The aim of this study is to comparison of suppository morphine with suppository diclofenac in the treatment of postoperative pain laparoscopic cholecystectomy. This study is an intervention and double-blind in patients who under laparoscopic cholecystectomy will be done.
After obtaining written informed consent from eligible patients and getting an approval from Ethics committee of Ahvaz Jundishapur University of Medical Sciences, 54 patients will be dividing in 2 groups under laparoscopic cholecystectomy.
Criteria for inclusion of study: ASA class I & II; years old 50-20.
Criteria for exclusion of study: History of hypnotics or narcotics throughout 24 hours before the surgery; Contraindication of morphine or diclofenac; Renal or hepatic
failure; Peptic ulcer disease or rheumatoid arthritis.
Group "one" and "two" will receive 100 mg suppository diclofenac and 10 mg suppository morphine after end of surgery, respectively.
Postoperative Pain and need for analgesic will measure at 1, 2, 3, 4, 6, and 8 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013022012540N1
Registration date:2013-11-27, 1392/09/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-11-27, 1392/09/06
Registrant information
Name
Fereshte Amiri
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 0168
Email address
amiri.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Expected recruitment start date
2014-01-05, 1392/10/15
Expected recruitment end date
2014-03-06, 1392/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of suppository Morphine with suppository Diclofenac on postoperative pain laparoscopic cholecystectomy
Public title
Comparison of suppository Morphine with suppository Diclofenac on postoperative pain laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Criteria for inclusion of study: ASA class I & II; years old 50-20.
Criteria for exclusion of study: History of hypnotics or narcotics throughout 24 hours before the surgery; Contraindication of morphine or diclofenac; Renal or hepatic
failure; Peptic ulcer disease or rheumatoid arthritis.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Ahvaz Jundishapur University of Medical Sciences
Street address
No.12, Chamber Sadaf, Golestan Blvd
City
Ahvaz
Postal code
6135733777
Approval date
2012-12-01, 1391/09/11
Ethics committee reference number
Eth-623
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
Pain
Timepoint
1, 2, 3, 4, 6 and 8 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Opioid Consumption
Timepoint
1, 2, 3, 4, 6 and 8 hours after surgery
Method of measurement
Milligrams
Intervention groups
1
Description
Diclofenac:
- Dose: 100 mg
- Number of using: Once
Factory name: Behvazan
Manufacturing Country's Name: Iran
Location prescribed: Suppository
Administration time: after end of surgery
Category
Treatment - Drugs
2
Description
Morphine:
- Dose: 10 mg
- Number of using: Once
Factory name: Abureihan
Manufacturing Country's Name: Iran
Location prescribed: Suppository
Administration time: after end of surgery