Comparison of the efficacy of ropivacaine plus ketamine with ropivacaine alone in transversus abdominis plane block for pain control after elective Cesarean section
Design
Phase III non-blinded randomized controlled (without placebo) trial with parallel groups on 54 patients, randomization will be performed using a randomization table generated by the Random Allocation software
Settings and conduct
This study will be performed on 54 candidates for elective Cesarean referred to Shariati hospital, Bandar Abbas. Patients will be randomized into two groups based on a randomization table. In the first group, 20 ml ropivacaine 0.2% for each side with lateral approach under ultrasound guide will be applied for TAP block, and in the second group, in addition to ropivacaine, 0.5 mg/kg ketamine will be administered. At 0, 4, 8, and 12 hours after Cesarean, pain, blood pressure, and heart rate will be evaluated. There will be no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pregnancy, candidacy for elective Cesarean, American Society of Anesthesiologists class I and II, singleton pregnancy
Exclusion criteria: hypersensitivity to ropivacaine, hypersensitivity to ketamine
Intervention groups
Group A: 20 ml ropivacaine 0.2% for each side with lateral approach under ultrasound guide
Group B: 20 ml ropivacaine 0.2% for each side with lateral approach under ultrasound guide plus 0.5 mg/kg ketamine
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221125056605N1
Registration date:2024-03-26, 1403/01/07
Registration timing:registered_while_recruiting
Last update:2024-03-26, 1403/01/07
Update count:0
Registration date
2024-03-26, 1403/01/07
Registrant information
Name
Elahe Soleimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3371 0370
Email address
drelahesoleimani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ropivacaine plus ketamine with ropivacaine alone in transversus abdominis plane block for pain control after elective Cesarean section
Public title
Ropivacaine plus ketamine versus ropivacaine alone for Cesarean pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnancy
Candidacy for elective Cesarean
American Society of Anesthesiologists (ASA) class I and II
Singleton pregnancy
Exclusion criteria:
Hypersensitivity to ropivacaine
Hypersensitivity to ketamine
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized into two groups using simple randomization with individuals as the unit of randomization and a randomization table produced by the Random Allocation software. An individual uninvolved in the study will write A or B on a card and put it in an opaque envelope. Then the associated number in the randomization table will be written on the back of the envelope. One envelope will be allocated to each patient in order of entrance to the study. Allocation concealment will be done using opaque envelopes.
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
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Faculty of Medicine, Across from Kargaran Sports Complex, Imam Hossein Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2023-12-30, 1402/10/09
Ethics committee reference number
IR.HUMS.REC.1402.366
Health conditions studied
1
Description of health condition studied
Elective Cesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
Pain after Cesarean
Timepoint
At 0, 4, 8, and 12 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
At 0, 4, 8, and 12 hours after surgery
Method of measurement
Standard mercury sphygmomanometer
2
Description
Heart rate
Timepoint
Standard mercury sphygmomanometer
Method of measurement
Counting beats per minute
3
Description
The interval to pain onset
Timepoint
After surgery
Method of measurement
Clock
4
Description
The time of first analgesic requirement
Timepoint
After surgery
Method of measurement
Clock
5
Description
The amount of required analgesic
Timepoint
Within 24 hours of surgery
Method of measurement
Mg analgesic used
Intervention groups
1
Description
Intervention group: 20 ml ropivacaine 0.2% with lateral approach under ultrasound guide at both sided for transversus abdominis plane block (manufactured by Molteni Co., Italy)
Category
Prevention
2
Description
Intervention group: Intervention group: 20 ml ropivacaine 0.2% with lateral approach under ultrasound guide at both sides for transversus abdominis plane block (manufactured by Molteni Co., Italy) plus 0.5 mg/kg ketamine (manufactured by Rotexmedica Co., Germany)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital, Bandar Abbas
Full name of responsible person
Elahe Soleimani
Street address
Dr. Ali Shariati Hospital, Shahid Naser Blvd., Next to the Revolutionary Court, Bandar Abbas, Hormozgan
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 5934
Email
drelahesoleimani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery for Research Hormozgan University of Medical Sciences
Full name of responsible person
Teamur Aghamolaei
Street address
Across from Kargaran Sports Complex, Imam Hossein Blvd., Bandar Abbas, Hormozgan
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0393
Email
teaghamolaei@gmail.com
Web page address
https://resv.hums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery for Research Hormozgan University of Medical Sciences
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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Elahe Soleimani
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Mohammadi Hospital, Jomhouri Eslami Blvd., Bandar Abbas, Hormozgan
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
drelahesoleimani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Elahe Soleimani
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Mohammadi Hospital, Jomhouri Eslami Blvd., Bandar Abbas, Hormozgan
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
drelahesoleimani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Elahe Soleimani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Faculty of Medicine, Imam Hossein Blvd., Bandar Abbas, Hormozgan
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3371 0370
Fax
Email
drelahesoleimani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD