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Evaluation of effectiveness of parecetamol in reducing pain and morphine consumption in patients undergoing laparoscopic cholecystectomy surgery

Protocol summary

Summary
The aim of this study is evaluation of the effect of paracetamol on reducing pain after laparoscopic cholecystectomy surgery. Inclusion criteria : ASA class I ; Age between 18- 50 years.In this prospective double blind randomized study 30 patient were divided in intervention and control group . Exclusion Criteria : Operation less than one hour or more than three hours ; intraoperative bleeding more than 6 ml/kg ; liver or kidney disease ; addiction , alcoholism , ; patient reluctance to participate in the study . In intervention group 10 minutes after induction of anesthesia 1gr Paracetamol in 100ml of 0.9% NaCl was injected intravenously over 15 minutes . In the control group 10 minutes after induction of anesthesia 100 cc 0.9% NaCl was injected intravenously over 15 minutes. pain was recorded at extubation, 15 minutes , 30 minutes , one, two, three, four, five and six hours after extubation based on visual analog score. opioid consumption was recorded after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012111511473N1
Registration date: 2012-12-23, 1391/10/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-12-23, 1391/10/03
Registrant information
Name
Seyed Ali Sahafi
Name of organization / entity
School of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 0168
Email address
sahafi.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Science
Expected recruitment start date
2012-05-09, 1391/02/20
Expected recruitment end date
2012-11-10, 1391/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness of parecetamol in reducing pain and morphine consumption in patients undergoing laparoscopic cholecystectomy surgery
Public title
Analgesic effect of paracetamol after laparoscopic cholecystectomy surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria : ASA class I ; Age between 18- 50 years Exclusion Criteria : Operation less than one hour or more than three hours ; intraoperative bleeding more than 6 ml/kg ; liver or kidney disease ; addiction ; alcoholism ; patient reluctance to participate in the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Shahrak Daneshgah , Golestan
City
Ahvaz
Postal code
Approval date
2011-04-15, 1390/01/26
Ethics committee reference number
ETH-421

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
Acute Pain

Primary outcomes

1

Description
Postoperative Pain
Timepoint
0 minute, 15 minutes , 30 minutes, 1 , 2 , 3 , 4 , 5 and 6 hours after extubation
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Nausea and Vomiting
Timepoint
After six hours of extubation
Method of measurement
Frequency

Intervention groups

1

Description
In intervention group 10 minutes after induction of anesthesia 1gr Paracetamol in 100ml of 0.9% NaCl was injected intravenously over 15 minutes
Category
Prevention

2

Description
In the control group 10 minutes after induction of anesthesia 100 cc 0.9% NaCl was injected intravenously over 15 minutes.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr Seyed Ali Sahafi
Street address
Felestin Avenue
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Mostafa Feghhi
Street address
Shahrak Daneshgah , Golestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
School of Medicine , Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Sholeh Nesioonpour
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Azadegan Avenue , Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
Email
nesioonpour-sh@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Medicine , Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Seyed Mohamadreza Gousheh
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Azadegan Avenue , Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
Email
r.gousheh@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Medicine , Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Seyed Ali Sahafi
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Azadegan avenue , Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
+98 61 1222 0168
Email
ahafi.a@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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