The effect of using abdominal drainage after laparoscopic cholecystectomy in postoperative pain in patients with cholelithiasis
Design
Two arm parallel group randomized trial with 60 patients in two groups. Study group with subhepatic drainage after laparoscopic cholecystectomy and control group without drains.
Settings and conduct
The study is conducted in Taleghani hospital in tehran.
Participants/Inclusion and exclusion criteria
Sixty patients enrolled in the study according to inclusion and exclusion criteria, and after consent they undergo laparoscopic cholecystectomy. Inclusion criteria:Patients scheduled for elective laparoscopic cholecystectomy due to gallbladder stones.
Exclusin criteria: ASA Physical Status more than 3, renal insufficiency & history of coagulopathy.
Intervention groups
In the study group, sub-hepatic drainage is used. No drain is used in the control group.
Main outcome variables
Following the surgery, postoperative pain level was assessed using universal pain assessment tool (UPAT) at 0, 2, 4, 6, 12 and 24 hours after the operation. The postoperative morphine dose , the first analgesia consumption time and complications were noted.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130706013875N2
Registration date:2019-05-05, 1398/02/15
Registration timing:retrospective
Last update:2019-05-05, 1398/02/15
Update count:0
Registration date
2019-05-05, 1398/02/15
Registrant information
Name
Farhad Fathi
Name of organization / entity
Shahid Beheshti University of Medical Sciencces
Country
Iran (Islamic Republic of)
Phone
+98 21 4427 7264
Email address
ffathi@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2018-07-23, 1397/05/01
Actual recruitment end date
2018-09-23, 1397/07/01
Trial completion date
2018-10-23, 1397/08/01
Scientific title
Evaluation of using abdominal drainage after laparoscopic cholecystectomy in post operative pain
Public title
Effect of abdominal drainage vs no drainage in laparoscopic cholecystectomy on post op pain management
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patients who suffer from cholelithiasis
The patients undergoing elective laparoscopic cholecystectomy
Exclusion criteria:
ASA Physical Status more thean 3
Renal insufficiency
History of coagulopathy
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study through simple randomization method with the table of random numbers, patients assigned to two groups
A balanced block method is used to allocate concealment so that the number of samples assigned to each of the groups is equal.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Next to Ayatollah Taleghani Hospital ,Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2018-05-15, 1397/02/25
Ethics committee reference number
IR.SBMU.MSP.REC.1397.195
Health conditions studied
1
Description of health condition studied
Gallbladder stone
ICD-10 code
K80.2
ICD-10 code description
Calculus of gallbladder without cholecystitis
Primary outcomes
1
Description
post operative pain
Timepoint
Post op time: 0-2-4-6-12-24 hour
Method of measurement
Universal Pain Assessment Tool
2
Description
Total morphine sulfate dose in the 24 hours after surgery
Timepoint
24 hours
Method of measurement
milligrams
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, the standard laparoscopic cholecystectomy operation was done, then the subhepatic drainage was inserted. The patients were transfered to recovery room and ward afterwards.
Category
Prevention
2
Description
Control group: In this group, the standard laparoscopic cholecystectomy operation was done. The patients were transfered to recovery room and ward afterwards. No drainage was inserted.