Protocol summary

Summary
After written informed consent, 120 ASA I and II patients scheduled for lower orthopedic surgery under epidural anesthesia were selected for this stuidy. Inclusion criteria: age between 18-65 years old; ASA I and II and scheduled for lower extremity orthopedic surgery. Exclusion criteria: Opioid adiction or abuse; lower extremity muscle weakness; hypersensitivity to opioids; patient refusal at any time during projetc and coagulopathy or anticoagulant therapy. Postoperative pain relief was performed by PCA (Patient Controlled Analgesia) as continous epidural analgesia and 5ml/h infusion rate. The patients were randomly allocated into two groups: 1- (R group) ropivacaine 0.3% plus fentanyl (2 mcg/ml) and 2- (B group) bupivacaine 0.2% plus fentanyl (2 mcg/ml). If the pain score (VAS) was more than 3, fentanyl 1mcg/kg iv was slowly administered. Pain assessed by Visual Analogue Score (0= no pain, 10= the worst imaginable pain) and Verbal Rating Scale (0= no pain, 1= mild, 2= moderate, and 4= sever pain). Motor blockade was assessed by Bromage scale (0= complete lower limb movement, 1= unable to hip flexion, 2= unable to knee flexion, and 3= unable to ankle flexion). Nausa and vomiting assessed as 1) no nausa and vomiting, 2) mild nausa without need to medication, 3) nausa need to medication, 4) unresponce to single dose of anti-emetic drug. Patient satisfaction evaluated by: 1) excellent, 2) good, 3) fair, and 4) dissatisfied. Also, presence or abscence of itching and urinary retention were recorded. All above data were recorded at immediate before pump filling, 6, 12, 24, 36 and 48 hours later. Collected data were analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202277984N4
Registration date: 2012-05-30, 1391/03/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-05-30, 1391/03/10
Registrant information
Name
Farnad Imani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 5758
Email address
farnadimani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medicl Sciences (TUMS)
Expected recruitment start date
2012-02-19, 1390/11/30
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of postoperative analgesia and side effects of ropivacine and bupivacaine by continous epidural analgesia after lower extremity orthopedic surgery
Public title
Comparison of postoperative analgesia and side effects of ropivacine and bupivacaine by continous epidural analgesia after lower extremity orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-65 years old; ASA I and II and scheduled for lower extremity orthopedic surgery. Exclusion criteria: Opioid adiction or abuse; lower extremity muscle weakness; hypersensitivity to opioids; patient refusal at any time during projetc and coagulopathy or anticoagulant therapy
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Tehran University of Medical Sciences (TUMS)
Street address
Poursina St, Tehran
City
Tehran
Postal code
1445613131
Approval date
2012-02-12, 1390/11/23
Ethics committee reference number
90-03-30-12927-46840

Health conditions studied

1

Description of health condition studied
Analgesia after lower extremity orthopedic sugery
ICD-10 code
M96.6
ICD-10 code description
Fracture of bone following insertion of orthopaedic implant, joint prosthesis, or bone plate

Primary outcomes

1

Description
Pain
Timepoint
data were recorded at immediate before pump filling, 6, 12, 24, 36, and 48 hours later
Method of measurement
Visual Analog Scale (VAS)

Secondary outcomes

1

Description
Motor blockade
Timepoint
data were recorded at immediate before pump filling, 6, 12, 24, 36, and 48 hours later
Method of measurement
Bromage scale

Intervention groups

1

Description
Ropivacaine in case group
Category
Treatment - Drugs

2

Description
Bupivacaine in control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Medical Center
Full name of responsible person
Farnad Imani
Street address
Department of Anesthesiology and Pain Medicine, Rasoul Akram Medical Center
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy, Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Dr Fotouhi
Street address
Tehran University of Medical Sciences (TUMS), Ghods St, Keshavarz Blv,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy, Tehran University of Medical Sciences (TUMS)
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 ciences
Full name of responsible person
Farnad Imani
Position
Chairman , Department of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology and Pain, Rasoul-Akram Medical enter, Niayesh St, Sattar-khan Av
City
Tehran
Postal code
144561311
Phone
+98 21 6650 9059
Fax
+98 66509059
Email
farimani@tums.ac.ireditor@anesthpain.com
Web page address
www.anesthpain.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Associate professor and Chairman/ Depatment of Anesthesiology
Other areas of specialty/work
Street address
Depatment of Anesthesiology and Pain Medicine/ Rasoul Akram Medical Center
City
Tehran
Postal code
1445613131
Phone
+98 21 6650 9059
Fax
+98 21 6650 9059
Email
farimani@tums.ac.ireditor@anesthpain.com
Web page address
www.anesthpain.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Chairman, Department of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology and Pain, Rasoul-Akram Medical Center, Niayesh St, Sattar-khan Av
City
Tehran
Postal code
1445613131
Phone
+98 21 6650 9059
Fax
+98 66509059
Email
farimani@tums.ac.ireditor@anesthpain.com
Web page address
www.anesthpain.com

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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