Transverses Abdominis Plane Block Versus Local Wound Infi... | NCT06256302

Studies
Transverses Abdominis Plane Block Versus Local Wound Infiltration in Total Abdominal Hysterectomy

NCT06256302

Sponsor

Dr Muhammad Arif

Status

Completed

Last Update Posted

Jul 25, 2024Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Pain

Interventions

Transverses Abdominis Plane Block
Local wound infiltration

Countries

Pakistan

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 2024

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 1, 2023Actual

Primary Completion Date

Feb 28, 2024Actual

Completion Date

Feb 28, 2024Actual

First Submitted Date

Feb 1, 2024

First Submission Date that Met QC Criteria

Feb 12, 2024

First Posted Date

Feb 13, 2024Actual

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

Jul 24, 2024

Last Update Posted Date

Jul 25, 2024Actual

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

To compare the transverses abdominis plane block outcome versus local wound infiltration for postoperative analgesia in patients undergoing total abdominal hysterectomy.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transverses abdominis plane block	Experimental		Procedure: Transverses Abdominis Plane Block
Local wound infiltration	Active Comparator		Procedure: Local wound infiltration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transverses Abdominis Plane Block	Procedure	Transverses abdominis plane block will be provided randomly using prospective double-blinding.	Transverses abdominis plane block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain score	Pain score will be evaluated through Visual analogue scale (VAS) score of 0-10cms.	24 hours of surgery.

Secondary Outcomes

Measure	Description	Time Frame
Analgesia consumption	Patients will be given analgesics only on complain of pain of VAS score of 4 and above.	During 24 hours of surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age range 18 to 50 years
Female
ASA I & II
Undergoing Abdominal Hysterectomy under General anaesthesia

Exclusion Criteria:

Hepatic failure (assessed on clinical signs and symptoms, elevated liver enzymes and ultrasound findings showing loss of normal texture of liver) or renal failure (a GFR of 15 or less)
Allergy or contraindication to study drugs on history
Drug abuse or addiction
Bleeding tendency

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Muhammad Arif	Ziauddin University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Muhammad Arif		Karachi	Sindh		Pakistan

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
D010146	Pain

Ancestor Terms

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

Browse Leaves

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Browse Branches

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