Comparison of the effect of intraperitoneal ropivacaine with the combination of ropivacaine and dexmedetomidine in reducing pain after sleeve gastrectomy
Comparison of the effect of intraperitoneal ropivacaine with the combination of ropivacaine and dexmedetomidine in reducing pain after sleeve gastrectomy
Design
Randomized controlled clinical trial with parallel groups, double-blind, phase 3 on 48 patients. Randomization will be done by block method and using the sequence provided by Random Generator software.
Settings and conduct
This clinical trial will be conducted on eligible patients in the general operating room of Sina Hospital (Tehran University of Medical Sciences).Eligible patients are randomly assigned to one of the study groups and receive the desired intervention.The intensity of pain, nausea and vomiting after anesthesia and the dose of narcotic required for recovery will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:The patient is a candidate for bariatric laparoscopic surgery;The patient's age is over 18 years;The patient is classified as ASA class 1 to 3 according to the American Society of Anesthesiologists.
Exclusion criteria:The patient has an opioid addiction;The patient has a previous history of abdominal surgery;The patient has a history of allergy to any of the drugs under study.
Intervention groups
After the completion of the surgical incision and before the removal of the surgical trocar, it is sprayed intraperitoneally in the area of the esophageal hiatus and the gastric surgical incision within two minutes, according to the type of the desired intervention group.
Intervention group 1: (ropivacaine 0.5% 20ml + normal saline up to the final volume of 40ml),intraperitoneally
Intervention group 2: (ropivacaine 0.5% 20 ml + dexmedetomidine 1 μg/kg + normal saline up to the final volume of 40 ml),intraperitoneally
Control group: normal saline 40ml,intraperitoneally
Main outcome variables
Pain intensity based on the VAS scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151221025641N6
Registration date:2023-03-30, 1402/01/10
Registration timing:prospective
Last update:2023-03-30, 1402/01/10
Update count:0
Registration date
2023-03-30, 1402/01/10
Registrant information
Name
Parisa Kianpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2660 2854
Email address
pk.pioneer1@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2024-03-10, 1402/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intraperitoneal ropivacaine with the combination of ropivacaine and dexmedetomidine in reducing pain after sleeve gastrectomy
Public title
Comparison of the effect of intraperitoneal ropivacaine with the combination of ropivacaine and dexmedetomidine in reducing pain after sleeve gastrectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is a candidate for bariatric laparoscopic surgery;
The patient's age is over 18 years;
The patient is classified as ASA class 1 to 3 according to the American Society of Anesthesiologists;
Exclusion criteria:
The patient has an opioid addiction;
The patient has a previous history of abdominal surgery;
The patient has a history of allergy to any of the drugs under study.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the block method and 6 blocks including the intervention and control groups will be used. The preparation of randomization sequences is done using the Random Generator software, and the created sequences will be available to a trained staff person who is not a member of the research group, and other people will be unaware of the sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient and the researchers are unaware of the type of analgesic intervention received during surgery.A trained staff (anesthetist) who is not a member of the research group will prepare the medicinal solution according to the randomization sequence and will be provided to the researcher.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central building, Ghods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1913914435
Approval date
2022-05-31, 1401/03/10
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1401.023
Health conditions studied
1
Description of health condition studied
Sleeve gastrectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity
Timepoint
On 0,2,4,8,12,24 hours
Method of measurement
VAS scale
Secondary outcomes
1
Description
Opioid dosage requirement
Timepoint
On 0,2,4,8,12,24 hours
Method of measurement
Medical record
2
Description
Post anesthetic nausea and vomiting
Timepoint
On 0,2,4,8,12,24 hours
Method of measurement
Patient examination
Intervention groups
1
Description
Intervention group: ropivacaine 0.5% 20ml + normal saline up to the final volume of 40ml, intraperitoneally
Category
Treatment - Drugs
2
Description
Intervention group: ropivacaine 0.5% 20 ml + dexmedetomidine 1 μg/kg + normal saline up to the final volume of 40 ml, intraperitoneally
Category
Treatment - Drugs
3
Description
Control group: normal saline 40ml,intraperitoneally
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Mohammadreza Neishaboury
Street address
Sina hospital; Hasan abad Sq., Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
+98 21 6312 0000
Email
mrneishaboury@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central building, Ghods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1913914435
Phone
+98 21 8163 1000
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
30
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
2
Sponsor
Name of organization / entity
Anesthesiology, critical care and pain management research center
Full name of responsible person
Farhad Etezadi
Street address
Sina hospital, Hasan abad sq., Imam khomeini Ave.
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
+98 21 6312 0000
Email
accpm.rc.tums@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Anesthesiology, critical care and pain management research center
Proportion provided by this source
70
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
Tehran University of Medical Sciences
Full name of responsible person
Samira Shokri
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Sina hospital, Hasan abad sq., Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
+98 21 6312 0000
Email
mrneishaboury@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Neishaboury
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina hospital, Hasan abad sq., Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
+98 21 6312 0000
Email
mrneishaboury@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samira Shokri
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Sina hospital, Hasan abad sq., Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
+98 21 6312 0000
Email
mrneishaboury@tums.ac.ir
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