The purpose of this study was to investigate the effect of adding dexamethasone to bupivacaine on duration of spinal anesthesia in patients with lower limb surgery. This study is a double blind clinical trial on 50 patients undergoing lower extremity surgery. Patients divided into two groups. Spinal anesthesia induced with spinal needle number 25 at the L4-L5 space in a sitting position. Patients in group bupivacaine received 2 mL bupivacaine 0.5% by adding 1 mL of saline mixture and patients of group bupivacaine + dexamethasone received 2 mL bupivacaine plus 4 mg of dexamethasone .Sensory level of spinal anesthesia was recorded after every 30 seconds to 20 minutes. Then sensory level measured every 5 minutes until reduced to 4. (Onset) time was recorded.( onset: the time interval between spinal anesthesia to achieve the highest level of sensory anesthesia). VAS scores according to scoring system was measured and recorded. Patients at the time of discharge, before and one month after the hospital discharge were followed up. Information on height, weight, age and sex of the patients and complications include nausea and vomiting were also recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312182963N17
Registration date:2014-02-02, 1392/11/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-02, 1392/11/13
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi Medical University of Yazd
Expected recruitment start date
2012-05-01, 1391/02/12
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding dexamethasone to bupivacaine on the duration of spinal anesthesia in patients with lower limb surgery
Public title
The effect of adding dexamethasone to bupivacaine on the duration of spinal anesthesia in patients with lower limb surgery
Purpose
Treatment
Inclusion/Exclusion criteria
including Criteria: 50 patients aged 18 to 70 years with ASA1,2 undergoing for lower limb orthopedic surgery.
excluding Criteria: history of cardiovascular disease; diabetes; history of chronic pain; addiction; allergy to local anesthetics; long-term use of corticosteroids and sedatives; infection at the site of spinal anesthesia; history of neurological and psychological disorders; history of spinal surgery; history of chronic low back pain.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
shahid sadoughi medical university of yazd
Street address
bahonar square
City
yazd
Postal code
89177
Approval date
2012-05-28, 1391/03/08
Ethics committee reference number
32250/1/17/پ
Health conditions studied
1
Description of health condition studied
lower limb orthopedic surgery
ICD-10 code
T12
ICD-10 code description
Fracture of lower limb, level unspecified
Primary outcomes
1
Description
duration of spinal anesthesia
Timepoint
each 30 seconds to 20 minutes after spinal anesthesia
Method of measurement
by physical exam
Secondary outcomes
1
Description
pain in surgical site
Timepoint
after pain or reduction in sensory block in 4 dermatom