The aim of this study is determining the effects of adding Fentanyl to Bupivacaine in spinal anesthesia in opium addicted patients. This study is a randomized double blind clinical trial on 60 male opium addicted patients who are admitted for lower abdomen and extremity surgeries.
Inclusion criteria are; patients’ consent for spinal anesthesia, lower abdomen and extremity surgery , patient who consumes opium orally or by inhalation and shows withdrawal symptoms if do not consume it.
Exclusion criteria are using other sort of narcotics by the patient and history of pulmonary or cardiac diseases.
The patients are divided into two groups of 30 ones, randomly. In this study we use simple sampling method and selecting the simple sample is executed by draw. Patients in first group undergo spinal anesthesia with 12.5 mg Bupivacaine plus 0.5 ml sterile instilled water and in another group spinal anesthesia is performed using 12.5 mg bupivacaine and 25µg fentanyl.
In operative room 750 ml Ringers is given to them firstly and their vital signs are measured and documented. Midazolam 1mg is given to patient for relaxation and the level of senselessness is determined by skin test using a needle. The patients who do not reach to desired level (T10) are dismissed from the study. The time of asking analgesic by the patient is considered as the time of beginning the pain. During the surgery the patients’ vital signs are recorded every 5 minutes and in recovery room every 15 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012092210900N1
Registration date:2013-09-22, 1392/06/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-22, 1392/06/31
Registrant information
Name
Hosein Sattari
Name of organization / entity
kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2250
Email address
sattari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2012-08-01, 1391/05/11
Expected recruitment end date
2013-03-01, 1391/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of adding Fentanyl to Bupivacaine in spinal anesthesia in opium addicted patients
Public title
Comparison of two method of spinal anesthesia in opium addicts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) patient's consent of spinal anesthesia.
2) The patient who are admitted for lower abdomen and lower extremity surgery.
3) patients who are in the age range of 65-15 year
4) Patients in the height range between 185 - 150 cm
5)opium addict is a person who have used opium orally or inhales it at least for one year
6) surgery length of 80 to 150 minutes
7) No history of other drug abuse and psychological disorders.
8) Weight between 50 to 85 kg.
exclusion criteria:
1- consuming other kinds of drugs
2- history of pulmonary or cardiac diseases
3-history of disorders which have absolute or partial contraindication for spinal anesthesia
4- history of hypersensitivity to fentanyl or bupivacaine.
Age
From 15 years old to 65 years old
Gender
Male
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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
After approving by Ethic Committee of Kerman University of Medical Sciences, informed consent will be obtained from the patients. The method of sampling is simple randomization which amongst studied members of community who are referred to operation rooms of Afzalipoor, Shafa and Bahonar hospitals of kerman, one sample will be selected from the listed groups in the chances box by the patient accidentally. The medication is prepared by study leader and the anesthesiologist and technician who are responsible for taking care of the patient are blind to the medication as well as the patient. The preparation of patients in both group are similar and all the patients must be NPO for 8 hours before operation. The patients are notified of consuming regular opium as their usual pattern.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical sciences
Street address
Jomhoori boulevard
City
Kerman
Postal code
Approval date
2012-05-19, 1391/02/30
Ethics committee reference number
k/91/41
Health conditions studied
1
Description of health condition studied
Opium Addiction
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
the onset of pain after surgery
Timepoint
after operation
Method of measurement
asking the patient
Secondary outcomes
1
Description
blood pressure
Timepoint
every 5 minutes and every 15 minutes in PACU
Method of measurement
digital monitoring device
2
Description
the length of sensory nerves block
Timepoint
at 40,50,60,70,80,90,100,110 and 120 minutes
Method of measurement
skin stimulation test
3
Description
the length of motor nerves block
Timepoint
at 40,50,60,70,80,90,100,110 and 120 minutes
Method of measurement
asking the patient to move his legs
4
Description
the time of onset the analgesia
Timepoint
after performing the procedure
Method of measurement
skin stimulation test
5
Description
nausea and vomiting
Timepoint
throughout the operation and in PACU
Method of measurement
asking the patient
6
Description
Itching
Timepoint
throughout the operation and in PACU
Method of measurement
asking the patient
7
Description
Shivering
Timepoint
throughout the operation and in PACU
Method of measurement
observation
Intervention groups
1
Description
Patients in control group undergo spinal anesthesia with 12.5 mg Bupivacaine (20mg/4ml, manufactured by ICI Pharmaceuticals India Limited) plus 0.5 ml sterile instilled water
Category
Treatment - Drugs
2
Description
In intervention group spinal anesthesia is performed using 12.5 mg bupivacaine (20mg/4ml, made by ICI Pharmaceuticals India Limited) and 25µg fentanyl (0.5mg/10ml, manufactured by Aburaihan Co.Iran).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipoor hospital
Full name of responsible person
Azam Karimi
Street address
Afzalipoor Hospital
City
Kerman
2
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Azam Karimi
Street address
St. shafa, Shafa Hospital
City
Kerman
3
Recruitment center
Name of recruitment center
Bahonar Hospital
Full name of responsible person
Azam Karimi
Street address
Bahonar Hospital
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Azam Karimi
Position
Resident of anesthesia
Other areas of specialty/work
Street address
Afzalipoor Hospital
City
Kerman
Postal code
Phone
+98 34 1322 2250
Fax
Email
javakrd34@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hoseyn Sattari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Afzalipoor Hospital
City
Kerman
Postal code
Phone
+98 34 1322 2250
Fax
Email
hosattatri@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Azam Karimi
Position
Resident of anesthesia
Other areas of specialty/work
Street address
Afzalipoor Hospital
City
Kerman
Postal code
Phone
+98 34 1322 2250
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)