Comparison effect of the intraperitoneal injection o f Marcaine with intravenous Ketorolac in postoperative pain control after Laparoscopic Cholecystectomy
The main objective of this study is to comparsion effect of the intraperitoneal injection of Marcaine with Intravenous Ketorolac on postoperative pain control after laparoscopic cholecystectomy surgery.
Methods: A double blind randomized clinical trial was conducted in the Imam hospital for elective laparoscopic cholecystectomy .
In this study the patients and researchers are blinded .ِِِDrugs put in three envelope for 1,2,3 and will receive for one patient. So that patient and researcher were blinded and partners of the project will injected.
The inclusion criteria: Patients are with average 20-60 years old that needs elective laparoscopic cholecystectomy surgery.
The exclusion criteria: Addicted patients, gastrointestinal diseases, susceptible diseases, sensitivity to anesthetic drugs and analgesics drugs postoperative pain.
At first ,Intravenous pain pump was applied to all three groups in recovery rooms. Pumps acts such as lock-out time for every 15 minutes, and (bolus) infusion pumps0.1ml at a concentration of 15mg / ml. The density of pumps was 30cc Fentanyl in 70 mg of normal saline and patient can use the pumps when pain.Then the patients classified randomly in to three groups.
Group A:the end of laparoscopic cholecystectomy injected 40 ml solution intraperitoneal Marcaine (0.25%). After intraperitoneal injection tilt the bed.
Group B: injected Intravenous Ketorolac (30 cc) once 30 minute before the end of
completion of the surgery and again re-injected Intravenous Ketorolac (30 cc) 8 and 16 hours after surgery
Group C: injected 40 ml of intraperitoneal normal saline with (plus) 2 ml of intravenous normal saline such as group 1and 2.
The visual analogue scale (VAS) has been used in this study for measurement pain of patient at 2,8,16,24 hours after surgery and compare consumption Fentanyl and nausea and vomting and scapula pain andabdominal pain .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606064131N2
Registration date:2016-09-21, 1395/06/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-21, 1395/06/31
Registrant information
Name
َAfshan Sharghi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 2012
Email address
a.sharghi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of the intraperitoneal injection o f Marcaine with intravenous Ketorolac in postoperative pain control after Laparoscopic Cholecystectomy
Public title
Comparison effect of the intraperitoneal injection o f Marcaine with intravenous Ketorolac in postoperative pain control
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria : Patients aged 20-60 years old ؛ elective laparoscopic cholecystectomy surgery.
The Exclusion criteria: Addicted patient ؛gastrointestinal diseases؛ susceptible diseases, sensitivity to anesthetic or analgesics drugs
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Research Ethics Committee of Ardabil University of Medical Sciences
Street address
Daneshgah st, Ardabil
City
Ardabil
Postal code
Approval date
2015-12-19, 1394/09/28
Ethics committee reference number
IR.ARUMS.REC.1394.70
Health conditions studied
1
Description of health condition studied
laparoscopic cholecystectomy
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
Primary outcomes
1
Description
Pain
Timepoint
2 & 8 &16 & 24 hours after surgery
Method of measurement
Visual Anlalog Scale (VAS )
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : Intravenous ketorolac (30 cc) once before completion of the surgery and again re-injected 8 and 16 hours after surgery
Category
Treatment - Drugs
2
Description
Control group : Intraperitoneal injection of 40 ml of normal saline with (plus) 2 ml of intravenous injection of normal saline
Category
Placebo
3
Description
Intervention group : intraperitoneal injection of Marcaine (0.25%) in 40 ml normal saline.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi Hospital Ardabil
Full name of responsible person
Dr Amir Ahmad Arabzadeh
Street address
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr ُSharhram Habibzadeh
Street address
Daneshgah St, Ardabil University of Medical Sciences
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Amir Ahmad Arabzadeh
Position
General Surgeon
Other areas of specialty/work
Street address
Fatemi Hospital ,Ardabil
City
Ardabil
Postal code
Phone
+98 45 3351 3777
Fax
Email
a.sharghi@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Afshan Sharghi
Position
Specilists of Community Medicine
Other areas of specialty/work
Street address
Medical School , Ardabil
City
Ardabil
Postal code
Phone
+98 45 3351 3777
Fax
Email
a.sharghi@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Afshan Sharghi
Position
Specialists Of Community Medicine
Other areas of specialty/work
Street address
Daneshgah St, Ardabil
City
Ardabil
Postal code
Phone
+98 45 3351 3777
Fax
Email
a.sharghi@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)