This was a double blind randomized clinical trial which performed on 66 patients, ASA I, II who were candidate for laparoscopic cholecystectomy in Imam Reza Hospital, Kermanshah, Iran. The age of patients ranged 20-60 years. Patients with history of Diabetes, acute cholecystit, heart ischemia, former bile ducts surgeries, addiction and sensitivity to local anesthesia drugs were excluded from the study. Patients were divided to two groups: target group and control group. Both groups received the same anesthesia method. Patients in target group were injected 20cc bupivacaine 0.25% ( 20cc vial, Merc Inc) in diaphragm right cavity at the beginning and at the end of operation but control group had no injection. Patients in both groups received 5cc bupivacaine 0.25% through all their incisions on the abdomen, it was the unique point of our study which made it different from all other studies. Patients' pain was assessed by VAS in both two groups every 1 hour for 4 hours after transferring to ward. Their nausea severity was assessed by VAS method too.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810112946N1
Registration date:2010-05-25, 1389/03/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-25, 1389/03/04
Registrant information
Name
Mitra Yari
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6310
Email address
myari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2009-11-22, 1388/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of intraperitoneal bupivacaine on patient's pain relief after laparoscopic cholecystectomy
Public title
Effect of intraperitoneal bupivacaine on pain relief after laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA I, II patients who underwent laparoscopic cholecystectomy. Exclusion criteria: patients with history of Diabetes, acute cholecystitis, heart ischemia, former bile ducts surgeries, addiction and sensitivity to local anesthesia drugs.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
#2 building of medical university, Shahid beheshti boulevard
City
Kermanshah
Postal code
Approval date
2009-03-19, 1387/12/29
Ethics committee reference number
23/j/14678/1
Health conditions studied
1
Description of health condition studied
local anesthesia
ICD-10 code
Y40-Y59
ICD-10 code description
Drugs, medicaments and biological substances causing adverse effects in therapeutic use
Primary outcomes
1
Description
patient pain severity
Timepoint
every 1 hour for 4 hours after transfering to the ward.
Method of measurement
VAS
Secondary outcomes
1
Description
patient's nausa severity
Timepoint
every 1 hour during first 4 hours after transferring to the ward
Method of measurement
VAS
Intervention groups
1
Description
injecting 20cc bupivacaine in to diaphragm cavity in intervention group