Evaluation the effect of intraperitoneal bupivacaine with oral clonidine on reduction of abdominal pain after laparoscopic cholecycectomy
Design
patients in group1 recieve intraperitoneal normal salin as placebo
patients in group2 recieve intrapetitoneal bupivacaine
patients in group3 recieve intraperitoneal bupivacaine and oral clonidine
Settings and conduct
study was done in Emam hospital of sari. patients and surgeon was blinded to the study
Participants/Inclusion and exclusion criteria
iclusion criteria:
patients between 18-65 years old with cholecyctitis or symptomatic cholelitiasis
exclusion criteria:
allergy history to anesthetic drug
severe cardiac dsease
lung disease
conversion to open cholecyctectomy
Intervention groups
patients in group1 recieve intraperitoneal normal salin as placebo
patients in group2 recieve intrapetitoneal bupivacaine
patients in group3 recieve intraperitoneal bupivacaine and oral clonidine
Main outcome variables
abdominal pain
shoulder pain
nausia and vomiting
pain killer consumtion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180424039401N1
Registration date:2018-05-25, 1397/03/04
Registration timing:retrospective
Last update:2018-05-25, 1397/03/04
Update count:0
Registration date
2018-05-25, 1397/03/04
Registrant information
Name
farzad mokhtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3324 4496
Email address
farzad_mokhtari_s@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2018-05-21, 1397/02/31
Actual recruitment start date
2017-12-21, 1396/09/30
Actual recruitment end date
2018-05-21, 1397/02/31
Trial completion date
empty
Scientific title
comparison of the effectiveness of intraperitoneal bupivacaine with clonidine on reduction of pain after laparoscopic cholecyctectomy
Public title
evaluation of effect of bupivacaine and clonidine on pain control after laparoscopic cholecyctectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients bethween 18-65years old with cholecyctitis
patients bethween 18-65years old with symptomatic cholelithiasis
Exclusion criteria:
patients with Allergy history to the aneshtetic agent
severe cardiac disease
severe lung disease
patients with conversion to open cholecystectomy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
78
Actual sample size reached:
78
Randomization (investigator's opinion)
Randomized
Randomization description
patient selection will do by pick a card from a boxe with 78card . 26card with for group1, 26kard for group2 and 26card fot group3. surgeon and patients are blined to the study
Blinding (investigator's opinion)
Double blinded
Blinding description
patients selection will carry by head nurse with pick up a card from a box with three type card(nubmer1, number2 and number3).
patients and general surgeon are blinded to the patients group. oral drug or placebo will give to the patients by head nurse before surgery. intraperitoneal drug or placebo will manage by anesthesiologist
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mazandaran University of Medical Sciences
Street address
amirmazandarani street
City
sari
Province
Mazandaran
Postal code
4817843685
Approval date
2018-03-18, 1396/12/27
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1396.1669
Health conditions studied
1
Description of health condition studied
acute cholecystitis
ICD-10 code
K80.0
ICD-10 code description
Calculus of gallbladder with acute cholecystitis
2
Description of health condition studied
chronic cholecystitis
ICD-10 code
K80.10
ICD-10 code description
Calculus of gallbladder with chronic cholecystitis without obstruction
3
Description of health condition studied
cholelithiasis
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
Primary outcomes
1
Description
abdominal pain
Timepoint
1 hour after operation. 6 hour after operation. 24 hour after operation