Comparison of the Effect of Oral Oxycodone and Saphenous Nerve Block in Controlling the Acute Post-operative Pain in Patients Undergoing Knee Replacement Surgery
Comparison of the Effect of Oral Oxycodone and Saphenous Nerve Block in Controlling the Acute Post-operative Pain in Patients Undergoing Knee Replacement Surgery
Design
Prospective
Settings and conduct
In the first group, two hours before surgery and every six hours after the operation on the patient's request and the presence of pain, an oxycodone tablet is orally administered at a dose of 5 mg . In the other group an ultrasound guided saphenous nerve block with 16 cc of 0.5% bupivacaine, plus epinephrine with a concentration of 1/200000 is done.
Study Place: Baqiyatolah Azam Hospital ,Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Aged 15-75 years
2- Candidates for knee replacement
3-Classification of American Society of Anesthesiology (ASA) I, II ( Healthy or underlying controlled illness)
Exclusion criteria:
1- Previous knee joint surgery
2- Bilateral surgery
3- Kidney or liver function disorders
4- History of allergic sensitization to Non-Steroidal Anti-Inflammatory Drugs
5- History of addiction
6- History of chronic drug use for pain control
7- History of cardiovascular or severe respiratory disease
8- History of neurological disease with lower limb involvement
9- History of gastrointestinal ulcer
10- Failure of block
Intervention groups
In one group, oral oxycodone was used and in the other group, the ultrasound guided saphenous nerve block was used to control post-operative pain
Main outcome variables
The amount of postoperative pain based on VAS (Visual Analog Scale) score and the complications of each methods, such as nausea, vomiting and hypotension at 2,6,12,24 hours after surgery are examined.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170826035905N3
Registration date:2018-11-21, 1397/08/30
Registration timing:retrospective
Last update:2018-11-21, 1397/08/30
Update count:0
Registration date
2018-11-21, 1397/08/30
Registrant information
Name
Nader Ali Nazemian Yazdi
Name of organization / entity
Tehran University of Medical Sciences/Amir Alam Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8830 3621
Email address
nnazemian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
2016-05-30, 1395/03/10
Actual recruitment end date
2017-05-31, 1396/03/10
Trial completion date
2017-06-01, 1396/03/11
Scientific title
Comparison of the Effect of Oral Oxycodone and Saphenous Nerve Block in Controlling the Acute Post-operative Pain in Patients Undergoing Knee Replacement Surgery
Public title
Evaluation of the effect of oral Oxycodone and Saphenous nerve block in knee replacement surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 15 and 75 years
Candidates for knee replacement surgery
Classification for American Society of Anesthesiology (ASA) I, II (patients with normal or mild and controlled underlying disease).
Exclusion criteria:
Previous knee joint surgery
Bilateral surgery
Kidney or liver function disorders,
History of allergic sensitization to non-steroidal anti-inflammatory drugs
History of addiction
History of chronic drug use for pain control
History of severe cardiovascular or respiratory disease
History of neurological disease with lower limb involvement
History of gastrointestinal ulcer
Failure of block
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Based on random numbers chart
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluator is blind about the study groups and the investigator is unaware of the consequences of the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Biomedical Researches of the Baqiyatallah University of Medical Sciences
Street address
Mollasadra Ave., Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
435793666 1
Approval date
2016-03-14, 1394/12/24
Ethics committee reference number
ir.bmsu.rec.1394.248
Health conditions studied
1
Description of health condition studied
Regional Anesthesia and Pain Management
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Pain
Timepoint
2,6,12,24 hours after surgery
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Nausea
Timepoint
2,6,12,24 hours after surgery
Method of measurement
Rating variable :Mild(0-1) Moderate(2-3) Severe(more than 3)
2
Description
Sedation
Timepoint
2,6,12,24 hours after surgery
Method of measurement
Rating variable :Mild(0-1) Moderate(2-3) Severe(more than 3)
Intervention groups
1
Description
In the first group, oral oxycodone was administered at a dose of 5 mg two hours before surgery and every six hours after operation based on patient request and presence of pain
Category
Treatment - Drugs
2
Description
In the second group the saphenous nerve block is performed in the adductor canal under ultrasound guide with 16 cc bupivacaine 0.5% and epinephrine with concentration of 1: 200,000 .
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatolah Azam Hospital
Full name of responsible person
Nader Ali Nazemian Yazdi
Street address
Mollasadra Blvd.
City
Tehran
Province
Tehran
Postal code
1435793666
Phone
+98 21 8805 3766
Email
drnnazemian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences/Trauma Research Center
Full name of responsible person
Nader Ali Nazemian Yazdi
Street address
Mollasadra Blvd.
City
Tehran
Province
Tehran
Postal code
1435793666
Phone
+98 21 8805 3766
Email
drnnazemian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah University of Medical Sciences/Trauma Research Center
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nader Ali Nazemian Yazdi
Position
Assistant Professor of Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
AmirAlam Hospital, North Saadi Street, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6676 0269
Fax
Email
drnnazemian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences/Amir Alam Hospital
Full name of responsible person
Nader Ali Nazemian Yazdi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pain Management
Street address
Amir Alam Hospital, Sa'di Street., Enghelab Ave.,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1589857541
Phone
+98 21 8830 3621
Fax
+98 21 6670 4805
Email
Drnnazemian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences/Amir Alam Hospital
Full name of responsible person
Nader Ali Nazemian Yazdi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pain Management
Street address
Amir Alam Hospital, Sa'di Street., Enghelab Ave.,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1589857541
Phone
+98 21 8830 3621
Fax
+98 21 6670 4805
Email
Drnnazemian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available