Investigate the Effect of Interaperitoneal ketamin plus bupivacaine administration for pain relief laparascopic cholecystectomy and comparison with bupivacaine alon
Comparison of postoperative pain intensity in the studied groups
2) Comparison of the use of painkillers in the studied groups
3) Check and compare blood pressure in the studied groups before and after the intervention4) Examination and comparison of heart rate in the studied groups before and after the intervention5) Investigation of nausea and vomiting in the studied groups after the intervention6) Check the time required for painkillers in the studied groups after the intervention
Design
Study of clinical trial of two randomized double-blind sockets with phase 1-2, which has a control group. The relationship between the groups is parallel.Ninety patients undergoing laparoscopic elective cholecystectomy were randomly divided into three groups with random allocation software
Settings and conduct
Peritoneal solutions are injected into the liver bed after the gallbladder is removed. For group one, a combination of bupivacaine and ketamine , for the second group bupivacaine and For the third group, saline is injected in equal volumes to evaluate the effect of these solutions on the shoulder pain with a VAS scale. This study was two-way blind that the study participant and the person registering the variables were unaware of the study.
Participants/Inclusion and exclusion criteria
Be Elective laparoscopic cholecystectomy
Age between 18 and 65 years
• Weight between 55 and 100 kg
• The duration of surgery is less than two hours.
Intervention groups
in group one, the combination of ketamine and bupivacaine, and in the second group, only bupivacaine, and in the control group, normal saline is injected into the peritoneum, in the liver bed, after separation of the gallbladder.
Main outcome variables
Shoulder pain score after laparoscopic surgery on Visual Analog Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200513047418N1
Registration date:2020-06-02, 1399/03/13
Registration timing:retrospective
Last update:2020-06-02, 1399/03/13
Update count:0
Registration date
2020-06-02, 1399/03/13
Registrant information
Name
Parvin Ziaiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3265 3741
Email address
p.ziaiei@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-01, 1398/04/10
Expected recruitment end date
2020-01-30, 1398/11/10
Actual recruitment start date
2019-12-01, 1398/09/10
Actual recruitment end date
2020-03-05, 1398/12/15
Trial completion date
2020-03-05, 1398/12/15
Scientific title
Investigate the Effect of Interaperitoneal ketamin plus bupivacaine administration for pain relief laparascopic cholecystectomy and comparison with bupivacaine alon
Public title
Evaluation of the effect of ketamine and bupivacaine combination on shoulder pain after gallbladder surgery by laparoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
elective laparascopic cholecystectomy
age 18 -65 year
weight 55-100 kg
The duration of surgery is less than two hours.
No neurovascular disease, coagulation disorders, cardiovascular disease • No history of ketamine and bupivacaine allergy
No history of abdominal surgery
Exclusion criteria:
use of alcohol, painkillers and anti-inflammatory and non-steroidal anti-inflammatory drugs
Having chronic pain unrelated to gallbladder disease
Dissatisfaction of the patient to continue participating in this study
he need for laparotomy during laparoscopy
having acute cholecystitis
People who could not understand VAS.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
For simple randomization, numbers 1-30 were considered for group one intervention, numbers 31-60 for group tow intervention, and numbers 61-90 for group three intervention were considered. Using computer software, sequences of random numbers were creat in the numerical range 1-90. The numbers were recorded and assigned to one of the three groups based on the numerical range defined by each group. hen a card was prepared according to the number of samples and on them was written one of the numbers 1,2,3 that represented the type of group. Based on the created sequence, the card for each group was placed in similar envelopes and arranged in a box. In order to maintain a random sequence, numbering was performed on the outer surface of the envelopes, respectively. fter obtaining the patient's consent, one of the letters was opened and the patient's group was identified based on the card number. The random allocation was hidden by the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
An evaluator of study variables is the ward nurse who was unaware of the type of study and the subject of the study as well as the type of medication the patients received. Patients were unaware of their group and the medication they should receive And they were told that they were in one of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
no have
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Alam Square,. Shahid Sadoughi University of Medical Sciences Campus,. Yazd - Faculty of Health.
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2019-07-29, 1398/05/07
Ethics committee reference number
IR.SSU.SPH.REC.1398.046
Health conditions studied
1
Description of health condition studied
Shoulder pain after laparoscopic surgery
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
The severity of shoulder pain after laparoscopic surgery on (Visual Analogue Scale)
Timepoint
Two, four, six, eight hours after surgery
Method of measurement
Visual Analogue Scale(VAS)
Secondary outcomes
1
Description
Hypotension, pressure drop above 20% initial value
Timepoint
An hour before surgery and two, four, six, eight hours after laparoscopic cholecystectomy
Method of measurement
By a sphygmomanometer
2
Description
Number of heartbeats
Timepoint
An hour before surgery and in 2-4-6-8 hours after surgery
Method of measurement
By counting the number of pulses per minute that is recorded in the checklist.
3
Description
Dosage of analgesics
Timepoint
8 hours after surgery
Method of measurement
Using a syringe, it is registered in the checklist in milligrams.
4
Description
The first time analgesics are needed
Timepoint
8 hours after surgery.
Method of measurement
It is registered in the checklist and based on the minute.
5
Description
nausea and vomiting
Timepoint
2-4-6-8 hours after surgery
Method of measurement
View and ask .By options has and does not have in the checklist
Intervention groups
1
Description
Intervention group: In this group, 10 cc of bupivacaine 0.5% is combined with 0.5 mg / kg of ketamine, and with a normal saline of 0.9%, the volume of the drug reaches 20 cc.The compound is injected into the peritoneum at the end of the surgery and after the gallbladder is removed.
Category
Prevention
2
Description
Intervention group: In the second group, 10 cc of bupivacaine 0.5% with 10 cc of normal saline 0.9%, reaches a volume of 20 cc, and at the end of surgery and after removing the gallbladder, is injected into the peritoneum at the site of surgery.
Category
Prevention
3
Description
Control group: 20 cc of normal saline is injected into the peritoneum as a placebo at the end of surgery and after removal of the gallbladder.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr. Hossein Soleimani Salehabadi
Street address
Shahid Sadough Hospital ., Ibn Sina St., Shahid Ghandi Blvd., Safaieh
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 1822 4000
Fax
+98 35 1822 4100
Email
Sadoghi-hospital@ssu.ac.ir
Web page address
https://web.ssu.ac.ir/index.aspx?lang=1&sub=16
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Massoud Mirzaei
Street address
the central building of Yazd University of Medical Sciences., Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
Web page address
https://web.ssu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Parvin Ziaiei
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
NO. 30 , Saadi Lane., Saadi Cross., Eastern Hasht Behesht Ave.,
City
Esfahan
Province
Isfehan
Postal code
81579-55981
Phone
+98 31 3265 3741
Email
p.ziaiei@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Saeed Kargar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Sadoughi Hospital., Ibn Sina St., Shahid Ghandi Blvd
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 4000
Email
saeedkargar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Parvin Ziaiei
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
NO. 30 , Saadi Lane., Saadi Cross., Eastern Hasht Behesht Ave.,
City
Esfahan
Province
Isfehan
Postal code
81579-55981
Phone
+98 31 3265 3741
Email
p.ziaiei@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All potential data can be shared after people have not been identified.
When the data will become available and for how long
Start the course after publishing the results
To whom data/document is available
For researchers at academic and scientific institutions
Under which criteria data/document could be used
The applicant's academic resume is required.
From where data/document is obtainable
They can contact us by email: p.ziaiei@ssu.ac.ir
What processes are involved for a request to access data/document
The person receives the data by sending his / her scientific resume for a maximum of 3 months.