Each year, a large number of orthopedic surgeries is due to femur and pelvic fractures. Because of the complex nature of these fractures, post-operative care is very important. We conducted a double blind Randomized Clinical Trial to study the effect of effect of bupivacaine 0.2% and 0.3% for analgesia after hip or femur surgery. The study population consist of 40 candidate for femur and pelvic surgery in Rasul akram and Firouzgar hospitals. Patients with disorders such as peripheral neuropathy, drug addiction and multiple trauma will have been excluded. Participants will be assigned to 2 groups(A and B) using block randomization. In each group alternatively, anesthetic drug be injected and injection site will be checked. Participants and anesthesiologist will not be aware of the nature of the drug(The study is double blind). In order to pain relief, acetaminophen injection will be used every 6 hours for all Patients after operation. Sedation score using Ramsy scale at 2, 6, 12, 24 and 48 hours after operation and pain Severity using Visual Analog Scale(VAS) will be assessed. furthermore,vomiting, changes in blood pressure and heart rate within 48 hours after operation will be recorded
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081014199N5
Registration date:2015-01-02, 1393/10/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-02, 1393/10/12
Registrant information
Name
Leila Mounesan
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 9763
Email address
l-mounesan@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between effect of bupivacaine 0.2% and 0.3% in ultrasound guided fascia iliaca plane block for analgesia after hip or femur surgery
Public title
Effect of bupivacaine for analgesia after hip or femur surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Any type of femur fracture, Any type of hip fracture, Individuals of all ages,Male and female, ASA eligibility criteria(ASA>=1), Informed consent. Exclusion criteria: Peripheral neuropathy, drug addiction, mental disorders, Allergic reactions to amide anesthetic drugs, Concurrent multiple fractures in different organs(Multiple Trauma)
Age
From 18 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences Central Campus, Shahid Hemmat Highway, Adjacent to Milad Tower, Tehran, Iran
City
Tehran
Postal code
Approval date
2013-09-13, 1392/06/22
Ethics committee reference number
130-243-د-92
Health conditions studied
1
Description of health condition studied
Postoperative pain
ICD-10 code
G89.18
ICD-10 code description
Pain during the period after surgery
Primary outcomes
1
Description
Postoperative pain
Timepoint
Pain score and sedation score were evaluated 2, 6, 12, 24 and 48 hours after operation(5 times)
Method of measurement
Two types of questionnaire: 1.Sedation score and 2. Visual Analog Scale
Secondary outcomes
1
Description
Heart rate
Timepoint
At 2, 6, 12, 24 and 48 hours after operation(5 times)
Method of measurement
Questionnaire (the number of heartbeats per minute)
2
Description
Patient satisfaction
Timepoint
Within 48 hours after operation(1 time)
Method of measurement
Questionnaire with likert scale (Low, moderate, good, excellent)
3
Description
Blood pressure
Timepoint
At 2, 6, 12, 24 and 48 hours after operation(5 times)
Method of measurement
Questionnaire (Mean of arterial blood pressure(With pressure gauge))
4
Description
Vomiting
Timepoint
At 2, 6, 12, 24 and 48 hours after operation(5 times)
Method of measurement
Questionnaire (Observation)
5
Description
Nausea
Timepoint
At 2, 6, 12, 24 and 48 hours after operation(5 times)
Method of measurement
Questionnaire (Self-declaration)
Intervention groups
1
Description
In group1: Injection Bupivacaine 0.2% (Manufacturer: Italy, Milan) in ultrasound guided fascia iliaca plane block
Category
Treatment - Drugs
2
Description
In group 2: Injection bupivacaine 0.3% (Manufacturer: Italy, Milan) in ultrasound guided fascia iliaca plane block