Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001432808
Ethics application status
Approved
Date submitted
25/12/2020
Date registered
25/10/2021
Date last updated
25/10/2021
Date data sharing statement initially provided
25/10/2021
Date results information initially provided
25/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of Laparoscopically Assisted Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy
Scientific title
Efficacy of Laparoscopically Assisted Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy; A Double Blind, Randomized
Controlled Trial.
Secondary ID [1] 303060 0
nil
Universal Trial Number (UTN)
u1111-1263-0186
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post operative pain 320153 0
Condition category
Condition code
Anaesthesiology 318069 318069 0 0
Pain management
Anaesthesiology 321342 321342 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
transverses abdominus plane block with 20ml of 0.5% Ropivacain (subcostal) intramuscular
surgeon
before closure
as per the per operative difficulty level half hour to upto one and half hour
Intervention code [1] 319345 0
Treatment: Drugs
Comparator / control treatment
group without transverses abdominus plane block (TAP Block)
Placebo (normal saline)
Control group
Placebo

Outcomes
Primary outcome [1] 326075 0
Dosage of nalbuphine by patient's medical record
Timepoint [1] 326075 0
24 hours post surgery
Secondary outcome [1] 390026 0
visual analogue pain score
Timepoint [1] 390026 0
2, 4 ,6 12, 24 hours post surgery

Eligibility
Key inclusion criteria
All the patients undergoing laparoscopic cholecystectomy
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Open Cholecystectomy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation for computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Shapiro Wilk test was used to check the normality of distribution of data. Descriptive statistics were applied for mean age and post operative pain scores at various time intervals. Frequency of gender and additional use of Nalbuphine was determined in both study groups. Mean pain scores were compared between both study groups using Mann Whitney U test while frequency of additional Nalbuphine consumption as per dosage were compared between study groups using Fischer’s Exact Test. P<0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2019
Date of last participant enrolment
Anticipated
Actual
29/02/2020
Date of last data collection
Anticipated
Actual
1/03/2020
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 23346 0
Pakistan
State/province [1] 23346 0
Punjab

Funding & Sponsors
Funding source category [1] 307467 0
Self funded/Unfunded
Name [1] 307467 0
Muhammad Zeeshan Sarwar
Country [1] 307467 0
Pakistan
Primary sponsor type
Individual
Name
Muhammad Zeeshan Sarwar
Address
East Surgical Ward, Surgical Tower, Mayo Hospital, Neela Gumbad, Lahore, Punjab, Pakistan (54000)
Country
Pakistan
Secondary sponsor category [1] 308139 0
Individual
Name [1] 308139 0
Dr. Sadaf Ishaque
Address [1] 308139 0
Assistant Professor ,shalamar hospital, lahore, Punjab,Pakistan. (5400)
Country [1] 308139 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307544 0
Institutional Review Board, Shalamar Medical and Dental College, Lahore, Pakistan
Ethics committee address [1] 307544 0
Shalimar Link Road, Shalimar Larechs Colony, Lahore, Punjab 54000
Ethics committee country [1] 307544 0
Pakistan
Date submitted for ethics approval [1] 307544 0
Approval date [1] 307544 0
21/08/2017
Ethics approval number [1] 307544 0

Summary
Brief summary
Objective:
To analyze the effect of laparoscopically administered Transversus Abdominis Plane (TAP) block on pain scores and opioid consumption in first 24 hours in patients undergoing laparoscopic cholecystectomy.

Hypothesis:
TAP block is better in preventing post operative opioid consumption

Materials & Methods:
A TAP group A received laparoscopic-assisted Transversus Abdominis Plane TAP block with 20 ml 0.5 % Ropivacaine in subcostal region while the Control group B received 20 ml saline solution. Postoperative pain scores at rest and on coughing were recorded using numerical rating scores at 2, 4, 6, 12, and 24 hrs. The primary aim of this study was to compare the Nalbuphine consumption during first 24 h, pain scores at 2, 4, 6,12, 24 hours post surgery
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107614 0
Dr sadaf ishaque
Address 107614 0
Assistant Professor, Shalamar Medical & Dental College, Lahore, Punjab, Pakistan (54000)
Country 107614 0
Pakistan
Phone 107614 0
+92 334 4512939
Fax 107614 0
Email 107614 0
[email protected]
Contact person for public queries
Name 107615 0
Dr Muhammad Zeeshan Sarwar
Address 107615 0
Associate Professor, East Surgical Ward, King Edward Medical University, Mayo Hospital Lahore, Punjab, Pakistan. (54000)
Country 107615 0
Pakistan
Phone 107615 0
+92 322 8420433
Fax 107615 0
Email 107615 0
[email protected]
Contact person for scientific queries
Name 107616 0
Dr Muhammad Zeeshan Sarwar
Address 107616 0
Associate Professor, East Surgical Ward, King Edward Medical University, Mayo Hospital Lahore, Punjab, Pakistan. (54000)
Country 107616 0
Pakistan
Phone 107616 0
+92 322 8420433
Fax 107616 0
Email 107616 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.