Comparison the effect of intra-articular injection of Bupivacaine and Morphine versus Bupivacaine and Methyl prednisolone on postoperative pain after knee surgery
Objectives: The purpose of this study is to compare the effect of intra-articular injection of Bupivacaine and Morphine versus Bupivacaine and Methyl prednisolone on postoperative pain in patients who are candidate for repairing anterior cruciate ligament through an arthroscopic knee surgery. Design: Study carry out in a single blind manner, one centric clinical trial and by simple randomized method (Sealed Envelope and the selection of colorful cards) on 105 patients with 20 to 80 year’s old, candidate for arthroscopic knee surgery in Rajaii hospital of Qazvin. Setting and conduct: Patients are randomly dividing into three groups (n= 35). In all patients Induction of anesthesia and route of surgery are the same Intervention: patients receive intra-articular injection of 8 ml bupivacaine 0.5 % with 5 mg morphine in group 1, 8 ml bupivacaine 0.5 % with 40 mg methylprednisolone in group 2, 8 cc bupivacaine 0.5 % with 1 ml distilled water in group 3 At the end of the surgery . Main outcome measures: Pain is assessed through visual analog scale (VAS) at 1, 2, 6, 12, 18 and 24 hours after the surgery. In addition, the amount of opioid consumption, and side effects of used drugs will evaluated during 24 hours after surgery and compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016083125676N5
Registration date:2017-02-22, 1395/12/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-22, 1395/12/04
Registrant information
Name
Hamid Kayalha
Name of organization / entity
Qazvin University of Medical Sciences & Health Services
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 1007
Email address
hkayalha@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Qazvin University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
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
Comparison the effect of intra-articular injection of Bupivacaine and Morphine versus Bupivacaine and Methyl prednisolone on postoperative pain after knee surgery
Public title
Comparison the effect of intra-articular injection of Bupivacaine and Morphine versus Bupivacaine and Methyl prednisolone on postoperative pain after knee surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients 20–80 years old; with American Society of Anesthesiologists (ASA) physical status I or II; scheduled for arthroscopic knee surgery.
Exclusion criteria: Patient with neuropathic pain; neurologic deficit in respective organ; surgical history on respective knee; any allergy to used drug; BMI>40; Presence of underlying diseases (cardiac, renal, arthritis & diabetes); chronic pain; coagulopathy; opium addiction.
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization method (Sealed envelope and the selection of colorful cards)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Medical Sciences
Street address
Shahid Bahonar Blvd, Qazvin.
City
Qazvin
Postal code
3419759811
Approval date
2016-10-29, 1395/08/08
Ethics committee reference number
IR.QUMS.REC.1395.120
Health conditions studied
1
Description of health condition studied
pain in knee
ICD-10 code
M79.6
ICD-10 code description
Pain in limb
Primary outcomes
1
Description
postoperative pain
Timepoint
1, 2, 6, 12, 18 and 24 hours after surgery
Method of measurement
Score of pain in Visual analog scale (VAS)
2
Description
Opioid consumption
Timepoint
During 24 hours after operation
Method of measurement
Mg of Pethidine
Secondary outcomes
1
Description
Drug side effects
Timepoint
During 24 hrs after the surgery
Method of measurement
Asking the patient
Intervention groups
1
Description
At the end of the surgery in group 1:intra-articular injection of 8 ml bupivacaine 0.5 % with 5 mg morphine will be done
Category
Prevention
2
Description
At the end of the surgery in group 2: intra-articular injection of 8ml bupivacaine 0.5 % with 40 mg methylprednisolone will be done
Category
Prevention
3
Description
At the end of the surgery in group 3: intra-articular injection of 8 ml bupivacaine 0.5 % with 1 ml distilled water will be done
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaee Hospital
Full name of responsible person
Dr Hamid Kayalha
Street address
Rajaee Hospital, Padegan Avenu, Qzvin.
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Qazvin University of Medical Sciences
Full name of responsible person
Dr. Taghi Naserpour
Street address
Shahid Bahonar Blvd, Qazvin
City
Qazvin
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 of Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hoda Shehamat
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Rajee Hospital, Padegan Avenu, Qzvin
City
Qazvin
Postal code
Phone
00
Fax
Email
hoda_shahamat@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Dr. Hamid Kayalha
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Rajaee Hospital ; Padegan Avenu ; Qzvin
City
Qazvin
Postal code
Phone
00
Fax
Email
h_kayalha@yahoo.comvcrc92@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hoda Shahamat
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Rajaee Hospital ; Padegan Avenu ; Qzvin
City
Qazvin
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)