Comparison of the effect of adding midazolam, paracetamol, tramadol and magnesium sulphate to ropivacaine in reducing pain and hemodynamic changes in intravenous local anesthesia
Comparison of the effect of adding midazolam, paracetamol, tramadol and magnesium sulphate to ropivacaine in reducing pain and hemodynamic changes in intravenous local anesthesia
Design
The study will be double blind and clinical trial.160 patients will be randomly divided into 5 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Patients candidate for forearm surgery in valiasr Hospital in Arak are divided into 5 groups by simple randomization with envelopes. The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: no history of allergy to the drugs used in the study, no more than one fracture in the body or surgery, absence of neurological disorders in the hand
Exclusion criteria:For any reason, local intravenous anesthesia may be terminated during surgery, not consent to participate in study
Intervention groups
Intervention group 1: 50 milligram in kilogram of magnesium sulfate 50% made by Shahid Ghazi Pharmaceutical Company of Tabriz with rupivacaine two tenths of a percent will inject.
Intervention group 2: 200 milligram of paracetamol made by Tehran Shimi Company with Rupivacaine two tenths of a percentwill inject.
Intervention group 3: 100 mg of tramadol made by Caspian Tamin Rasht Company - Iran with Rupivacaine two tenths of a percent will inject.
Intervention group 4: 50 micro geram in kilogram midazolam made by Caspian Tamin Rasht - Iran with Rupivacaine two tenths of a percent will inject.
Control group: 5 ml of normal saline with 35 ml of rupivacaine two tenths of a percent with a total volume of 40 ml will be injected intravenously.
Main outcome variables
Duration of sensory and motor block, pain, average use opioids
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N168
Registration date:2021-11-05, 1400/08/14
Registration timing:prospective
Last update:2021-11-05, 1400/08/14
Update count:0
Registration date
2021-11-05, 1400/08/14
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of adding midazolam, paracetamol, tramadol and magnesium sulphate to ropivacaine in reducing pain and hemodynamic changes in intravenous local anesthesia
Public title
Comparison of the effect of adding midazolam, paracetamol, tramadol and magnesium sulphate to ropivacaine in reducing pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate of forearm surgery
ASA class 1 and 2
No Raynaud's disease
Absence of any vascular disease
No sickle cell anemia
No history of allergy to the drugs used in the study
Lack of cyanosis of the affected limb
Do not use drugs and psychotropic substances
No contraindication to intravenous anesthesia
No more than one fracture in the body or surgery
Absence of chronic pain syndrome
Absence of neurological disorders in the hand
Exclusion criteria:
For any reason, local intravenous anesthesia may be terminated during surgery
Not consent to participate in study
Duration of operation less than 30 minutes or more than 90 minutes
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 5 groups using a permuted balanced block randomization method with the size of blocks 3 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is a double-blind study. Analysts, evaluators, and participants are unaware of the grouping.The intern is unaware of the drugs prescribed in each group and the anesthesiologist prepares the drugs and provides them to the intern, and the patients are not aware of their group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2021-10-10, 1400/07/18
Ethics committee reference number
IR.ARAKMU.REC.1400.173
Health conditions studied
1
Description of health condition studied
Forarm surgery
ICD-10 code
S55.001S
ICD-10 code description
Unspecified injury of ulnar artery at forearm level, right arm, sequela
Primary outcomes
1
Description
Sensory block
Timepoint
From the beginning study to 24 hours
Method of measurement
Physical examination
2
Description
Motor block
Timepoint
From the beginning study to 24 hours
Method of measurement
Physical examination
3
Description
Pain
Timepoint
After filling the tourniquet, 15, 30 and 45 minutes after the start of surgery and 30, 60, 90 and 120 minutes after the end of surgery
Method of measurement
Visual analogue pain questionnaire
4
Description
Average use opioids
Timepoint
Within 24 hours after surgery
Method of measurement
View file
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 50 milligram in kilogram of magnesium sulfate 50% made by Shahid Ghazi Pharmaceutical Company of Tabriz with rupivacaine two tenths of a percent will inject.
Category
Treatment - Drugs
2
Description
Intervention group 2: 200 milligram of paracetamol made by Tehran Shimi Company with Rupivacaine two tenths of a percent will inject.
Category
Treatment - Drugs
3
Description
Intervention group 3: 100 mg of tramadol made by Caspian Tamin Rasht Company - Iran with Rupivacainetwo tenths of a percent will inject.
Category
Treatment - Drugs
4
Description
Intervention group 4: 50 micro geram in kilogram midazolam made by Caspian Tamin Rasht - Iran with Rupivacainetwo tenths of a percent will inject.
Category
Treatment - Drugs
5
Description
Control group: 5 ml of normal saline with 35 ml of rupivacaine two tenths of a percent with a total volume of 40 ml will be injected intravenously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
modir.he@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?