This is a randomized clinical trial which was done on two groups of 70 patients, with physical status ASA I or II, undergoing anorectal surgical procedures in Imam Reza Hospital, Kermanshah. They received 2mg 0.5% Bupivacaine or 5mg 0.5% Bupivacaine. Necessary time for anesthesia, peak block height by drug, recovery duration, patients' ambulation in recovery unit and operation duration were evaluated by examining the patient and filling out the Mc-Gill questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901213562N1
Registration date:2010-04-10, 1389/01/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-10, 1389/01/21
Registrant information
Name
Khosro Farhadi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1428 2670
Email address
kh-farhadi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2009-08-15, 1388/05/24
Expected recruitment end date
2010-02-15, 1388/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of Bupivacaine different doses in spinal anesthesia in anal surgeries
Public title
Comparing different doses of Bupivacaine in spinal anesthesia in anal surgeries
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients who were candidate for elective anal surgeries with ASA I or II. Exclusion criteria: patients who had pain and did not answer to injecting 1cc of Fentanyl or the ones who their surgery took more than 15 min.
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah university of medical sciences
Street address
#2 building, Shahid beheshti boulevard
City
Kermanshah
Postal code
67144-15333
Approval date
2009-08-15, 1388/05/24
Ethics committee reference number
2762/420/7p
Health conditions studied
1
Description of health condition studied
spinal anesthesia
ICD-10 code
T80-T88
ICD-10 code description
complications of surgical and medical care, not elsewhere classified
Primary outcomes
1
Description
pain degree
Timepoint
after performing spinal anesthesia and during surgery
Method of measurement
Mc-Gill quesionnaire and VAS method
Secondary outcomes
1
Description
ability to walk and finishing the block of S4 dermatom
Timepoint
after finishing the surgery
Method of measurement
VAS, clinician examination and direct interview with patient
Intervention groups
1
Description
Group A: 2mg of Bupivacaine 0.5% hyperbaric was injected by 24 gaguge Quincke spinal needle in L4,L5 space in sitting position.
Category
Treatment - Drugs
2
Description
Group B: 5mg of Bupivacaine 0.5% hyperbaric was injected by 24 gaguge Quincke spinal needle in L4,L5 space in sitting position.