The aim of this study was to compare the duration of sensory and motor block and side effects of adding different doses of intrathecal fentanyl to lidocaine 5% in spinal anesthesia.
Inclusion criteria were: patients undergoing elective surgery in lower abdomen and lower extremities under spinal anesthesia and need for anesthesia to level of T10 was enrolled in a double blind placebo-controlled clinical trial.
Exclusion criteria: refusal of patient, infection of needle entrance, anatomical difficulty and neurologic diseases
Patient recruitment: 140 patients enrolled in a double blind clinical trial and randomly allocated to 4 surgery groups. For spinal anesthesia in all patients, 100 mg of 5% intrathecal lidocaine was used and based on the drug added, patients were randomly assigned to one of four groups of control with adding 2 ml distilled water to lidocaine and injected to spinal space, case group 1 with adding 25 microgram fentanyl and 1.5 cc distilled water and injected to spinal space, case group 2 with adding 50 microgram fentanyl and 1 cc distilled water and injected to spinal space and case group 3 with adding 100 microgram fentanyl and injected to spinal space. Duration time of sensory and motor block and the occurrence of complications were evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103303289N2
Registration date:2011-06-13, 1390/03/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-13, 1390/03/23
Registrant information
Name
Esmail Moshiri
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
dr_moshiri@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for research
Expected recruitment start date
2008-03-19, 1386/12/29
Expected recruitment end date
2009-03-20, 1387/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the duration of sensory block and side effects of adding different doses of intrathecal fentanyl to lidocaine 5% in spinal anesthesia
Public title
Effect of opioid on duration of spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 15-65 y; physical status: ASA I and II; need for anesthesia below T10
Exclusion criteria: Patient refusal; Infection in needle entrance; Anatomical difficulty; Neurological diseases
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Mardom Park - Hamedan
City
Hamedan
Postal code
Approval date
2008-08-31, 1387/06/10
Ethics committee reference number
72229/9/35/16/پ
Health conditions studied
1
Description of health condition studied
local anesthesia
ICD-10 code
Y45.0, Y48
ICD-10 code description
Opioids and related analgesics,Local anaesthetics
Primary outcomes
1
Description
start of sensory block
Timepoint
before block every 1 min- then every 5 min
Method of measurement
cold sensation
2
Description
duration of sensory block
Timepoint
before block every 1 min- then every 5 min
Method of measurement
cold sensation
3
Description
start of motor block
Timepoint
every 5 min
Method of measurement
inability to move foot finger
4
Description
duration of motor block
Timepoint
every 5 min
Method of measurement
ability to move foot finger
Secondary outcomes
1
Description
end of sensory block
Timepoint
every 5 min
Method of measurement
cold sensation
2
Description
end of motor block
Timepoint
every 5 min
Method of measurement
moving fingers
Intervention groups
1
Description
control group:lidocaine 5%+distilled water 2 cc and injection to spinal space
Category
Treatment - Drugs
2
Description
case group 1:lidocaine 5%+fentanyl 25 mic +distilled water 1.5 cc and injection to spinal space
Category
Treatment - Drugs
3
Description
case group 2:lidocaine 5%+fentanyl 50 mic +distilled water 1 cc and injection to spinal space
Category
Treatment - Drugs
4
Description
case group 3:lidocaine 5%+fentanyl 100 mic and injection to spinal space
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan University of Medical Scienses
Full name of responsible person
Ebrahim Khoshraftar,MD
Street address
Operating Room- Besat Hospital- Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Scienses - Research Deputy
Full name of responsible person
Abbas Zamanian,MD
Street address
Research Deputy - Medical Facaulty - Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Scienses - Research Deputy
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
Hamedan University of Medical Sciences
Full name of responsible person
Ebrahim Khoshraftar,MD - Scientific Staff of Medical Faculty - Anesthesia Group
Position
Asspciated professor,Anesthetist
Other areas of specialty/work
Street address
Besat hospital,Hamedan
City
Hamedan
Postal code
Phone
+98 81 1264 0041
Fax
Email
khoshraftar@umsha.ac.ir
Web page address
http://www.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Esmail moshiri,MD - Scientific Staff of Arak Medical Faculty - Anesthesia Group
Position
Associated Professor,Anesthetist
Other areas of specialty/work
Street address
Vali-Asr Hospital , Arak
City
Arak
Postal code
Phone
+98 918 161 3358
Fax
Email
dr_moshiri@arakmu.ac.ir
Web page address
http://www.arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ebrahim Khoshraftar MD
Position
Associated Professor,Anesthetist
Other areas of specialty/work
Street address
Besat Hospital,Hamedan
City
Hamedan
Postal code
Phone
+98 81 1264 0041
Fax
Email
khoshraftar@umsha.ac.ir
Web page address
http://www.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)