The effect of 2 grams vitamin C single dose IV injection compare with 20 ml of normal saline injection half an hour before laparoscopic cholecystectomy in pain and the patient's postoperative total opium usage in Shariati Hospital in 1393
In order to understand the effect of vitamin C injection before surgery in pain control of the patients, 110 patients who are not drug abuser and are candidate for laparoscopic cholecystectomy are randomizely divided in to two groups. Cases in the intervention group will receive injections of 2 grams of vitamin C before surgery and after anesthesia and then undergo the operation. Cases in the control group will receive 20 ml intravenous normal Saline as placebo before the operation. Drugs and placebos are placed into similar boxes and will be sealed on patient's record. Both surgeon and patient will be unaware of the applied drugs. Chief Physician will perform the analysis of the results meanwhile he himself is unaware of the randomly selected cases receiving the drugs. In recovery room, surgeon will apply Narcotic Fentanyl injection pump (patient-controlled anesthesia) for both groups. Pumps would inject 1 Micro gram Fentanyl every time and will stop injecting for ten minutes afterwards. Total dose of applied Narcotics after six and twenty hours after operation will be extracted from the pump and compared together. Every six hours after operation, Patients’ pain level will be measured by trained nurses using pain-rulers. Existing the nausea and vomiting will be recorded as Yes or No after 6 to 24 hours after the operation for comparison. Patients’ satisfaction form will be completed prior to the patients’ discharge.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013040612918N1
Registration date:2014-09-08, 1393/06/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-09-08, 1393/06/17
Registrant information
Name
Sara Emami
Name of organization / entity
Tehran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 31 5534 3400
Email address
s_emami@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of medicine of Tehran University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 2 grams vitamin C single dose IV injection compare with 20 ml of normal saline injection half an hour before laparoscopic cholecystectomy in pain and the patient's postoperative total opium usage in Shariati Hospital in 1393
Public title
The effect of vitamin C injection before surgery in patient's pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients who are considered for laparoscopic cholecystectomy (Laparoscopic surgery due to biliary Colic or cholecyctitis)
Exclusion Criteria: Patients who are allergic to Narcotics or abusing drugs will be excluded from the study. In the case of necessity for simultaneous surgery, the patient will be excluded from the study. During 24- hour follow-up, Naloxone will be provided for the patients, and if patients’ respiratory rate drops below 12, PCA will be stopped and patient will be excluded from the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and technology center of Tehran University of Medical Siences
Street address
Poorsina street, faculty of medicin of Tehran University of Medical Siences
City
Tehran
Postal code
1417613151
Approval date
2014-03-31, 1393/01/11
Ethics committee reference number
109076
Health conditions studied
1
Description of health condition studied
Cholecystitis
ICD-10 code
k81.9
ICD-10 code description
Cholecyctitis unspecified
2
Description of health condition studied
post op use of opium
ICD-10 code
y45.0
ICD-10 code description
Opioids and related analgesics
3
Description of health condition studied
postoperative pain
ICD-10 code
r 10
ICD-10 code description
abdominal and pelvic pain
4
Description of health condition studied
post operative nausea and vomiting
ICD-10 code
r11
ICD-10 code description
Nausea and vomiting
5
Description of health condition studied
surgical wound infection
ICD-10 code
t81.4
ICD-10 code description
Infection following a procedure, not elsewhere classified
6
Description of health condition studied
calculus of gallbladder
ICD-10 code
k80.0
ICD-10 code description
calculus of gallbladder with acute cholecystitis
7
Description of health condition studied
calculus of ballblader without cholecystitis
ICD-10 code
k80.2
ICD-10 code description
calculus of ballblader without cholecystitis
8
Description of health condition studied
calculus of gallbladder with other cholecystitis
ICD-10 code
k80.1
ICD-10 code description
calculus of gallbladder with other cholecystitis
Primary outcomes
1
Description
amount of opium used
Timepoint
6 and 24 hours after surgery
Method of measurement
patient controlled anesthesia
Secondary outcomes
1
Description
nausea and vomiting
Timepoint
every 6 hours
Method of measurement
visual analoge scale
2
Description
wound infection
Timepoint
after 7 days
Method of measurement
physical examination
3
Description
patient satisfaction
Timepoint
after 24 hours
Method of measurement
sf 12 questionair
4
Description
urinary retention
Timepoint
during 24 hours
Method of measurement
examination
Intervention groups
1
Description
The intervention is one single dose of 2 grams of vitamin c of Osve pharmacological factory that made in IRAN ,that is equal to 4 vials of vitamin c that diluted with normal saline up to 20 cc and intravenously injected in the operation room after general anesthesia
Category
Treatment - Drugs
2
Description
In the control group 20 cc normal saline injected intravenously after general anesthesia before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgery ward of Dr Shariati Hospital
Full name of responsible person
Sara Emami
Street address
North Karegar street, Jalale Al Ahmad Highway, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of medicine of Tehran University of Medical Siences
Full name of responsible person
Hajar Moammaee
Street address
Poorsina street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of medicine of Tehran University of Medical Siences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dr Shariati Hospital, surgery ward
Full name of responsible person
Sara Emami
Position
surgery resident
Other areas of specialty/work
Street address
North Karegar street, Jalal Al Ahmad Highway
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2450
Fax
Email
s_emami@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dr Shariati hospital
Full name of responsible person
Dr Zhamak Khorgami
Position
General surgeon, associate professor
Other areas of specialty/work
Street address
North Karegar street, Jalal Al Ahmad tree way street
City
Tehran
Postal code
Phone
+98 21 8490 2450
Fax
Email
khorgami@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dr Shariati hospital, surgery ward
Full name of responsible person
Sara Emami
Position
surgery resident
Other areas of specialty/work
Street address
North Karegar street, Jallale Al Ahmad highway
City
Tehran
Postal code
Phone
+98 31 5534 3400
Fax
Email
Emami_sareh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)