Comparison of adding Magnesium Sulfate with low dose Dexamethasone on Ropivacaine solution in supraclavicular nerve plexus block for elective upper limb surgeries
Comparison of the onset of the sensory and motor block, the duration of the sensory and motor block, the duration of analgesia, as well as the total amount and dose of analgesic after the upper extremity surgery by supraclavicular nerve plexus block after adding Magnesium sulfate, Dexamethasone or Normal saline to Ropivacaine.
Design
Three arm parallel group randomised trial design of 64 patients
inclusion criteria:
1.Patients in the age group of 18 to 65 years old
2.Candidates for elective upper limb surgery with ASA class I, II
Non-inclusion criteria:
1.Multiple treuma
2.patients suffering from Diabietes mellitus, other neuropathies, coagulopathies, broncopumonary diseases, psychiatric diseases, opium addiction, chronic users of analgesia
3.Corticosteroid users at least in the recent year
4,Positive past allergic history to Magnesium sulfate
5.Loss of consciousness
Intervention groups
Group N(Ropivacaine5%+Normal saline 1cc)
Group D(Ropivacaine5%+1ccDexamethasone4mg)
Group S(Ropivacaine5%+1cc Magnesium sulfate20%)
Main outcome variables
The onset of the sensory and motor block
The duration of the sensory and motor block
The duration of analgesia after surgery
The total amount and dose of analgesics
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180325039148N3
Registration date:2019-06-06, 1398/03/16
Registration timing:prospective
Last update:2019-06-06, 1398/03/16
Update count:0
Registration date
2019-06-06, 1398/03/16
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
2019-06-22, 1398/04/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of adding Magnesium Sulfate with low dose Dexamethasone on Ropivacaine solution in supraclavicular nerve plexus block for elective upper limb surgeries
Public title
The effect of magnesium sulfate and dexamethasone on upper limb anesthesia
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
18-65 Years old
Candidates for elective upper limb surgery with ASA class I, II
Exclusion criteria:
Multiple trauma
Diabetes
Neuropathy
Loss of consciousness
Coagulopathy
Broncopumonary diseases
Psychiatric diseases
Opium addiction
Chronic using of analgesic
Corticosteroid using at least in the recent year
Positive past allergic history to Magnesium sulfate
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients in each group with roll of dice will be assigned to three treatment groups such that N 1 and 2 numbers (24cc rupivacaine 0.5% + 1cc normal saline), numbers 3 and 4 related to Group D (24cc rupivacaine 0.5% + 1cc dexamethasone 4 mg) and numbers 5 and 6 for group S (24cc rupivacaine 0.5% + 1 cc magnesium sulfate 20%).
Blinding (investigator's opinion)
Triple blinded
Blinding description
According to the same form of medications and preparing them by a technician, the reasercher won't know which drug has been used.
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
Gavazang Blvd.,Mousavi hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Approval date
2018-07-03, 1397/04/12
Ethics committee reference number
IR.ZUMS.REC.1397.068
Health conditions studied
1
Description of health condition studied
The effect of adding magnesium sulfate and dexamethasone to ropivacaine on the quality of supraclavicular nerve block in hand and wrist injury
ICD-10 code
S62
ICD-10 code description
Fracture at wrist and hand level
2
Description of health condition studied
The effect of adding magnesium sulfate and dexamethasone to ropivacaine on the quality of supraclavicular nerve block in forearm injury
ICD-10 code
S52
ICD-10 code description
Fracture of forearm
Primary outcomes
1
Description
Determination anesthesia and analgesia during surgery and postoperation period in hand surgeries
Timepoint
Beginnig of surgery_During of surgery_Recovery unit -up to 24 hours after surgey
Method of measurement
Visual Analogue Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 24cc Ropivacaine 0.5% + 1cc Normal Saline
Category
Treatment - Drugs
2
Description
Intervention group: 24cc Ropivacaine 0.5% + 1 cc Dexamethasone 4mg