In this study, patients are devided into two randomized groups. The intervention group will be administered 2gr of vit C while the control group will recieve 2gr of Normal Saline serum. Both administrations will take place 60 minutes before induction of anaesthesia. After Performing Laparoscopic cholecystectomy, both Groups will recieve 1gr of Apotel( Paracetamol) every 8 hrs, first dose being administered at recovery room. Furthermore Patients who require more analgesics (VAS>3) will recieve Pethidine(25mg).
The amounts of analgesics ( based on findings in patients dossier), Patients pain score( based on VAS scoring system) in recovery room and 2,6,12 and 24 hrs after the surgery And in addition, Patients Pruritis Nausea vomiting and drowsiness will be Documented in the checklist by the questioner who doesnt know about groups.
In this study, questioner and patient's dont know about groups and drugs,so its a double blind study.
Outcomes of the study will be analyzed by SPSS software based on aforementioned parameters.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051533159N2
Registration date:2017-09-18, 1396/06/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-18, 1396/06/27
Registrant information
Name
Alireza Negahi
Name of organization / entity
Iran university of medical sciences, Rasool Akram hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2215
Email address
negahi.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-08-06, 1396/05/15
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Prophylactic Single Dose of Vitamin C on Postoperative Pain of Laparoscopic Cholecystectomy Surgery.
Public title
effect of pain prevention of vit-C on gallbladder surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:Patients who need Laparascopic Cholecystectomy.
Exclusion Criteria:
1;Patients who dont agree to cooperete in this clinical trial.
2;Patients who have allergy to Pethidine.
3;History of opium addiction.
4;History of sleep Apnea.
5;History of severe Asthma.
6;Patients who refer with acute cholecystitis.
7;Patients who used NSAID in last 24h.
8;Patient who are not Cachectic.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
"Randomization"
A random sequence like AABB-ABAB-...created, and the patient by the number 1-80 will be placed in two same group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Science
Street address
Tehran-Hemmat Highway-Iran University of Medical Science
City
Tehran
Postal code
Approval date
2015-10-23, 1394/08/01
Ethics committee reference number
IR.IUMS.FMD.REC.1394.8921215040
Health conditions studied
1
Description of health condition studied
Calculus of gallbladder without cholecystitis
ICD-10 code
K80.2
ICD-10 code description
Cholecystolithiasis,Cholelithiasis Colic (recurrent) of gallbladder,Gallstone (impacted) of gallbladder.
Primary outcomes
1
Description
postoperative pain.
Timepoint
0-24hrs after surgery.
Method of measurement
pain score( based on VAS scoring system)
Secondary outcomes
1
Description
pruritus
Timepoint
0-24hrs after surgery.
Method of measurement
patient expression with none,slight,intermediate and severe words
2
Description
Nausea
Timepoint
0-24hrs after surgery.
Method of measurement
patient expression with Yes or No.
3
Description
Vomiting
Timepoint
0-24hrs after surgery.
Method of measurement
Patient expression about number of vomitting.
4
Description
consciousness
Timepoint
0-24hrs after surgery.
Method of measurement
1-agitated, 2-cooperate, 3-responsive to orders, 5-slow responsive to stimulation 6-Non Responsive.
Intervention groups
1
Description
intervention group:2gr IV VitC 60 minutes before induction of anaesthesia.
control group:2gr IV Normal Saline 60 minutes before induction of anaesthesia.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Dr Alireza Negahi
Street address
Niayesh street,Sattarkhan street.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Science
Full name of responsible person
Reza Latifian
Street address
Rasool Akram Hospital-Surgery ward
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 Science