Background & purpose : Saddle block is the method of choice for anorectal surgery. By increasing outpatient surgeries, attempts are carried out to substitute Lidocaine with other drugs or lowering its dose to decrease complications and rapid reversal of sensory and motor blocks. This study is designed to compare sensory and motor block level with 0.5 versus 1cc Lidocaine5% in saddle block for anorectal surgery.
Design of experiments: Single blind clinical trial
Methods: Patients randomly divided into 50 ml Lidocaine 5% 1cc and 25 ml Lidocaine 5% 0.5cc groups.
Inclusion criteria: 60 patients candidate for elective anorecctal surgery at the age of 18-60 and set in class I & II of Anesthesia Society of America (ASA) was selected,
Exclusion criteria: Patients with history of cardiovascular disease, psychologic, chronic pain, lung disase and opioids or alcohol dependency.
Intervention: 1cc Lidocaine 5% for 30 patients and 0.5cc Lidocaine 5% for another 30 patients was injected in to intratecal space and both groups remained seated for 5 minutes and then they were placed in appropriate position for surgery. Main outcomes: Sensory block level, motor block level,pain, hemodynamic changes,nausea and vomiting .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311196744N2
Registration date:2014-04-11, 1393/01/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-11, 1393/01/22
Registrant information
Name
Mehrafza Mir
Name of organization / entity
Babol university of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
mmir46@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research, Babol University Of Medical Sciences
Expected recruitment start date
2012-08-01, 1391/05/11
Expected recruitment end date
2012-12-31, 1391/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial a comparision of sensory and motor block level between 0.5 vs 1cc Lidocaine 5% in saddle anesthesia for anorectal surgery
Public title
A comparision of sensory and motor block level between 0.5 vs 1cc Lidocaine 5% in saddle anesthesia for anorectal surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterion: patients candidate for elective anorectal surgery set in class I & II of Anesthesia Society of America (ASA) was selected.
Exclusion criteria: patients with history of cardiovascular disease, psychologic, chronic pain, lung disase and opioids or alcohol dependency.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Approval date
2012-07-01, 1391/04/11
Ethics committee reference number
6446 /30/ژ/پ
Health conditions studied
1
Description of health condition studied
Post spinal blockade analgesia
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
2
Description
Level of motor block
Timepoint
Every one minute until 15 minutes and then every 5 minutes until the end of block
Method of measurement
Ability to flex and extend thigh, knee, ankle
3
Description
Analgesia during surgery and after that
Timepoint
During surgery and 24 hours after that
Method of measurement
Pain score
Secondary outcomes
1
Description
Blood pressure
Timepoint
Every one minute until 15 minutes and then every 5 minutes until the end of block
Method of measurement
Non- invasive manometer
2
Description
Heart rate
Timepoint
Every one minute until 15 minutes and then every 5 minutes until the end of block
Method of measurement
Heat rate monitoring
3
Description
Nausea and vomiting
Timepoint
From begining to end of the block
Method of measurement
Observation and inquiry
Intervention groups
1
Description
Prevention group: Interatechal injection of 0.5 cc Lidocaine 5%
Category
Prevention
2
Description
Control group: Injection of 1 cc Lidocaine 5%
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Mehrafza Mir
Street address
Shahid Ghasemi Avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor Of Research Babol University Of Medical Sciences
Full name of responsible person
Dr Amrolah Mostafazadeh
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor Of Research Babol University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Mehrafza Mir
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
mmir46@yahoo.com; ans_dep@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Mosataffa Faraji
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
mmir46@yahoo.com; ans_dep@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Mehrafza Mir
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
mmir46@yahoo.com; ans_dep@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)