TAP Block Alone Versus TAPblock With Rectus Sheath Block... | NCT02854553

Studies
TAP Block Alone Versus TAPblock With Rectus Sheath Block in Liposuction Surgery

NCT02854553

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Aug 3, 2016Estimated

Enrollment

48Estimated

Phase

Not Applicable

Conditions

Pain

Interventions

Transversus abdominis plane block
rectus sheath block

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

Jul 2016

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

Sep 2016

Primary Completion Date

Sep 2017Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

Jul 30, 2016

First Submission Date that Met QC Criteria

Aug 2, 2016

First Posted Date

Aug 3, 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

Aug 2, 2016

Last Update Posted Date

Aug 3, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hassan Mohamed Ali, lecturer in anesthesia department Cairo university, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The transversus abdominis plane (TAP) block is an effective regional nerve block for the anterior abdominal wall. An anesthesiologist typically administers the TAP block preoperatively with ultrasound guidance. It is not yet commonly used during anterior abdominal wall liposuction, where postprocedural pain remains a major concern for patients and surgeons.

Detailed Description

The author investigated the feasibility of administering the TAP block under direct vision and compared postoperative narcotic use in patients who received analgesia by TAP block vs with TAP block i addition to rectus sheath block, both performed under direct vision during anterior abdominal wall liposuction.

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

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TAP	Experimental	Transversus abdominis plane block	Procedure: Transversus abdominis plane block
TAP and rectus sheath block	Experimental	Transversus abdominis plane block with rectus sheath block	Procedure: Transversus abdominis plane block Procedure: rectus sheath block
control	No Intervention	no truncal blocks, conventional analgesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transversus abdominis plane block	Procedure	ultra sound guides Transversus abdominis plane block	TAP TAP and rectus sheath block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain	visual analogue scale for pain assessment	Three days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I-II, consent,

Exclusion Criteria:

allergy, coagulopathy, refusal, mentally unstable

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hassan Ali, lecturer	Contact	1001733687		hassan364@hotmail.com
Hassan Ali	Contact	1001733687		hassan364@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University		Cairo	Giza Governorate	1234	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided