In this double-blind randomized clinical trial study, we try to show the efficacy of Intraperitoneal dexamethasone on reliving shoulder pain after gynecologic laparoscopy. Our study population will be 18-70 years old women who has been referred to Arash Hospital with an gynechology indication for laparoscopy. Patients with diabetes, previous abdominal surgery and reaction to dexamethasone will be excluded. We randomly divide 63 patients into two groups: first group including 31 patients as dexamethasone group and second group including 32 patients as control (placebo) group. First group receive 16 mg dexamethasone intraperitoneally at the end of procedure whereas control group will receive 16 mg normal saline as placebo intraperitoneally, at the end of procedure. Visual analogue scale (VAS) will be used for clinical evaluation of pain severity during 24 hours after laparoscopy . A physician, who is not aware from treatment or placebo will evaluate the patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105306640N1
Registration date:2011-09-01, 1390/06/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-01, 1390/06/10
Registrant information
Name
Zahra Asgari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 8755
Email address
asgariza@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Arash Hospital
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2010-12-29, 1389/10/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intraperitoneal dexamethasone as a new method for reliving postoperative shoulder pain after gynecologic laparoscopy
Public title
Intraperitoneal dexamethasone as a new method for reliving postoperative shoulder pain after gynecologic laparoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female; 18 -70 years old; gynecologic indication for laparoscopy. Exclusion criteria: previous surgery on their abdomen; diabetes mellitus; drug reaction to dexamethasone; previous history of treatment with steroids.
Age
From 18 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
63
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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Science, Enghelab square
City
Tehran
Postal code
Approval date
2011-07-23, 1390/05/01
Ethics committee reference number
90/d/130/593
Health conditions studied
1
Description of health condition studied
shoulder pain after gynecologic laparoscopy
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
pain
Timepoint
4,8,12,24 hours after procedure
Method of measurement
Visual Analog Scale (VAS) scale
Secondary outcomes
empty
Intervention groups
1
Description
intervention: we will inject 16 cc dexamethasone intraperitoneally in case group at the end of laparascopy.
Category
Treatment - Drugs
2
Description
control: control group will received 16 mg normal saline as placebo intraperitoneally, at the end of procedure
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Arash hospital
Full name of responsible person
Dr Asgari
Street address
Rashid street, Resalat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences, Arash hospital
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Zahra Asgari
Position
assistant proffesor
Other areas of specialty/work
Street address
Arash Hospital, Rashid street ,Resalat highway
City
Tehran
Postal code
Phone
+98 21 7788 8755
Fax
+98 21 7788 8751
Email
asgariza@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Asgari
Position
assistant proffesor
Other areas of specialty/work
Street address
Arash Hospital , Rashid street , Resalat highway
City
Tehran
Postal code
Phone
+98 21 7788 8755
Fax
+98 21 7788 8751
Email
asgariza@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr sima mozafar Jalali
Position
resident
Other areas of specialty/work
Street address
Rashid street, Resalat highway
City
Tehran
Postal code
Phone
+98 21 7788 8755
Fax
+98 21 7788 8751
Email
simamjalali@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)