Nov 29, 2019Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Post Operative Pain

Interventions

ESP Block
TAP Block

Countries

Tunisia

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

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2019Estimated

Primary Completion Date

May 30, 2020Estimated

Completion Date

Jun 30, 2020Estimated

First Submitted Date

Nov 22, 2019

First Submission Date that Met QC Criteria

Nov 22, 2019

First Posted Date

Nov 25, 2019Actual

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

Nov 26, 2019

Last Update Posted Date

Nov 29, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mhamed Sami Mebazaa, professor, head of the anesthesia and ICU departement, Mongi Slim HospitalPrincipal Investigator

Lead Sponsor

Mongi Slim HospitalOTHER

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

This study aim to compare the efficiency and the analgesic effect of Erector Spinal Plane Block versus TAP Block after laparoscopic cholecystectomy.

Detailed Description

This study will include patients scheduled for laparoscopic cholecystectomy, ASA status 1 or 2. patients will be randomized in 2 groups to recieve post operative analgesia with -ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.

-TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%

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

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESP group	Experimental	ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.	Procedure: ESP Block
TAP Block	Experimental	TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%	Procedure: TAP Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ESP Block	Procedure	ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.	ESP group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post Operative analgesia	Post operative analgesia assessed with Numerical rating scale (0=minimum, 10= Maximum)	24 hours after intervention

Secondary Outcomes

Measure	Description	Time Frame
post operative analgesic consumption	Amount of Morphin needed for analgesia	24 hours after intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients
ASA status I or II
scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

laparotomy
unplanned ICU admission

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mhamed Sami Mebazaa, professor	Contact	0021622252589		msmebazaa@gmail.com
Asma Ben Souissi, Ass Prof	Contact	0021698336883		bsouissiasma@gmail.com

Overall Officials

Name	Affiliation	Role
Mhamed Sami Mebazaa, Professor	Mongi Slim Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mongi Slim Hospital		Tunis		2046	Tunisia

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
D000377	Agnosia

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

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Browse Branches

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