Comparison duration of spinal anesthesia between Lidocain5% and Lidocain5% plus Epinephrine in chronic Opium addiction patients and non addiction patients in lower extremity orthopedic surgery
Aim: the aim of the study was to compare of the duration of spinal anesthesia with 5% Lidocaine and 5% Lidocaine coupled with Epinephrine in chronic opium abusers and nonabusers with Lower extremities orthopedic surgery.
Design: this clinical trial study was conducted with random allocation and unilateral blinded designed.
Method: In this study, the eligible chronic opium abusers and nonabusers randomly allocated into one of two sub groups of methods were available. One sub group was injected with 75 mg of 5% Lidocaine and another sub group was injected with 75 mg of 5% Lidocaine coupled with 0.2 mg Epinephrin in subarachnoid space between the third and fourth lumbar vertebrae. The level of primary sensory was brought to sixth lumbar vertebrae with Changes in the operating room bed slope when the patient was in supine position. Then every ten minutes, the patient's flank was stimulated with a needle for determining the level of sensory. The returning time of 4 levels of sensory to the primary level of sensory were measured and were supposed as Criterion.
Participants: Two hundred and one chronic opium abusers and nonabusers with Lower extremities orthopedic surgery were randomly assigned to receive 5% Lidocaine or 5% Lidocaine coupled with Epinephrine for spinal anesthesia in 9 months interval in Kerman.
The main outcome variable: assessment of duration of spinal anesthesia with 5% Lidocaine and so the effect of 5% Lidocaine coupled with Epinephrine on the period of spinal anesthesia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110097745N1
Registration date:2011-11-22, 1390/09/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-22, 1390/09/01
Registrant information
Name
Afshin Mansourian
Name of organization / entity
YUMS
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 0620
Email address
afshin.mansourian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research University of medical Sciences,Kerman medical University
Expected recruitment start date
2010-07-27, 1389/05/05
Expected recruitment end date
2011-04-22, 1390/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison duration of spinal anesthesia between Lidocain5% and Lidocain5% plus Epinephrine in chronic Opium addiction patients and non addiction patients in lower extremity orthopedic surgery
Public title
Spinal anesthesia with Lidocain
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria:
1 –patients with higher or lower then sixth lumbar vertebrae's primary sensory level of anesthesia
2- Individuals with BMI (Body Mass Index) more than 30 kg/m2 and less than 20 kg/m2
3- Alcohol abusers
4- Patients who refuse spinal anesthesia
5-patients with Less than one year of opium abusers in addicted group
6- Substance abuse in less than 2 last years for patients in non addicted group
7- Substance abusers other than opium
8- Patients who had developed neuropathy formerly or at present
Inclusion criteria:
1- Fifteen to sixty five years old men with 150 to 180 centimeters in height
2- Drug addicted individuals with a history of more than one year abuse; specifically those who had shown withdrawal symptoms with abstention of drugs.
3- Patients who didn't use to any narcotic substances in less than 2 last years
** All information is based on the patient's statements.
Age
From 15 years old to 65 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
210
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 Kerman University of medical sciences
Street address
BVL Jahad, Neuroscience Research Center of Kerman medical University
City
kerman
Postal code
7619813159
Approval date
2011-05-25, 1390/03/04
Ethics committee reference number
ع/7-90
Health conditions studied
1
Description of health condition studied
Spinal anesthesia
ICD-10 code
y48-3
ICD-10 code description
Local anesthesia
Primary outcomes
1
Description
Duration of spinal anesthesia with Lidocain%5
Timepoint
after 10 minute
Method of measurement
after 10 minute with pinprick on abdomen each 10 minute e %5
Secondary outcomes
1
Description
height
Timepoint
At the time of admit ion
Method of measurement
by patient report
2
Description
age
Timepoint
At the time of admit ion
Method of measurement
by patient report
3
Description
body weight
Timepoint
At the time of admit ion
Method of measurement
by patient report
Intervention groups
1
Description
Addiction patients were selected according to our inclusion and exclusion criteria. All patients were visited the night before surgery and were informed about the study. In these patients were told to use their usual daily dose. All patients were NPO for 8 h before the scheduled surgical procedure. The anesthesiologist who performed the spinal anesthesia and documented the sensory level was blinded to the patient’s history of opium abuse. After standard monitoring (electrocardiogram, pulse oxymetry, noninvasive arterial blood pressure, and heart rate), the patients received 500–750 milliliter of lactated solution over 10–15min. Spinal anesthesia were performed with the patient in the sitting position under appropriate aseptic conditions. The L3–4 inter space was funded and with a 24-gauge Sprotte spinal needle was inserted via a midline approach. The needle bevel was oriented cephalic, while 75 milligrams of Lidocaine 5% with dextrose 7.5% was injected in some patients and 75 mg of Lidocaine 5% with dextrose 7.5% plus 0.2 milligrams Epinephrine was injected at a rate of 0.2 milliliter per second in other addicted patients. The patients were placed supine on surgical bed after drug injection. T6 level of sensory was achieved with the help of position maneuvers. Sensory level was assessed with pinprick flank of patient each 10 minute. The level of sensory was then checked and documented till sensory level received to T10. This time that decrease four level of sensory level was recorded and was based of our study
Category
Treatment - Other
2
Description
Non Addiction patients were selected according to our inclusion and exclusion criteria. All patients were visited the night before surgery and were informed about the study. All patients were NPO for 8 h before the scheduled surgical procedure. The anesthesiologist who performed the spinal anesthesia and documented the sensory level was blinded to the patient’s history of opium non abuse. After standard monitoring (electrocardiogram, pulse oxymetry, noninvasive arterial blood pressure, and heart rate), the patients received 500–750 milliliter of lactated solution over 10-15min. Spinal anesthesia were performed with the patient in the sitting position under appropriate aseptic conditions. The L3–4 inter space was funded and with a 24-gauge Sprotte spinal needle was inserted via a midline approach. The needle bevel was oriented cephalic, while 75 milligrams of Lidocaine 5% with dextrose 7.5% was injected in some patients, and 75 milligrams of Lidocaine 5%with dextrose 7.5% plus 0.2 milligrams Epinephrine was injected at a rate of 0.2 milliliter per second in other non addicted patients. The patients were placed supine on surgical bed after drug injection. T6 level of sensory was achieved with the help of position maneuvers. Sensory level was assessed with pinprick flank of patient each 10 minute. The level of sensory was then checked and documented till sensory level received to T10. This time that decrease four level of sensory level was recorded and was based of our study
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar Hospital
Full name of responsible person
Afshin Mansourian
Street address
Bahonar Hospital, Baghe Meli Square, Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Kerman University medical Sciences
Full name of responsible person
Doctor Reza Malekpour
Street address
Vice chancellor for research Kerman University medical Sciences ،BLV Jahad, Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Kerman University 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
Kerman University of medical sciences
Full name of responsible person
Afshin Mansourian
Position
Anesthesia resident
Other areas of specialty/work
Street address
Bahonar Hospital, Baghe Meli Square، Kerman
City
Kerman
Postal code
Phone
+98 34 1222 8034
Fax
Email
Afshin.mansourian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman university of medical Scienes
Full name of responsible person
Doctor Mohamad Askarzadeh
Position
Anesthesiologist-Assistant Professor, Atending
Other areas of specialty/work
Street address
Neruscience research Center, BVL Jahad, Kerman
City
Kerman
Postal code
Phone
+98 34 1222 8034
Fax
Email
Alirezaaskarzadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University medical Sciences
Full name of responsible person
Afshin Mansourian
Position
Anesthesia resident
Other areas of specialty/work
Street address
Bahonar Hospital, Baghe Meli Square, Kerman
City
Kerman
Postal code
Phone
+98 34 1222 3408
Fax
Email
Afshin.mansourian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)