Effect of washout of the Cholecystectomy surgery site with Marcaine or pethidine solution on pain after laparoscopic cholecystectomy gallbladder surgery
In this double blind clinical trial study, the effect of washout of the surgery site with Marcaine or pethidine on pain after laparoscopic cholecystectomy surgery of gallbladder will be evaluated. This study will be performed on 99 patients with gallbladder on bed and candidate for Laparoscopic Cholecystectomy in Velayat Hospital of Qazvin. In this study, patients are in ASA class I and II. Informed consent will be completed by patients, and who with sensitivity and allergy to Marcaine or petheidine or surgical complications are excluded. Patients were randomly divided into 3 groups on the basis of colored cards selection. After surgery, in the first group, the liver washout will be performed with 1.5% mg per kg of Marcaine diluted with 40 mL of saline normal; and in the second group will be performed with 0.5% mg per kg of pethedine diluted with 40 mL of saline; and in the third group will not make any infiltration. All three groups will be operated with the same surgical procedure. The postoperative pain will be assessed using a visual analog scale (VAS) at 1, 2, 4, 8, 16, 24 and 48 hours after surgery. For the VAS ≥ 4, patients treated with the usual narcotics such as 25 mg of pethidine by intravenous ampules. The required narcotic will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021632419N2
Registration date:2017-04-04, 1396/01/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-04, 1396/01/15
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
2016-08-22, 1395/06/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of washout of the Cholecystectomy surgery site with Marcaine or pethidine solution on pain after laparoscopic cholecystectomy gallbladder surgery
Public title
The effect of washout of the surgery site with Marcaine or petedine on postoperative analgesia in patients with gallbladder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: a tendency to cooperate in the study and signed an informed consent form; Laparoscopic cholecystectomy surgery.
Exclusion criteria: failure to discharge those with more than two days after Laparoscopic Cholecystectomy surgery; Marcaine or pethidine allergies; Class III and VI heart failure; Insufficiency of end Stage Renal Disease; Side effects of surgery; Open Cholecystectomy.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd., Qazvin
City
Qazvin
Postal code
Approval date
2017-02-14, 1395/11/26
Ethics committee reference number
IR.qums.rec.1395.281
Health conditions studied
1
Description of health condition studied
Gallstone
ICD-10 code
K82.0
ICD-10 code description
Occlusion of cystic duct or gallbladder without calculus
Primary outcomes
1
Description
Pain score after after the cholecystectomy surgery
Timepoint
After entering the recovery, during times of 1, 2, 4, 8, 16, 24 and 48 hours after surgery
Method of measurement
The patient will be trained on how to measure.The postoperative pain will be measured using the visual analogue scale (VAS).
Secondary outcomes
empty
Intervention groups
1
Description
In the first group, then prepare to surgery and immediately after cholecystectomy and before removing the trocar, the liver washout will be performed with 1.5% mg per kg of Marcaine diluted with 40 mL of saline solution.
Category
Treatment - Drugs
2
Description
In the second group, after the cholecystectomy, the liver washout will be performed with 0.5% mg per kg of pethedine diluted with 40 mL of saline normal.
Category
Treatment - Drugs
3
Description
In the third group will not make any infiltration.