Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
21 September 2015 |
Main ID: |
NCT02408419 |
Date of registration:
|
31/03/2015 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Obturator Nerve Block in Patients With Hip Fracture
OPAD |
Scientific title:
|
Proximal Obturator Nerve Block After Insufficient Analgesic Effect of Femoral Nerve Block in Patients With Hip Fracture |
Date of first enrolment:
|
March 2015 |
Target sample size:
|
0 |
Recruitment status: |
Withdrawn |
URL:
|
https://clinicaltrials.gov/show/NCT02408419 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
Phase:
|
Phase 4
|
|
Countries of recruitment
|
Denmark
| | | | | | | |
Contacts
|
Name:
|
Thomas F. Bendtsen, MD, Ph.d. |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Aarhus University Hospital |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Clinical suspicion of hip fracture
- Successful sensory cutaneous effect of the femoral nerve block
- Age = 55 years
- Mentally capable of comprehending and using verbal pain score
- Mentally capable of differentiating between pain from the fractured hip and pain from
other locations
- Mentally capable of understanding the given information
- Arrival in the emergency room at times when one of the doctors who do the nerve
blocks for this investigation are on call
- Possible sonographic visualization of the structures needed for the nerve block
- Verbal numeric pain scale score (NRS 0-10) > 5 with passive leg raise of the
fractured leg at the time of inclusion OR NRS > 3 at rest, 30 minutes after a femoral
nerve block
- Patients informed consent
Exclusion Criteria:
- Hip fracture not confirmed by x-ray
- Weight < 45 kg
- Patient has previously been included in this trial
- If the patient wishes to be excluded
- Allergy to local anesthetics or adrenocortical hormone
- Visible infection in the area of the point of needle injection
Age minimum:
55 Years
Age maximum:
N/A
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Hip Fractures
|
Intervention(s)
|
Drug: Saline
|
Drug: Bupivacaine
|
Primary Outcome(s)
|
Success rate of successful analgesia
[Time Frame: 20 minutes]
|
Secondary Outcome(s)
|
Success rate of possible sonographic visualization
[Time Frame: Expected average of 5 minutes]
|
Time to analgesia
[Time Frame: 20 minutes]
|
Time used for the procedure
[Time Frame: Expected average of 5 minutes]
|
Secondary ID(s)
|
protocol2tdn
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|