Postoperative pain can cause patient restlessness, cardiopulmonary complications, reduction of immune system function, hyperglycemia, urinary retention and ileus. Postoperative analgesia causes patient comfort and reduces morbidity, discharge time and hospital cost.In this single blind clinical trial 60 male or female with 18-65 years old that Scheduled for open reduction and internal fixation of femur fracture(neck, subtrochanteric and intertrochanteric) randomly assigne in spinal or general anesthesia after justification and obtaining consent. In intervention group 2ml of 0.5% hyperbaric bupivacaine will be injected in subarachnoid space through L3-L4 space sand block level up to T10 will be produced.In control group (general anesthesia) ) premedication will be fentanyl (1µg/kg) and midazolam(0.05mg/kg), induction of anesthesia thiopental Na (5mg/kg) and Atracurium (0.4mg/kg) for muscle relaxation, maintenance of anesthesia with administration of 1.5%> isoflurane and equal proportions of oxygen and Nitrous oxide. Measurable outcomes after operation are 1- postoperative pain that at the end of recovery and then every 4 hours up to 24 hours will bee assessed according to 0-10 numerical pain rating scale. 2- total injected pethedine dose in the first 24 hours and 3-end of operation to discharge time interval in hour also will be assessed. data analysis will be performed with SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052412123N5
Registration date:2016-06-06, 1395/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-06, 1395/03/17
Registrant information
Name
Javad Nourian
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 27 3334 2001
Email address
javadnourian@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Shahroud University of Medical Sciences
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of spinal anesthesia and general anesthesia on postoperative pain and patient discharge time in open femur fractured surgeries
Public title
Postoperative pain and discharge time after open reduction of femur fracture under spinal anesthesia and comparison with general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: male and female with 18-65 years old, open reduction and internal fixation of femur fractures(neck, subtrochanteric and intertrochanteric)
Exclusion: Patient's refusal, drug abuse, history of anticonvulsive or antidepresive medication, surgery or anesthesia complications
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Deputy of research, Shahroud University of Medical Sciences
Street address
Deputy of research, Shahroud University of Medical Sciences, 7th of Tir square
at the end of recovery and then every 4 hours up to 24 hours(before pethidine injection)
Method of measurement
0-10 Numerical pain rating scale( NPS )
2
Description
Discharge time
Timepoint
End of surgery to discharge from hospital
Method of measurement
hour
Secondary outcomes
1
Description
Total dose of pethidine
Timepoint
dose and time of each pethidine injection in recovery and in orthopedia ward in first postoperative day
Method of measurement
Milligram in first postoperative day
Intervention groups
1
Description
Control group: or general anesthesia group, premedication with 1.5 microgram/kg and midazolam 0.05 microgram/kg, Induction with thiopental Na 5 mg/kg and muscle relaxation with 0.4 mg/kg atracurium. Maintenance of anesthesia performs with equal proportion of O2/N2O and 1.5% isoflurane. Depth of anesthesia and muscle relaxation assessment will be controled
Category
Treatment - Drugs
2
Description
Intervention group: after justification and consent in a sterile situation a 25 gauge spinal needle will be inserted in subarachnoid space from L3-L4 intervertebral space. After injection of 2ml of 0.5% hyperbaric bupivacaine, supine position with 20 degree head and chest up position will be selected until the block level reaches to umbilical line( T10).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Operating room, Imam hossein hospital
Full name of responsible person
Dr Javad Nourian
Street address
Imam Hossein Hospital, operation room, End of Ayatollah Towhidi avenue
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research, Shahroud University of Medical Sciences
Full name of responsible person
Mohammad hasan Emamian
Street address
Deputy of research, Shahroud University of Medical Sciences, 7th of Tir square
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research, Shahroud 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
Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran
Full name of responsible person
Javad Nourian MD
Position
Assistant professor of anesthesiology, department of anesthesia and intensive care
Other areas of specialty/work
Street address
Imam Hossein Hospital, operation room, End of Towhidi avenue Shahroud
City
Shahroud
Postal code
3616911151
Phone
+98 23 3234 2001
Fax
+98 23 3233 3902
Email
javadnourian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran
Full name of responsible person
Javad Nourian MD
Position
Assistant professor of anesthesiology, department of anesthesia and intensive care
Other areas of specialty/work
Street address
Imam Hossein Hospital, operation room, End of Towhidi avenue Shahroud
City
Shahroud
Postal code
3616911151
Phone
+98 23 3234 2001
Fax
+98 23 3233 3902
Email
javadnourian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran
Full name of responsible person
Javad Nourian MD
Position
Assistant professor of anesthesiology, department of anesthesia and intensive care
Other areas of specialty/work
Street address
Imam Hossein Hospital, operation room, End of Ayatollah Towhidi avenue
City
Shahroud
Postal code
3616911151
Phone
+98 23 3234 2001
Fax
+98 23 3233 3902
Email
javadnourian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)