Aim: The aim of this study was to improve the quality of pain management and reduce the total fentanyl consumable in patients undergoing lower limb orthopedic surgery is spinal anesthesia. Study design: Study population, patients undergoing orthopedic surgery of the lower limbs, 102 patients in three groups of 34 patients and the control group (receiving saline intravenously cc10 slow), the first case group (receiving dexamethasone 8mg in PCA pump) and the second case group (receiving dexamethasone 16mg in PCA pump). Double-blind study and randomly divided the patients. In the study to all patients will be connected in the recovery room, intravenous pain pumps (PCA) containing 1 mg fentanyl in 100 cc saline bolus injection of 10 micrograms per cc and locking time will be 10 minutes and saline in the control group and dexamethasone in the case group Injected in the pump. Then of patients asked pain, nausea, vomiting and the need for pethidine to 24 hours and enter the pre-designed questionnaire. An inclusion criterion for this study is lower limb orthopedic surgery. This intervention study dexamethasone injection into the PCA pump in case group and normal saline in the control group. The primary outcome of pain, and secondary outcomes nausea, vomiting, pethidine requirement rate, blood pressure and heart rate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071928996N1
Registration date:2016-10-23, 1395/08/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-23, 1395/08/02
Registrant information
Name
Farzad Nabipour Asri
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 2520
Email address
f.nabipour@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ardabil University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of adding different doses of dexamethason to fentanil in patient control analgesia after lower limb orthopedic surgeries
Public title
The effects of different doses of dexamethasone on pain management in orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criterias:
patients with age 18 to 60 years old; patients under the lower limb orthopedic surgeries; patients with ASA class 1 or 2; patient"s satisfaction
exclusion criterias:allergy to dexamethasone or other corticostroides; addiction to opioeds or alchol and any drug abuse; affiction to peptic ulcer disease, renal or adrenal desease , osteopenia , osteoprosis; uncontroled HTN; ASA class > 2; pregnancy or breast feeding; corton therapy; NSAID therapy; Patients with platelet disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this randomized study was conducted as a random numbers table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Daneshgah St, Ardabil, IRAN
City
ARDABIL
Postal code
5618953141
Approval date
2016-06-13, 1395/03/24
Ethics committee reference number
IR.ARUMS.REC.1395.8
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
s82.1-s82.
ICD-10 code description
fracture of upper end of tibia , fracture of shaft of tibia , fracture of lower end of tibia
Primary outcomes
1
Description
pain
Timepoint
0 , 2 , 6 , 12 , 24 hrs after intervention
Method of measurement
VAS
Secondary outcomes
1
Description
analgesic consumption rate
Timepoint
0,2.6.12.24 hrs after intervention
Method of measurement
dosage rate
2
Description
nausea and vomiting
Timepoint
0,2,6,12,24 hrs after the intervention
Method of measurement
Postoperative nausea and vomiting score
3
Description
blood presure
Timepoint
0,2,6.12.24 hrs after the intervention
Method of measurement
manual mercuric pressure guage (mmHg)
4
Description
heart rate
Timepoint
0,2,6,12,24 hrs after the intervention
Method of measurement
Manual : bpm (Beats Per Minute)
Intervention groups
1
Description
The control group: received intravenous pain pump contains 1 mg of fentanyl with 10 mL of saline
Category
Treatment - Drugs
2
Description
The second group: received fentanyl-containing pain pumps plus 8 mg dexamethasone.
Both drugs are making in Aburaihan pharmaceutical company.
Category
Treatment - Drugs
3
Description
The second group received fentanyl-containing pain pumps plus 16 mg dexamethasone.
Both drugs are making in Aburaihan pharmaceutical company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Fatemi Hospital
Full name of responsible person
Farzad Nabipour Asri MD.
Street address
Shariati Sq
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Ardabil University of Medical Sciences
Full name of responsible person
Ghodrat akhavan akbari MD.
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
Vice chancellor for research 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
Farzad Nabipour Asri
Position
Physician / assistant anesthesia
Other areas of specialty/work
Street address
Daneshgah St, Ardabil University of Medical Sciences
City
Ardabil
Postal code
5618953141
Phone
+98 45 3351 2000
Fax
+98 45 3351 8939
Email
f.nabipour@arums.ac.ir
Web page address
www.arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dr Fatemi Hospital
Full name of responsible person
Ghodrat Akhavan Akbari
Position
Physician / Anesthesiologist
Other areas of specialty/work
Street address
Shariati Sq, Dr Fatemi Hospital
City
Ardabil
Postal code
56147
Phone
+98 45 3323 2520
Fax
+98 45 3323 2670
Email
f.nabipour@arums.asc.irfnabipourasri@gmail.com
Web page address
www.arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Dr. Fatemi Hospital
Full name of responsible person
Tayebe Salmanfar
Position
Physician / Anesthesiology residents
Other areas of specialty/work
Street address
Shariati Sq, Dr. Fatemi Hospital
City
Ardabil
Postal code
56147
Phone
+98 45 3323 2520
Fax
+98 45 3323 2670
Email
f.nabipour@arums.ac.ir
Web page address
www.arums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)