NCT06256302

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

February 1, 2024

Last Update Submit

July 24, 2024

Conditions

Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain score

    Pain score will be evaluated through Visual analogue scale (VAS) score of 0-10cms.

    24 hours of surgery.

Secondary Outcomes (1)

  • Analgesia consumption

    During 24 hours of surgery

Study Arms (2)

Transverses abdominis plane block

EXPERIMENTAL
Procedure: Transverses Abdominis Plane Block

Local wound infiltration

ACTIVE COMPARATOR
Procedure: Local wound infiltration

Interventions

Transverses Abdominis Plane BlockPROCEDURE

Transverses abdominis plane block will be provided randomly using prospective double-blinding.

Transverses abdominis plane block
Local wound infiltrationPROCEDURE

Local wound infiltration will be provided randomly using prospective double-blinding.

Local wound infiltration

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammad Arif

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Arif

    Ziauddin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 13, 2024

Study Start

December 1, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)