The effect of adding magnesium to bupivacaine for femoral nerve block on postoperative pain in patients undergoing knee and femoral orthopedic operations
(1) Objectives: Determining efficacy of adding magnesium sulfate to bupivacaine with bupivacaine alone in femoral block for postoperative analgesia in femoral and knee operations.
(2) Design: Sixty patients who undergoe knee and femur surgery select and divide in two groups with 30 patients in a double blind study for random clinical test.(3) Setting and conduct: After informed consent block perform with sonnoguidance and nerve stimulator for confirming the nerve location and patients undergoe femur and knee surgery with spinal anesthesia divide in two groups with 30 membrs. In first group use 20cc bupivacaine 0.2%and in second group 19.6cc bupivacaine 0.2%with 0.4cc magnesium sulfate (200mg). The person who perform the block dosn,t know anything about drug nature. Aaccording to the qustionnare in all patients major variables included VAS /sedation RAMSY score /bromage score before and after block in times T1(before block)-T2(just after block)-3-6-12after that and the amount of additional analgesic evaluate. The quetionnare will complete with person who dosn,t know anything about the nature of drugs.
(4) Inclusion criteria: Patients' consent؛ No usage of anti- coagulant drugs؛ No infection at the site of injection؛ Age between 18 and 65 years old ؛ASA1&2
Exclusion criteria: Patient refusal( no consent of the patients) ؛Surgery on PCL؛ Any complication due to injection or drugs, Calcium channel blocker usage, History of advanced renal disease؛ Allergy to drugs and Central or peripheral neurologic disorders.(5) Intervention: Before block in all of the patients major variables such as VAS/RAMSY SCORE/BROMAGE SCORE and after block the listed variable with the amount of probable additional analgesic (20mg pethedin)and patient satisfication in times T1 before block-T2 after block-3-6-12 hours after that will control. Person who complete the questionnaire dosn,t know anythine about nature of injected drugs.
(6) Main outcome measures variables: Major variables are VAS and RAMSY sedation score and BROMAGE score and after the block this criteria with the amount of probable needed analgesic (20 mg pethedine IM)and patient satisfication evaluate. Statistical analysis perform with SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410137984N19
Registration date:2014-12-26, 1393/10/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-26, 1393/10/05
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
Vice chancellor for research, Iran university of medical sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding magnesium to bupivacaine for femoral nerve block on postoperative pain in patients undergoing knee and femoral orthopedic operations
Public title
The effect of adding magnesium to bupivacaine for femoral nerve block on postoperative pain in patients undergoing knee and femoral orthopedic operations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients' consent؛ No usage of anti- coagulant drugs؛ No infection at the site of injection؛ Age between 18 and 65 years old؛ ASA1&2
Exclusion criteria: Patient refusal( no consent of the patients)؛ Surgery on PCL؛ Any complication due to injection or drugs, Calcium channel blocker usage, History of advanced renal disease؛ Allergy to drugs and Central or peripheral neurologic disorders.
Age
From 18 years old to 65 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Iran university of medical sciences
Street address
Ethic committee ,Iran university of medical sciences, Hemmat Highway
City
Tehran
Postal code
Approval date
2014-08-24, 1393/06/02
Ethics committee reference number
93-02-30-24667-103610
Health conditions studied
1
Description of health condition studied
Postoperative Analgesia
ICD-10 code
R52
ICD-10 code description
Acute pain
2
Description of health condition studied
Postoperative Analgesia
ICD-10 code
T84.8
ICD-10 code description
Pain due to orthopedic internal implantation, fixation and other procedure
Primary outcomes
1
Description
pain score
Timepoint
before block-just after block-3-6-12 hours after block
Method of measurement
visual analog scale
Secondary outcomes
1
Description
Sedation
Timepoint
Just after block and 3-6-12 hours after block
Method of measurement
Sedation score
2
Description
Satisfication
Timepoint
Just after block and 3-6-12 houres after block
Method of measurement
Questionnare
3
Description
Additional requirement for opioid analgesics
Timepoint
Just after block and 3-6-12 hours after block
Method of measurement
Total dosage of injected additional analgesic in miligram
Intervention groups
1
Description
After the written informed consent from the patients in the study the femoral block perform with guide of sonography and nerve stimulator on the lateral side of femoral artery below the inguinal ligament for confirming the nerve location. In first group30 patient with femur or knee surgery by spinal anesthesia 19.6cc bupivacaine 0.2% with 0.4cc magnesium sulfate 50%(200 mg)perform injection. According to the questionnaire in all of patients the major variables such as VAS ,sedation score,bromage score before block and just after block and in times 3-6-12 after that the same criteria with the consumption of any other analgesic and patient satisfication will evaluate and record. For patients in this study questionnaire fille out by someone who does not know the nature of the injected drugs.
Category
Treatment - Drugs
2
Description
After the written informed consent from the patients in the study the femoral block perform with guide of sonography and nerve stimulator on the lateral side of femoral artery below the inguinal ligament for confirming the nerve location. In second group30 patient with femur or knee surgery by spinal anesthesia with 20cc bupivacaine 0.2% perform injection. According to the questionnaire in all of patients the major variables such as VAS ,sedation score,bromage score before block and just after block and in times 3-6-12 after that the same criteria with the consumption of any other analgesic and patient satisfication will evaluate and record. For patients in this study questionnaire fille out by someone who does not know the nature of the injected drugs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasoul-Akram Medical Centre
Full name of responsible person
Dr. Farnad Imani
Street address
Hazrat Rasoul-Akram Medical Centre,Nyayesh St.,Sattarkhan St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr. Ali Javad Mousavi
Street address
Vice chancellor for research, Iran University of Medical Sciences, Hemmat highway,Tehra,Iran
City
Tehran
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Farnad Imani
Position
Associate professor, Chief manager of anesthesiology department, Iran University of Medical Sciences
Other areas of specialty/work
Street address
Interventional pain operating room, 4th floor, Hazrat e Rasoul hospital, Nyayesh St., Satarkhan st., Tehran
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2107
Fax
+98 21 6650 9059
Email
farimani@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hazrat Rasoul akram hospital
Full name of responsible person
Dr. Farnad Imani
Position
Associate proffesor of anesthesiology,Fellow of interventional pain practise
Other areas of specialty/work
Street address
4th floor, Rasoul akram hospital, Nyayesh st., Satarkhan st., Tehran
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2107
Fax
+98 21 6650 9059
Email
farimani@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hazrat Rasoul akram hospital
Full name of responsible person
Dr. Farnad Imani
Position
Associate proffesor of anesthesiology,Fellow of interventional pain practise
Other areas of specialty/work
Street address
4th floor, Rasoul akram hospital, Nyayesh st., Satarkhan st., Tehran
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2107
Fax
+98 21 6650 9059
Email
farimani@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)