: The objective of this study is to compare and observe the post-operative analgesic efficacy of ultrasound guided transversalis fascia plane (TFPB) block when compared with anterior quadratus lumborum (QL) block in patients undergoing caesarian section.
Design
Prospective observational study
Settings and conduct
Prospective observational study
Participants/Inclusion and exclusion criteria
incluson criteria included all ASA-I and II female patients presenting for elective caesarian with a gestational age of more than 38 weeks to be done by Pfannenstiel incision under general anesthesia.
Exclusion criteria excluded patients with metastatic disease, major cardiac or respiratory disease, low ejection fraction, post chemotherapy, major coagulopathy and unwilling to be included in the study
Intervention groups
Both blocks were done bilaterally under ultrasound guidance following the standard aseptic techniques and protocols furnished by NYSORA at the end of surgery under general anesthesia. Primary variables measured were mean total 24-hour morphine consumption and median scores on the NRS scale at 3-, 6-, 12- and 24-hours interval
Main outcome variables
post operative analgesia in patients undergoing cesarian section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230809059101N1
Registration date:2023-08-28, 1402/06/06
Registration timing:retrospective
Last update:2023-08-28, 1402/06/06
Update count:0
Registration date
2023-08-28, 1402/06/06
Registrant information
Name
Muzzamal Saleem
Name of organization / entity
Combined military hospital bahawalpur
Country
Pakistan
Phone
+92 62 2501714
Email address
muzzamal79@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-01, 1401/10/11
Expected recruitment end date
2023-06-30, 1402/04/09
Actual recruitment start date
2023-01-01, 1401/10/11
Actual recruitment end date
2023-06-30, 1402/04/09
Trial completion date
2023-06-30, 1402/04/09
Scientific title
ANALGESIC EFFICACY OF TRANSVERSALIS FASCIA PLANE BLOCK VERSUS ANTERIOR QUADRATUS LUMBORUM BLOCK AFTER CAESARIAN SECTION
Public title
ANALGESIC EFFICACY OF BLOCKS AFTER CAESARIAN SECTION
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
included all ASA-I and II female patients presenting for elective caesarian with a gestational age of more than 38 weeks to be done by Pfannenstiel incision under general anesthesia.
Exclusion criteria:
excluded patients with metastatic disease, major cardiac or respiratory disease, low ejection fraction, post chemotherapy, major coagulopathy and unwilling to be included in the study.
Age
From 22 years old to 28 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
non-probability consecutive sampling
Blinding (investigator's opinion)
Double blinded
Blinding description
non-probability consecutive sampling
Placebo
Used
Assignment
Parallel
Other design features
non-probability consecutive sampling
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethical committe combined military hospital bahawalpur
Street address
CMH Bahawalpur
City
Bahawalpur
Postal code
63100
Approval date
2023-01-01, 1401/10/11
Ethics committee reference number
EC-04-2023
Health conditions studied
1
Description of health condition studied
ANALGESIC EFFICACY OF TRANSVERSALIS FASCIA PLANE BLOCK VERSUS ANTERIOR QUADRATUS LUMBORUM BLOCK AFTER CAESARIAN SECTION
ICD-10 code
O75.9Compl
ICD-10 code description
O75.9Complication of labour and delivery, unspecified
Primary outcomes
1
Description
Both blocks were done bilaterally under ultrasound guidance following the standard aseptic techniques and protocols furnished by NYSORA at the end of surgery under general anesthesia. Primary variables measured were mean total 24-hour morphine consumption and median scores on the NRS scale at 3-, 6-, 12- and 24-hours interval.
Timepoint
Primary variables measured were mean total 24-hour morphine consumption and median scores on the NRS scale at 3-, 6-, 12- and 24-hours interval.
Method of measurement
the standard NRS (numerical rating scale) for pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital Bahawalpur
Full name of responsible person
Muhammad Muzzamal Saleem
Street address
CMH Bahawalpur
City
Bahawalpur
Postal code
63100
Phone
+92 62 28874689
Email
muzzamal79@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined Military Hospital Bahawalpur
Full name of responsible person
Muhammad Muzzamal Saleem
Street address
Cantonment area bahawalpur
City
Bahawalpur
Postal code
63100
Phone
+92 62 2887468
Email
muzzamal79@hotmail.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 Bahawalpur
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 Bahawalpur
Full name of responsible person
Muhammad Muzzamal Saleem
Position
consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
cantonment area military hospital bahawalpur
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 62 2887468
Email
muzzamal79@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined Military Hospital Bahawalpur
Full name of responsible person
Muhammad Muzzamal Saleem
Position
consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
cantonment area military hospital bahawalpur
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 62 2887468
Email
muzzamal79@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Combined Military Hospital Bahawalpur
Full name of responsible person
Muhammad Muzzamal Saleem
Position
consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
cantonment area military hospital bahawalpur
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 62 2887468
Email
muzzamal79@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
TABLE-I AGE AND HEIGHT CHARACTERISITICS BETWEEN BOTH GROUPS
TABLE-II COMPARISON OF CUMULATIVE MEAN MORPHINE CONSUMPTION AND MEDIAN NRS SCORES
When the data will become available and for how long
from july 2023 onward
To whom data/document is available
avademic institutions
Under which criteria data/document could be used
applicable
From where data/document is obtainable
muzzamal79@hotmail.com
What processes are involved for a request to access data/document