Comparison of anesthesia level of intrathecal injection after 1 and 1.5 cc bupivacaine 0.5% in saddle block
Design
A clinical trial without a control group, with parallel groups, without blinding, was randomized and 80 patients with a size of 4 blocks would be randomly assigned to two groups.
Settings and conduct
The study population was patients aged 18-65 years referred to the Babol Spiritual Educational and Medical Center. Patients arerandomly divided into two groups using a random number table by computer.Intervention group1: To create nerve block, 1 cc bupivacaine 0.5% (Abu Reihan Pharmacy) is injected once into the intrathecal space.
Intervention group2: To create nerve block, 1.5 cc bupivacaine 0.5% (Abu Reihan Pharmacy) is injected once into the intrathecal space.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: class I & II of Anesthesia Society of America (ASA) and patients candidate for elective peri Anal surgery
Exclusion Criteria:Cardiovascular disease, Chronic pain, lung disease, Opioids or alcohol dependency
Intervention groups
Intervention group1: To create nerve block, 1 cc bupivacaine 0.5% (Abu Reihan Pharmacy) is injected once into the intrathecal space.
Intervention group2: To create nerve block, 1.5 cc bupivacaine 0.5% (Abu Reihan Pharmacy) is injected once into the intrathecal space.
Main outcome variables
Sensory block level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190529043750N3
Registration date:2021-06-28, 1400/04/07
Registration timing:prospective
Last update:2021-06-28, 1400/04/07
Update count:0
Registration date
2021-06-28, 1400/04/07
Registrant information
Name
mohammad esmaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 8305
Email address
dresmaeili48@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-27, 1400/05/05
Expected recruitment end date
2022-07-27, 1401/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anesthesia level of intrathecal injection after 1 and 1.5 cc bupivacaine 0.5% in saddle block
Public title
Comparison of anesthesia levels of intrathecal bupivacaine injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
class I & II of Anesthesia Society of America (ASA)
patients candidate for elective peri Anal surgery
Exclusion criteria:
Cardiovascular disease
Chronic pain
lung disease
Opioids or alcohol dependency
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups of 40 using 4 blocks and a ratio of 1: 1. The free website www.randomization.com will be used to generate the allocation sequence. The resulting sequence will be written on separate sheets and placed in sealed envelopes and will be provided to the lead researcher for study.
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 Babol University of Medical Siences
Street address
Babol University of Medical Sciences, Gangafrooz Street, Daneshgah Square, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
471764136
Approval date
2021-06-15, 1400/03/25
Ethics committee reference number
IR.MUBABOL.REC.1400.152
Health conditions studied
1
Description of health condition studied
Sensory block level
ICD-10 code
T88.8
ICD-10 code description
Other specified complications of surgical and medical care, not elsewhere classified
Primary outcomes
1
Description
Level of sensory block
Timepoint
Every one minute until 15 minutes and then every 5 minutes until the end of block
Method of measurement
Use of alcohol conteminated cotton and niddle number 20
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: To create nerve block, 1 cc bupivacaine 0.5% (Abu Reihan Pharmacy) is injected once into the intrathecal space.
Category
Treatment - Drugs
2
Description
Intervention group:To create nerve block, 1.5 cc bupivacaine 0.5% (Abu Reihan Pharmacy) is injected once into the intrathecal space.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Mohammad Esmaeili
Street address
Ganjafrooz Avenue, Daneshgah Square, Ruhani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3233 8301
Email
dresmaeili48@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?