Trial on TAP Block After Bariatric Surgery | NCT03411772

Studies
Trial on TAP Block After Bariatric Surgery

NCT03411772

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Dec 5, 2018Actual

Enrollment

92Actual

Phase

Not Applicable

Conditions

Morbid Obesity

Interventions

TAP block
Bariatric surgery

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

Dec 2018

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

Jan 10, 2018Actual

Primary Completion Date

Oct 1, 2018Actual

Completion Date

Oct 15, 2018Actual

First Submitted Date

Jan 14, 2018

First Submission Date that Met QC Criteria

Jan 19, 2018

First Posted Date

Jan 26, 2018Actual

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

Dec 3, 2018

Last Update Posted Date

Dec 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Patients undergoing bariatric surgery will be divided randomly into two groups: the first will have TAP block upon completion of surgery and the second groups will not have TAP block.

Detailed Description

Upon completion of the laparoscopic bariatric procedure to be performed for every patient and just before recovery from general anesthesia, an ultrasound-guided TAP block will be conducted in the operative theater by the anesthetist for group I patients whereas group II will be recovered from anesthesia without having a TAP block.

The ultrasound probe will be placed on the lateral abdominal wall in the mid-axillary line between the lower costal margin and iliac crest. Using ultrasound will allow accurate deposition of the local anesthetic in the correct neurovascular plane. A spinal needle will be advanced using in-plane technique between the aponeurosis of the internal oblique and transversus abdominis muscles. With intermittent aspiration, 20 mL of local anesthetic (0.25% bupivacaine) will be deposited in the TAP on each side and seen as a hypoechoic shadow pushing the two layers apart.

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

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TAP block	Active Comparator	Patients undergoing bariatric surgery having TAP block upon completion of the procedure	Procedure: TAP block Procedure: Bariatric surgery
Non TAP block	Sham Comparator	Patients undergoing bariatric surgery without having TAP block	Procedure: Bariatric surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAP block	Procedure	Injection of 20 mL of 0.25% bupivacaine in the transversus abdominis plane under ultrasound guidance after performing bariatric surgery	TAP block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative abdominal pain	Degree of postoperative pain measured by Visual Analogue Scale from 0-10	first 24 hours after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All morbidly obese patients of both genders with BMI >35 kg/m2 who will be admitted to the General Surgery Department within the study period to undergo laparoscopic bariatric procedures will be included in this study. Bariatric procedures to be performed will comprise LSG, roux en-Y- gastric bypass, mini-gastric bypass, gastric plication, and single anastomosis sleeve ileal (SASI) bypass.

Exclusion Criteria:

Patients unfit for general anesthesia, patients with secondary obesity due to endocrine disorders, patients with psychiatric disorders, patients with drug abuse or history of opioid intake or chronic pain disorder, patients with contraindication to peripheral nerve block such as allergy to local anesthetics and coagulopathy.

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

Not provided

Overall Officials

Name	Affiliation	Role
Sameh H Emile, M.D.	Mansoura University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura university hospital		Al Mansurah	Dakahlia Governorate		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
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050110	Bariatric Surgery

Ancestor Terms

ID	Term
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Double

Masking Description

Patients will sign an informed consent entailing their knowledge and acceptance of being included in the trial, however patients will not be aware to the group they will be included to. In addition, the operating surgeon will not be aware to the nature of the study.

Who Masked

ParticipantCare Provider