Objective: Evaluating the effect of adding Dexamethasone/TNG to Lidocaine on the quality of Intravenous Regional Anesthesia (IVRA).
Study design: In a single central, prospective trial, 90 patients will randomly be allocated into 3 groups. Each group will comprise of 30 cases. The control group, L, will only receive Lidocaine. The intervention group of LD will receive Lidocaine plus Dexamethasone; and the intervention group of LN will receive Lidocaine plus TNG.The study will be blinded from researchers' and patients' side (double blind study).
Main inclusion criteria: Male or female patients; scheduled for hand or forearm surgery with I & II physical status of ASA; aged between 20 and 50 years.
Main exclusion criteria: Patients with sickle cell anemia; Raynaud's disease; history of drug allergy.
Setting and conduct: Following the basic preparation for intravenous regional anesthesia IVRA, group L will receive 3 mg/kg up to maximum 200 mg of Lidocaine, group LD besides to Lidocaine (similar to group L) will receive 8 mg of Dexamethosone, and group NL besides to Lidocaine (similar to group L) will receive 200 µg of Nitroglycerin.
Outcomes: As primary outcomes, the onset and the recovery times from sensory and motor blocks, and the starting time of tourniquet pain will be measured. As secondary outcomes, the amount of the required narcotics during patients’ recovery and probable side effects will be measured. The results will be compared between the three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015053122511N1
Registration date:2015-10-04, 1394/07/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-04, 1394/07/12
Registrant information
Name
Ebrahim Hassani
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
h_pirnejad@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2014-01-01, 1392/10/11
Expected recruitment end date
2014-10-16, 1393/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of adding Dexamethasone / TNG to Lidocaine on the quality of Intra-Venous Regional Anesthesia (IVRA)
Public title
Evaluating the quality of Intra-Venous Regional Anesthesia (IVRA) following adding Dexamethasone or TNG to Lidocaine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: male or female patients; scheduled for hand or forearm surgery with I & II physical status of ASA; aged between 20 and 50 years.
Exclusion criteria: Patients with sickle cell anemia; Raynaud's disease; history of drug allergy.
Age
From 20 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients will randomly be allocated to one of the three groups of Lidocaine (L), Lidocaine + Dexamethasone (LD), Lidocaine + TNG (LN); each group will be comprising of 30 cases.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethical Committee of Urmia university of medical sciences