To compare whether the use of ultrasonography (USG) is superior to blind landmark technique in correctly identifying epidural space in pregnant patients requesting labor analgesia through epidural catheter
Design
Prospective observational study
Settings and conduct
This prospective observational study was carried out at the Department of Anesthesiology, Combined Military Hospital from after approval from the ethical review board
Participants/Inclusion and exclusion criteria
Inclusion criteria included all ASA I and II patients between 20-35 years of age presenting in labor after achieving term.
Exclusion criteria included patients with history of back pain, surgeries of the spine, on-going medical treatment for backache, patients unwilling to be included in the study, patients with coagulation disorders or on anti-coagulants and BMI greater than 35 kg/m2.
Intervention groups
A total of 250 patients were included in the study protocol divided into Group U (n=125) and Group L (n=125). Primary variables measured were mean number of tries for epidural insertion (taking the needle out and then re-introduction), mean number of needle re-directions (without taking out from skin), difference between actual measured needle length (AML) versus USG measured needle length (UML) and number of dural punctures between the USG and landmark group
Main outcome variables
Primary variables measured were mean number of tries for epidural insertion (taking the needle out and then re-introduction), mean number of needle re-directions (without taking out from skin), difference between actual measured needle length (AML) versus USG measured needle length (UML) and number of dural punctures between the USG and landmark group.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230819059186N1
Registration date:2023-08-25, 1402/06/03
Registration timing:registered_while_recruiting
Last update:2023-08-25, 1402/06/03
Update count:0
Registration date
2023-08-25, 1402/06/03
Registrant information
Name
Syed Aqib Ali Shah
Name of organization / entity
Combined Military Hospital Rawalpindi Punjab pakistan
Country
Pakistan
Phone
+92 51 9273426
Email address
aqibalishahsyed@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-18, 1402/01/29
Expected recruitment end date
2023-10-18, 1402/07/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
THE USE OF ASSISTED PRE-PROCEDURAL ULTRASONOGRAPHY VERSUS LANDMARK TECHNIQUE IN IDENITIFYING EPIDURAL SPACE IN WOMEN REQUESTING LABOR ANALGESIA
Public title
THE USE OF ASSISTED PRE-PROCEDURAL ULTRASONOGRAPHY VERSUS LANDMARK TECHNIQUE IN IDENITIFYING EPIDURAL SPACE IN WOMEN REQUESTING LABOR ANALGESIA
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
included all ASA I and II patients between 20-35 years of age presenting in labor after achieving term.
Exclusion criteria:
patients with history of back pain, surgeries of the spine, on-going medical treatment for backache, patients unwilling to be included in the study, patients with coagulation disorders or on anti-coagulants and BMI greater than 35 kg/m2.
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
250
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee/ institutional review board Combined Military Hospital Rawalpindi
Street address
Street 22 Saddar Rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2023-04-17, 1402/01/28
Ethics committee reference number
429
Health conditions studied
1
Description of health condition studied
Labor Analgesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Primary variables measured were mean number of tries for epidural insertion (taking the needle out and then re-introduction), mean number of needle re-directions (without taking out from skin), difference between actual measured needle length (AML) versus USG measured needle length (UML) and number of dural punctures between the USG and landmark group.
Timepoint
Primary variables measured were mean number of tries for epidural insertion (taking the needle out and then re-introduction), mean number of needle re-directions (without taking out from skin), difference between actual measured needle length (AML) versus USG measured needle length (UML) and number of dural punctures between the USG and landmark group.
Method of measurement
The patients were divided into the ultrasonography group (Group U) (n=125) and the landmark group (Group L) (n=125). Primary variables measured were mean number of tries for epidural insertion (taking the needle out and then re-introduction), mean number of needle re-directions (without taking out from skin), difference between actual measured needle length (AML) versus USG measured needle length (UML) and number of dural punctures between the USG and landmark group.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients in Group L followed the standard blind landmark technique for insertion of the epidural catheter in the L4-L5 space under strict aseptic measures in the procedure room in the sitting position. In case of dural puncture, the space above was then identified and epidural was inserted.
Category
Treatment - Other
2
Description
Intervention group 2: Patients in Group U were also prepped in the recovery room under aseptic measures for the USG procedure. A standard curvy-linear probe was placed and the parasagittal view of the L5-S1 space was identified and L4-L5 space was identified by counting upwards. After correct placement and confirmation of the space, the probe was then rotated, and the transverse view was obtained. Epidural space was then identified between the ligamentum flavum and dural space.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Anesthesia department of Combined Military Hospital, Rawalpindi Punjab Pakistan
Full name of responsible person
Syed Aqib Ali Shah
Street address
22 No Street Saddar Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 51 9273426
Email
aqibalishahsyed@gmail.com
Web page address
https://numspak.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined Military Hospital Rawalpindi Pakistan
Full name of responsible person
Dr Rashid Iqbal
Street address
No. 22 Saddar Rawalpindi
City
Rawalpindi
Postal code
460000
Phone
+92 51 9273426
Email
aqibalishahsyed@gmail.com
Web page address
https://numspak.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Combined Military Hospital Rawalpindi Pakistan
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 Rawalpindi Pakistan
Full name of responsible person
Syed Aqib Ali Shah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 22 Saddar Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 9273426
Email
aqibalishahsyed@gmail.com
Web page address
https://www.numspak.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined Military Hospital Rawalpindi Pakistan
Full name of responsible person
Munim ilyas
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 22 Saddar Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 9273426
Email
aqibalishahsyed@gmail.com
Web page address
https://www.numspak.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
Combined Military Hospital Rawalpindi Pakistan
Full name of responsible person
Dain bin khalid
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 22 Saddar Rawalpindi Pakistan
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 9273426
Email
aqibalishahsyed@gmail.com
Web page address
https://www.numspak.edu.pk/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available