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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: University of Aarhus
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Recruitment status: Withdrawn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
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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