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To investigate the post – operative analgesic effect of intra – articular magnesium sulfate and Bupivacaine compared with Tramadol and Bupivacaine after knee arthroscopic surgeries.

Protocol summary

Summary
Objective: To compare the post – operative analgesic effect of intra – articular magnesium sulfate and Bupivacaine with Tramadol and Bupivacaine after knee arthroscopic surgeries. Study design: A single blind randomized clinical trial. Inclusion criteria: Aged over 19 and under 65 years old; (ASA I-II). Exclusion criteria: Biopsy or simple knee washing; chronic use of opium or tramadol. Methods: 43 patients undergoing arthroscopic knee surgery divided into two groups of 21 patients of each . The first intervention group (T): patients received 100 mg tramadol (50 mg / ml ampule, Tehran Chemie Pharmaceutical, Tehran, Iran) with 50 mg bupivacaine 0.25% (Bupivacaine-Milan 0.5%, Willy 20 Ml, Mylan, France) so that the final volume of solution is adjusted to 20 ml with normal saline and injected into the joint at the end of the surgery. The second intervention group (M): patients received 2 g magnesium sulfate (magnesium sulfate 50%, 50 ml vial., Pasteur Institute of Iran, Tehran, Iran) with 0.5 mg bupivacaine (0.25%) as the final volume with saline solution will be 20 ml and injected at the end of the joint operation. The pain scores (VAS) assessed before surgical procedure, in the recovery room and 24 hours after surgery.] The morphine IV, PCA pumps and total morphine consumption, any side effects, and the percentage of satisfaction with the quality of analgesia were compared between the groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016082719470N42
Registration date: 2017-10-01, 1396/07/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-01, 1396/07/09
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research,Shiraz University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To investigate the post – operative analgesic effect of intra – articular magnesium sulfate and Bupivacaine compared with Tramadol and Bupivacaine after knee arthroscopic surgeries.
Public title
To investigate the post – operative analgesic effect of intra – articular magnesium sulfate / Bupivacaine compared with Tramadol / Bupivacaine after knee arthroscopic surgeries.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Aged over 19 and under 65 years old; (ASA I-II). Exclusion criteria: Biopsy or simple knee washing; chronic use of opium or tramadol.
Age
From 19 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 43
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random Number Table is method for randomization.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2017-04-21, 1396/02/01
Ethics committee reference number
IR.SUMS.MED.REC.1395.28

Health conditions studied

1

Description of health condition studied
arthrosis of knee
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]

Primary outcomes

1

Description
Pain score
Timepoint
before surgical procedure, in the recovery and 24 hours after surgery
Method of measurement
VAS(visual analog scale)

2

Description
The morphine IV, PCA pumps and total morphine consumption
Timepoint
24 hours after surgery at 2, 4, 6, 8, 12, 16, 20, and 24
Method of measurement
Observasion

3

Description
any side effects of analgesics
Timepoint
24 hours after surgery at 2, 4, 6, 8, 12, 16, 20, and 24
Method of measurement
Observasion

Secondary outcomes

1

Description
patients stisfaction
Timepoint
After surgery in the ward
Method of measurement
Questionnaire

Intervention groups

1

Description
The first intervention group (T): patients received 100 mg tramadol (50 mg / ml ampoule, Tehran Chemie Pharmaceutical, Tehran, Iran) with 50 mg bupivacaine 0.25% (Bupivacaine-Milan 0.5%, Willy 20 Ml, Mylan, France) so that the final volume of solution is adjusted to 20 ml with normal saline and injected into the joint at the end of the surgery.
Category
Treatment - Drugs

2

Description
The second intervention group (M): patients received 2 g magnesium sulfate (magnesium sulfate 50%, 50 ml vial., Pasteur Institute of Iran, Tehran, Iran) with 0.5 mg bupivacaine (0.25%) as the final volume with saline solution will be 20 ml and injected at the end of the joint operation.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Afshin Zarei
Street address
Chamran Hospital, Chamran Boulevard
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Afshin Zarei
Position
anesthesiology resident/physician
Other areas of specialty/work
Street address
Anesthesiology Department- Faghihi Hospital- Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Sina Gafari
Position
Anesthesiologist, Transplant fellowship
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
sighafari@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in english teaching ,BS in anesthesia/English Consultant
Other areas of specialty/work
Street address
5th floor, Mohammad Rasul Allah Research Tower, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address

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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