Comparison of the analgesic efficacy of intraperitoneal bupivacin with intraperitoneal irrigation with bicarbonate following laparoscopic cholecystectomy
Comparison of the analgesic efficacy of intraperitoneal bupivacaine with intraperitoneal irrigation with bicarbonate following laparoscopic cholecystectomy
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
This study will be done in Rasool Akram hospital. Samples will be selected randomly. Researcher, analyzer and collector of samples do not be aware about the type of interventions . Patients aged 17 to 60 years old who are candidate for laparoscopic cholecystectomy with inclusion criteria such as lack of patients consent, addiction, allergic reaction, drug or alcohol abuse, chronic pain disorders, treating with steroids and conversion of laparoscopic cholecystectomy to open surgery. All surgeries will be performed by one surgeon .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 17 to 60 years old who are candidate for laparoscopic cholecystectomy. Exclusion criteria: Lack of patients consent, Opium use 24 hours before study, allergic reaction to each of study drugs, drug and alcohol abuse
Intervention groups
In this study, we will compare the two groups receiving intervention and one group receiving normal saline, so that the irrigation of the first intervention group will be done with bicarbonate 7.5 % intrapritoneal. Intervention group will receive 50 ml of bupivacaine 0.2% that is spread in bed of gallbladder .Control group only is irrigated intrapritoneal with normal saline
Main outcome variables
Pain following laparoscopic cholecystectomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180723040570N1
Registration date:2019-06-24, 1398/04/03
Registration timing:retrospective
Last update:2019-06-24, 1398/04/03
Update count:0
Registration date
2019-06-24, 1398/04/03
Registrant information
Name
Nasim Nikoubakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 9854
Email address
nikoobakht.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
2017-07-23, 1396/05/01
Actual recruitment end date
2018-07-23, 1397/05/01
Trial completion date
2019-08-22, 1398/05/31
Scientific title
Comparison of the analgesic efficacy of intraperitoneal bupivacin with intraperitoneal irrigation with bicarbonate following laparoscopic cholecystectomy
Public title
Comparision of analgesia in postoperation painof cholesystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consent
Cholesystectomy for first time
Exclusion criteria:
Absence of addiction during 24 hours before surgery
Absence of allergic reaction to drugs
Absence of addiction of alcohol and drugs
Absence of chronic pain disorder
Absence of neurological disease or chronic usage of steroids
Age
From 17 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by random allocation software
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, main researcher, a person who collects the data, analizor do not know about intervention and type of groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat ave.Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-06-10, 1397/03/20
Ethics committee reference number
IR.IUMS.REC 1396.32506
Health conditions studied
1
Description of health condition studied
cholesystectomy
ICD-10 code
K81.0
ICD-10 code description
Acute cholecystitis
Primary outcomes
1
Description
Pain that means anything bothers patients physically and mentally
Timepoint
Ricovery and 2,8,24 hours after surgery
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: surgeon irrigates incision region and anastomosis with bupivacaine 0.2%through laparoscopy port then he waits 3 minutes and he empties gas intra abdominal completely
Category
Treatment - Drugs
2
Description
Intervention group: surgeon irrigates abdomen with 7.5 %bicarbonate in 1000 cc normal saline intraperitoneally . he changes patient position to right and left lateral , trendelenburg then supine so all of areas of peritoneum are irrigated. he waits 3 minutes then he empties intra abdominal gas and liquid.
Category
Treatment - Drugs
3
Description
Control group: Intraperitoneal irrigation with normal saline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoolakram hospital
Full name of responsible person
Nasim nikoobakht
Street address
Hemmat Ave.Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1000
Email
nnikobakht@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasimnikoobakht
Street address
Hemat ave.Iranuniversity of medical sciences
City
TEHRAN
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1000
Email
nnikobakht@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Nasim nikoobakht
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hemat ave.Iranuniversity of medical sciences
City
TEHRAN
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1000
Email
nnikobakht@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasim nikoobakht
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hemmat Ave.Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1000
Email
nnikobakht@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasim nikoobakht
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hemat ave.Iranuniversity of medical sciences
City
TEHRAN
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1000
Email
nnikobakht@yahoo.com
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All documents
When the data will become available and for how long
One year after publication
To whom data/document is available
researchers of univercity
Under which criteria data/document could be used
All of analysyses
From where data/document is obtainable
Email :nnikobakht@yahoo.com
Tel:00989125300531
What processes are involved for a request to access data/document
After your request through email I answer it during one month