The Effect of Adding Magnesium Sulfate to Ropivacaine in Femoral Nerve Block before Spinal Anesthesia on Pain Management in Femoral Fracture Surgeries: A Randomized Clinical Trial
Effect of adding magnesium sulfate to ropivacaine on femoral nerve block before spinal anesthesia on pain management in femoral fracture surgeries
Design
Two arms parallel-group randomized clinical trial with a triple-blinded of 104 patients. Random allocation of samples is done by block method using Proc PLAN SAS.
Settings and conduct
This three-blind clinical trial study will be performed on 104 patients undergoing femoral fracture surgery (in two intervention and control groups) at Ayatollah Mousavi Hospital in Zanjan. Random allocation of samples is done by block method using Proc PLAN SAS. Visual analog scale and demographic information questionnaire will be used to measure postoperative pain. Questionnaires are completed by the researcher during the operation and at hours (immediately after the operation, 6, 12, and 24 hours after the operation).
Participants/Inclusion and exclusion criteria
-Inclusion criteria: American Society of Anesthesiologists (ASA) Class I & II; Patients candidates for femoral fracture surgery
-Non-inclusion criteria: coagulation disorder; History of drug allergy; History of peripheral neuropathy; Existence of simultaneous fracture; History of mental disorder (based on medical record); Drug addiction
Intervention groups
Intervention group: Ultrasound-guided femoral nerve block (eZono AG/D-07743 Jena, Germany) will be performed before spinal anesthesia as 15 ml of ropivacaine 0.2% (made by MOLTEN)+0.5 ml of magnesium sulfate 50% (made by Shahid Ghazi Tabriz).
Control group: Ultrasound-guided femoral nerve block (eZono AG/D-07743 Jena, Germany) will be performed before spinal anesthesia as 15 ml of ropivacaine 0.2% (made by MOLTEN)+0.5 ml of normal saline (made by Shahid Ghazi Tabriz).
Main outcome variables
Postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180325039148N5
Registration date:2021-10-19, 1400/07/27
Registration timing:prospective
Last update:2021-10-19, 1400/07/27
Update count:0
Registration date
2021-10-19, 1400/07/27
Registrant information
Name
Saeed Jalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 0001
Email address
jalilis45@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Adding Magnesium Sulfate to Ropivacaine in Femoral Nerve Block before Spinal Anesthesia on Pain Management in Femoral Fracture Surgeries: A Randomized Clinical Trial
Public title
The effect of magnesium sulfate on lower limb anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-75 years old
American Society of Anesthesiologists (ASA) Class I & II
Patients candidates for femoral fracture surgery
Exclusion criteria:
Coagulation disorder
History of drug allergy
History of peripheral neuropathy
Existence of simultaneous fractures
History of mental disorder (based on medical record)
Drug addiction
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be assigned to the two groups by blocking the classification method based on age and sex. The blocks will be selected randomly with size 4. Proc PLAN SAS will be used to prepare the blocks and is given to the researcher who is responsible for collecting samples, and based on the code assigned to each patient (A, B, C, D), individuals are divided into two groups without a researcher's interference.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients know that they are participating in a study aimed at investigating the effect of femoral nerve block with Ropivacaine + normal saline and femoral nerve block with Ropivacaine + magnesium sulfate on pain management in femoral fracture surgery, but are unaware that Ropivacaine + Normal saline or Ropivacaine + Magnesium sulfate is used in the block of the femoral nerve for them.
Medications are coded, and the anesthetist who injects the medication does not know what type of medication the patients are receiving.
The person measuring the response or pain intensity will be unaware of the nature of the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Vice-Chancellor for Research and Technology, 3th Floor, 2th Bldg., Zanjan University of Medical Sciences, Azadi Blvd. Zanjan, IRAN.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2021-10-13, 1400/07/21
Ethics committee reference number
IR.ZUMS.REC.1400.297
Health conditions studied
1
Description of health condition studied
femoral fracture
ICD-10 code
M80.05
ICD-10 code description
Age-related osteoporosis with current pathological fracture, femur
Primary outcomes
1
Description
Determination of postoperative analgesia in Femoral fracture surgeries
Timepoint
Immediately after surgery, 6, 12 and 24 hours after surgery
Method of measurement
Visual analog scale of pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ultrasound-guided femoral nerve block (eZono AG/D-07743 Jena, Germany) will be performed before spinal anesthesia as 15 ml of ropivacaine 0.2% (made by MOLTEN) + 0.5 ml of magnesium sulfate 50% (made by Shahid Ghazi Tabriz).
Category
Treatment - Drugs
2
Description
Control group: Ultrasound-guided femoral nerve block (eZono AG/D-07743 Jena, Germany) will be performed before spinal anesthesia as 15 ml of ropivacaine 0.2% (made by MOLTEN) + 0.5 ml of normal saline (made by Shahid Ghazi Tabriz).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital, Zanjan
Full name of responsible person
Saeed Jalili
Street address
Ayatollah Mousavi Hospital, Gavazang Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
jalilis45@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Shoghli Alireza
Street address
Vice-Chancellor for Research and Technology, 3th Floor, 2th Bldg., Zanjan University of Medical Sciences, Azadi Blvd. Zanjan, IRAN.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6141
Email
shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
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
Zanjan University of Medical Sciences
Full name of responsible person
Saeed Jalili
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ayatollah Mousavi Hospital, Gavazang Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0001
Email
jalilis45@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Saeed Jalili
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ayatollah Mousavi Hospital, Gavazang Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0001
Email
jalilis45@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Saeed Jalili
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ayatollah Mousavi Hospital, Gavazang Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0001
Email
jalilis45@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD