Laparoscopic Guided Transversus Abdominis Plane Block Ver... | NCT02973451

Studies
Laparoscopic Guided Transversus Abdominis Plane Block Versus Trocar Site Infiltration in Gynecologic Laparoscopy.

NCT02973451

Sponsor

Zagazig University

Status

Completed

Last Update Posted

Sep 5, 2018Actual

Enrollment

80Estimated

Phase

Phase 2

Conditions

Post Operative Local Anaesthesia

Interventions

Laparoscopic Guided Bupivacaine
local Bupivacaine

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

Nov 2016

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

Apr 2016

Primary Completion Date

Jul 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Nov 22, 2016

First Submission Date that Met QC Criteria

Nov 23, 2016

First Posted Date

Nov 25, 2016Estimated

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

Sep 3, 2018

Last Update Posted Date

Sep 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 compare between Laparoscopic Guided Transversus Abdominis Plane Block and Trocar Site Infiltration as postoperative analgesia in Gynecologic Laparoscopic surgery.

Detailed Description

two groups of patients who are eligible for Gynecologic Laparoscopy were randomized to either Laparoscopic Guided Transversus Abdominis Plane Block or Trocar Site Infiltration at the end of the operation.

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 2

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
Laparoscopic	Active Comparator	Laparoscopic Guided Transversus Abdominis Plane Block using Bupivacaine	Drug: Laparoscopic Guided Bupivacaine
local	Active Comparator	Trocar Site Infiltration of Bupivacaine	Drug: local Bupivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic Guided Bupivacaine	Drug	Bupivacaine Laparoscopic GuidedTransversus Abdominis Plane Block	Laparoscopic

Measure	Description	Time Frame
Pain Scores		24 Hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients Need Gynecologic Laparoscopy

Exclusion Criteria:

diagnosed with chronic pain syndrome
have a postoperative intraperitoneal drain
necessitating alteration to laparotomy.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ibrahim A el sharkwy, MD	Zagazig University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zagazig University		Zagazig			Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided