This double blind randomized clinical trial was performed on 60 patients with ASA I or II who were candidate for laparoscopic cholecystectomy in Velayat hospital in Qazvin of Iran. The age of patients ranged 20 to 70 years. Patients with history of diabetes, former bile ducts surgeries, sensitivity to local anesthesia drugs and addiction were excluded from the study. Patients were divided into case group (n: 30) and control group (n: 30) using randomized block design. Both groups received the same anesthesia method. In case groups; at the end of surgery before closing the surgical incision; 10 cc Bupivacaine 0.25% into two trocar sites( In each place 5 cc) were infiltrated. In control group; 10 cc normal saline into two trocar sites (In each place 5 cc) were infiltrated. Postoperative pain was recorded with the use of a visual analog scale at 1, 2, 4, 12 and 24 hours intervals after the surgery. Analgesia requirements and incidence of nausea and vomiting were also recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020632419N1
Registration date:2017-03-13, 1395/12/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-13, 1395/12/23
Registrant information
Name
Zahra Farahaninik
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3376 0620
Email address
z.farahaninik@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Qazvin University of Medical Sciences
Expected recruitment start date
2017-01-21, 1395/11/02
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating of effect of infiltration of bupivacaine local anesthetic to port site in post-operative pain relief in laparoscopic cholecystectomy
Public title
Evaluating of effect of infiltration of bupivacaine local anesthetic in post-operative pain relief in patients undergoing Laparoscopic Gallbladder Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients 20 to 70 years old; the category of America Society of Anesthesiology (ASA) are class 1 and 2; undergoing elective surgery laparoscopic cholecystectomy; consent to participate up to the end study.
Exclusion criteria: patients with history of Diabetes; former bile ducts surgeries; sensitivity to local anesthesia drugs; addiction.
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients will be set in using randomized block design two groups (30 persons in case group and also 30 persons in control group).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Qazvin University of Medical Sciences
Street address
Qazvin, Shahid Bahonar Blvd
City
Qazvin
Postal code
Approval date
2017-01-20, 1395/11/01
Ethics committee reference number
IR.QUMS.REC.1395.278
Health conditions studied
1
Description of health condition studied
Postoperative pain
ICD-10 code
T88.9
ICD-10 code description
Complication of surgical and medical care, unspecified
Primary outcomes
1
Description
post operative pain
Timepoint
At 1, 2, 4, 12 and 24 hours after surgery
Method of measurement
According to VAS pain score systems
2
Description
nausea and vomiting
Timepoint
Every 1 hour during first 4 hours after transferring to the ward
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In case groups; at the end of surgery before closing the surgical incision; 10 cc Bupivacaine 0.25% into two trocar sites( In each place 5 cc) were infiltrated.
Category
Prevention
2
Description
In control group; at the end of surgery before closing the surgical incision; 10 cc normal saline into two trocar sites (In each place 5 cc) were infiltrated.