Comparative Study between ultrasound guided transversalis fascia plane block and transversus abdominis plane block on postoperative pain relief in patients undergoing elective cesarean section
Aim: Comparative Study between ultrasound guided transversalis fascia plane block and transversus abdominis plane block on postoperative pain relief in patients undergoing cesarean section. Design: a randomized, one-blind, single-center, phase II clinical trial. Patients undergoing cesarean section surgery are divided into two groups: ultrasound guided transversalis fascia plane block and transversus abdominis plane block for decrease the postoperative pain. Pain score will be recorded during rest and coughing after block. The main inclusion criteria included patients undergoing cesarean section surgery. Exclusion criteria included patients EMR Patients with organic problem. Patients were divided into two groups ultrasound guided transversalis fascia plane block and transversus abdominis plane block. The main outcome variables: Pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072210599N18
Registration date:2017-11-03, 1396/08/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-03, 1396/08/12
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
p-rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-08-09, 1396/05/18
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study between ultrasound guided transversalis fascia plane block and transversus abdominis plane block on postoperative pain relief in patients undergoing elective cesarean section
Public title
Effect of abdominal nerves block on cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients Undergoing cesarean section. Exclusion criteria: EMR Patients with organic problem; history of hypersensivity to bupivacaine; Patients with BMI more than 40; Patients who received analgesia previous day; history of liver problem or kidney disease or coagolopaty.
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done using the blocking method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
tehran
Postal code
Approval date
2016-05-24, 1395/03/04
Ethics committee reference number
IR.IUMS.REC 1395.9311174011
Health conditions studied
1
Description of health condition studied
caesarean section
ICD-10 code
082
ICD-10 code description
Single delivery by caesarean section
Primary outcomes
1
Description
Pain
Timepoint
2, 4, 18, 24, 36 after block at rest and cough
Method of measurement
Based on VAS visual criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 2: Abdominal transversal muscle block method is administered under ultrasound guidance.
Category
Other
2
Description
Intervention 1: Transcortical facial block method is administered under the guidance of cesognography.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasoul Akram Hospital
Full name of responsible person
Dr Poupak Rahimzadeh
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Poupak Rahimzadeh
Position
Ph.D. Medical Anesthesiology / Associate Professor
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
+216 6509059
Email
poupak_rah@hotmail.com; prahimzadeh@ tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Poupak Rahimzadeh
Position
Ph.D. Medical Anesthesiology / Associate Professor
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
+98 21 6650 9059
Email
poupak_rah@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Masoumeh Rahimian Jahromi
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
+98 21 6650 9059
Email
rahimianmasoume@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)