Comparison of interavenous patient controlled analgesia and epidural patient controlled analgesia methods after knee or hip arthroplasty operations in Ayatollah Kashani hospital -Isfahan
This study will be done in order to compare two methods of patient controlled analgesia after knee or hip arthroplasty on patients referred to Isfahan Kashani Hospital. Patients who sign the informed consent form of the research will be randomly assigned to two groups in the surgery room (considering the equal number of each type of surgery in two groups). The patients in group A (epidural patient controlled analgesia )and group B (venous patient controlled analgesia). In all patients, epidural anesthesia catheter will be connected to P.C.A pump remaining for 24 hours and venous catheter pump will be installed too. In group A, mixture of Fentanil and marcaiene solution will be prescribed by P.C.A pump as intervention and in group B morphine via venous P.C.A pump as a control method. The prescription of medicine and placebo continues up to 24 hours and patients will be under observation in I.C.U. In addition, 150 CC normal saline will be prescribed as placebo by venous pump in group A and by epidural pump in group B. An independent assessor will check the level of consciousness, blood pressure, heart rate, respiratory rate, level of pain, and side effects such as nausea and vomiting, pruritus, urinary retention and additional narcotic usage based on predetermined times. The results will be compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902023771N1
Registration date:2010-06-15, 1389/03/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-06-15, 1389/03/25
Registrant information
Name
Gholamreza Khalili
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1233 0066
Email address
khalili@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellory for Research & Technology, Isfahan University of Medical Sciences
Expected recruitment start date
2010-06-24, 1389/04/03
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of interavenous patient controlled analgesia and epidural patient controlled analgesia methods after knee or hip arthroplasty operations in Ayatollah Kashani hospital -Isfahan
Public title
Patient Controlled Analgesia for Total Hip or Knee Arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria of the study :patients that are in the range of 40-80 years ,have 1-3 ASA ,are candidates of hip or knee replacement surgery & sign the consent form. Non inclusion criteria:patients that have contraindication for regional anesthesia or coagulopathy ,platelet count less than 100000 or chronic renal failure (G.F.R<60),and narcotic addiction . Exclusion criteria : Incomplete regional anesthesia, change to spinal anesthesia.
Age
From 40 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional ethics committee of Isfahan University of Medical Sciences
Street address
Vice Chancellory for Research & Technology, Bldg.no 4, Isfahan University of Medical Sciences, HezarJerib street
City
Isfahan
Postal code
81745-319
Approval date
2010-04-05, 1389/01/16
Ethics committee reference number
188147
Health conditions studied
1
Description of health condition studied
post hip or knee arthroplasty surgery pain
ICD-10 code
Z45.1
ICD-10 code description
Adjustment and management of infusion pump
Primary outcomes
1
Description
postoperative pain
Timepoint
0, 6, 12, and 24 hours after operation
Method of measurement
Visual analogue Scale
2
Description
Level of Conciousness
Timepoint
0, 6, 12, and 24 hours after operation after recovery room enterance
Method of measurement
A 4 point likert scale
3
Description
pulse rate
Timepoint
0, 6, 12, and 24 hours after operation
Method of measurement
pulse oximeter
4
Description
blood pressure
Timepoint
0, 6, 12, and 24 hours after operation
Method of measurement
oscillometer
5
Description
hypoxia
Timepoint
postoperative within 24 hours of surgery
Method of measurement
pulse oximeter
Secondary outcomes
1
Description
urinary retention
Timepoint
postoperative within 24 hours of surgery
Method of measurement
using checklist
2
Description
pruritus
Timepoint
postoperative within 24 hours of surgery
Method of measurement
using checklist
3
Description
vomitting and Nausea
Timepoint
postoperative within 24 hours of surgery
Method of measurement
using checklist
Intervention groups
1
Description
Intervention group: Epidural PCA( Analgesic Solution (marcaine 0.0625 -0.125% -fentanil 5ug/ml), continuos Rate (ml/hr): 4-10-Demand Dose (ml): 3-4-Lokout Interval: 10-15min) for 24 hours)+ 150 cc normal saline via Intravenous PCA pump as placebo
Category
Treatment - Devices
2
Description
Control group: Intravenous PCA (Morphine 1mg/ml-Size of bolus: 0.5-2.5mg- Lockout Interval (min): 5-10min- Contionuos Infusion: 0.01-0.3mg/kg/hr) for 24 hours)+ 150 cc normal saline via Epidural PCA pump as placebo
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah kashani hospital
Full name of responsible person
Dr. Gholamreza Khalili
Street address
Ayatollah kashani hospital, Ayatollah kashani street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research & Technology, Isfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research & Technology
Street address
Vice Chancellory for Research & Technology, Bldg.No.4, Isfahan University of Medical Sciences, HezarJerib Street
City
Isfahan
Grant name
گرانت پژوهشی
Grant code / Reference number
188147
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research & Technology, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Mahtab AghaKarimi
Position
Nurse/Master of Science
Other areas of specialty/work
Street address
Ayatollah Kashani Hospital- Ayatollah kashani street
City
Isfahan
Postal code
Phone
+98 31123300917
Fax
+98 31 1233 5030
Email
mahtabaghakarimi@yahoo.com
Web page address
kashani.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Khalili
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ayatollah kashani Hospital-Ayatollah Kashani Street
City
Isfahan
Postal code
Phone
+98 31123300917
Fax
+98 31 1233 5030
Email
khalili@med.mui.ac.ir
Web page address
kashani.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Khalili
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ayatollah Kashani Hospital, Ayatllah Kashni street
City
Isfahan
Postal code
Phone
+98 31123300917
Fax
+98 31 1233 5050
Email
khalili@med.mui.ac.ir
Web page address
kashani.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)