Obturator Nerve Block in Patients With Hip Fracture (OPAD)
Primary Purpose
Hip Fractures
Status
Withdrawn
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Bupivacaine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures
Eligibility 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
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Local anesthetic
Saline
Arm Description
15 ml. of local anesthetic
15 ml. of saline
Outcomes
Primary Outcome Measures
Success rate of successful analgesia
Success rate of successful analgesia 20 minutes after a supplementary obturator nerve block in patients with hip fracture
Secondary Outcome Measures
Time used for the procedure
Time from start of ultrasound scanning to end of injection of local anesthetic or placebo
Success rate of possible sonographic visualization
Success rate of possible sonographic visualization of necessary anatomical structures i order to do the nerve block
Time to analgesia
Time from end of injection of local anesthetic to analgesia
Full Information
NCT ID
NCT02408419
First Posted
March 31, 2015
Last Updated
September 11, 2015
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT02408419
Brief Title
Obturator Nerve Block in Patients With Hip Fracture
Acronym
OPAD
Official Title
Proximal Obturator Nerve Block After Insufficient Analgesic Effect of Femoral Nerve Block in Patients With Hip Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
The study was completely redesigned
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
About 10-30% of all patients with hip fracture have only insufficient analgesic effect of a femoral nerve block. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves occasionally are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve.
With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve.
The aim of this trail is to give patients with hip fracture and only insufficient effect of a femoral nerve block a supplementary obturator nerve block in a randomized manner with either local anesthetics or placebo in order to access the preoperative analgesic effect.
Detailed Description
About 10-30% of all patients with hip fracture have only insufficient analgesic effect of a femoral nerve block. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves occasionally are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve. Earlier it was believed that the so called '3-in-1-block' or the iliac fascia compartment block would anesthetize also the obturator nerve, and these two nerve blocks have been uses extensively in the emergency ward for preoperative analgesia. Today that is not believed to be true and consequently is the part of the obturator nerve in patients with hip fracture unknown.
With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve before it branches into an anterior and a posterior branch. A selective nerve block af the obturator nerve to access its effect in patients with hip fracture has to our knowledge never been done.
The aim of this trail is to give patients with hip fracture and only insufficient effect of a femoral nerve block a supplementary obturator nerve block in a randomized manner with either local anesthetics or placebo in order to access the preoperative analgesic effect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local anesthetic
Arm Type
Experimental
Arm Description
15 ml. of local anesthetic
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
15 ml. of saline
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Bupivacaine is injected proximally to anesthetize the obturator nerve
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Solution of sodium chloride
Intervention Description
Saline is injected as a placebo
Primary Outcome Measure Information:
Title
Success rate of successful analgesia
Description
Success rate of successful analgesia 20 minutes after a supplementary obturator nerve block in patients with hip fracture
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Time used for the procedure
Description
Time from start of ultrasound scanning to end of injection of local anesthetic or placebo
Time Frame
Expected average of 5 minutes
Title
Success rate of possible sonographic visualization
Description
Success rate of possible sonographic visualization of necessary anatomical structures i order to do the nerve block
Time Frame
Expected average of 5 minutes
Title
Time to analgesia
Description
Time from end of injection of local anesthetic to analgesia
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas F. Bendtsen, MD, Ph.d.
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
33238043
Citation
Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
Results Reference
derived
Learn more about this trial
Obturator Nerve Block in Patients With Hip Fracture
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