The objective of this study is to compare the post-operative analgesic efficacy of
ultrasound guided transversus abdominis plane (TAP) block versus intra-thoracic epidural
catheter in patients undergoing abdominal laparotomy.
Design
A non blinded, Quasi experimental interventional, single center study with two intervention groups carried out from march 2023 to September 2023.
Settings and conduct
The study was conducted in Anesthesia Department of Combined Military Hospital, Rawalpindi.
Participants/Inclusion and exclusion criteria
Inclusion criteria included all ASA-I and II male and female patients between ages 20-60 years
presenting for elective or emergency abdominal laparotomy.
Exclusion criteria included patients with cancer, tumors or metastatic disease, low ejection
fraction, respiratory compromise, post chemotherapy, allergic to bupivacaine or lignocaine or
unwilling to be included in the study, infection at site of block, coagulation disorders, patchy or
failed epidural insertion and failure to perform TAP block after three unsuccessful attempts.
Intervention groups
The patients were divided into the TAP block group (Group TAP) (n=60) and the epidural group (Group Epidural)
(n=60).
Main outcome variables
Primary variable observed was mean time to first rescue analgesia and
objective patient satisfaction in both groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230829059295N1
Registration date:2023-09-08, 1402/06/17
Registration timing:registered_while_recruiting
Last update:2023-09-08, 1402/06/17
Update count:0
Registration date
2023-09-08, 1402/06/17
Registrant information
Name
Haroon Tariq
Name of organization / entity
Combined military hospital Rawalpindi
Country
Pakistan
Phone
+92 323 7399976
Email address
haroontariq299@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-30, 1402/01/10
Expected recruitment end date
2023-09-30, 1402/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic efficacy between transversus abdominis plane block and epidural following abdominal surgery
Public title
Comparison of trasnversus abdominis plane block and epidural in abdominal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All ASA-I and II patients
Patients between ages 20-60 years
Patients undergoing for elective or emergency abdominal laparotomy.
Exclusion criteria:
Patients with cancer, tumors or metastatic disease, low ejection fraction, respiratory compromise, post chemotherapy and coagulation disorders,
Allergic to bupivacaine or lignocaine
Unwilling to be included in the study
Patchy or failed epidural insertion and failure to perform TAP block after three unsuccessful attempts.
Infection at site of block
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery method was used for randomization of patients in to two groups i.e One group that received TAP block and the other that had epidural anesthesia. Allocation concealment was not done.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of combined military hospital
Street address
Tamizudin road , lalkurti rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2023-03-30, 1402/01/10
Ethics committee reference number
CMH/RWP/402
Health conditions studied
1
Description of health condition studied
Post operative pain relief after abdominal surgeries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patient satisfaction regarding post operative pain
Timepoint
At 24 hours
Method of measurement
Likert Scale
Secondary outcomes
1
Description
adverse effects of analgesia
Timepoint
Within 24 hours
Method of measurement
Patient's subjective complaints
2
Description
Effect on HDU stay due to pain
Timepoint
24 hrs, 36hrs, 48 hrs
Method of measurement
Duration of admission in HDU
Intervention groups
1
Description
Intervention group: Transversus Abdominis Plane (TAP) Block group. In the TAP block group (n=60), once the surgery was completed, a pain consultant performed the block under ultrasound guidance using standard technique furnished by NYSORA 11 . Bilateral TAP block was performed in all patients that underwent abdominal surgery and 15 ml of 1%lignocaine with adrenaline was injected on each side of the block..
Category
Treatment - Other
2
Description
Intervention group: Epidural analgesia group. An 18 G Smith epidural catheter Touhy needle was inserted in the epidural group (n=60) by a consultant anesthetist pre-operatively under aseptic measures with patient in the sitting position in the T6 thoracic space. Confirmation of correct placement was checked by hanging drop method and further confirmed by test dose of 5 ml 2% lignocaine with adrenaline. Once correct placement was confirmed, the catheter was secured, and surgery was started. No bolus dose of epidural was till the surgery was completed. At the end of surgery, a top-up of 10 ml of0.125% bupivacaine was given in the epidural catheter for post-op analgesia and pain relief.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital
Full name of responsible person
Dr Haroon Tariq
Street address
Tamizzudin road, Lalkurti, Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 51 9273426
Email
haroontariq299@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined military hospital
Full name of responsible person
Dr Rashid Iqbal
Street address
tamizudin road, lalkurti rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 51 9273423
Email
haroontariq299@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Combined military hospital
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Combined Military Hospital
Full name of responsible person
Haroon Tariq
Position
Post graduate resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
House No 318, Street 5, Sector B1, DHA Phase 1, Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 323 7399976
Email
haroontariq299@gmal.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined Military Hospital
Full name of responsible person
Haroon Tariq
Position
Post graduate resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
House No 318, Street 5, Sector B1, DHA Phase 1, Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 323 7399976
Email
haroontariq299@gmal.com
Person responsible for updating data
Contact
Name of organization / entity
Combined military hospital Rawalpindi
Full name of responsible person
Haroon Tariq
Position
Resident anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
House 318 ,Street 5, sector B1 , DHA phase one Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 323 7399976
Fax
Email
haroontariq299@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected data could be provided
When the data will become available and for how long
Data will be available for 2 years starting from October 2023 to October 2025
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
Interventionaal studies being done on the same topic
From where data/document is obtainable
haroontariq299@gmail.com
What processes are involved for a request to access data/document
Please contact on the email provided to ask for detailed data