Hip FracturesPhase 4NCT02540837
Obturator and Femoral Nerve Block in Patients With Hip Fracture
A Phase 4 study testing Bupivacaine and Saline in people with Hip Fractures, run by University of Aarhus at 1 site in Denmark.
Trial summary
A higher number than expected of patients with hip fracture have only insufficient analgesic effect of a femoral nerve block, which is the nerve block commonly used for this group of patients. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Bupivacaine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Apr 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical suspicion of hip fracture
- 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
- Verbal numeric pain scale score (NRS 0-10) > 5 with a dynamic test OR NRS > 3 at rest
- Patients informed consent
Who cannot join
- Hip fracture not confirmed by x-ray
- Weight < 40 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Aarhus, 8000
Thomas D. Nielsen, MD, +45 28782877, thomas.dahl.nielsen@clin.au.dk
Thomas F. Bendtsen, MD, Ph.d., +45 51542997, tfb@dadlnet.dk
About this study
Official title: Analgesic Effect of an Obturator Nerve Block Combined With a Femoral Nerve Block Compared With Femoral Nerve Block Alone in Patients With Hip Fracture
A higher number than expected of patients with hip fracture have only insufficient analgesic effect of a femoral nerve block, which is the nerve block commonly used for this group of patients. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves 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 trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.
Read the detailed description
A higher number than expected 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 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 of the obturator nerve to access its effect in patients with hip fracture has to our knowledge never been done.
The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.
- Conditions
- Hip Fractures
- Being tested
- Bupivacaine, Saline
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Active nerve block
Obturator nerve block
SalineDrug
Also called Placebo
Obturator nerve block with saline(placebo)
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Experimental | Obturator nerve block Receives: Drug: Bupivacaine |
| Saline | Placebo comparator | Saline is injected as a placebo Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of successful analgesia, measured with numeric rating scale(NRS) 0-10 with 0=no pain and 10=worst pain. Successful analgesia = NRS<4 at rest and NRS <6 with passive movement of the fractured leg.
Success rate of successful analgesia compared between the groups
Measured: 30 minutes
Secondary outcomes (18)
Median pain score (NRS 0-10)
Median pain score 30 minutes after the nerve blocks compared between the groups
Measured: 30 minutes
Median change in pain score (NRS 0-10)
Median change in pain score 30 minutes after the nerve blocks compared between the groups
Measured: 30 minutes
Course in pain reduction
Course in pain reduction during the 30 minutes after the nerve blocks
Measured: 30 minutes
Time to sufficient analgesia
Time from ended injection until sufficient analgesia
Measured: 30 minutes
Frequency of anesthesia in the skin area of the saphenous nerve
Frequency of anesthesia in the skin area innervated by the saphenous nerve
Measured: 30 minutes
Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
Measured: 30 minutes
Localization of the worst pain before block
Localization of the worst pain before any nerve blocks
Measured: 0 minutes
Localization of the worst pain after block
Localization of the worst pain 30 minutes after the nerve blocks
Measured: 30 minutes
Discomfort during nerve block procedures (score 0-10, 0=no discomfort)
Discomfort during the nerve block procedures compared between procedures
Measured: 5 minutes
Satisfaction (0-10, 0= very unsatisfactory)
Patient satisfaction with the pain treatment
Measured: 30 minutes
Frequency of ultrasound visualization of femoral nerve
Frequency of patients with possible ultrasound visualization af the femoral nerve
Measured: 5 minutes
Frequency of ultrasound visualization of obturator injection site
Frequency of patients with possible ultrasound visualization of the obturator nerve block injection site
Measured: 5 minutes
Time spend on femoral nerve block
Time spend on conducting the femoral nerve block
Measured: 5 minutes
Time spend on obturator nerve block
Time spend on conducting the obturator nerve block
Measured: 5 minutes
Total morphine equivalent dose of opioid from the time of nerve block to operation
Total morphine equivalent dose of opioid from the time of nerve block until the time of operation
Measured: Approximately 24 hours in average
Total morphine equivalent dose of opioid/time from the time of nerve block to operation
Total morphine equivalent dose of opioid/time from the time of nerve block until the time of operation
Measured: Approximately 24 hours in average
Total morphine equivalent dose of opioid in the first 10 hours after nerve block
Total morphine equivalent dose of opioid given in the first 10 hours after nerve block
Measured: 10 hours
Total morphine equivalent dose of opioid/time in the first 10 hours after nerve block
Total morphine equivalent dose of opioid/time given in the first 10 hours after nerve block
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas F. Bendtsen, Ph.d., Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540837
- Sponsor's protocol ID
- protocol2_2tdn
- Status last verified
- May 2016
- First submitted
- 27 Aug 2015
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of an Obturator Nerve Block Combined With a Femoral Nerve Block Compared With Femoral Nerve Block Alone in Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT02540837
- Acronym / sponsor ID
- protocol2_2tdn
- Conditions
- Hip Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A higher number than expected of patients with hip fracture have only insufficient analgesic effect of a femoral nerve block, which is the nerve block commonly used for this group of patients. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves 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 trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.
Detailed description
A higher number than expected 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 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 of the obturator nerve to access its effect in patients with hip fracture has to our knowledge never been done.
The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Experimental | Drug: BupivacaineObturator nerve block |
| Saline | Placebo comparator | Drug: SalineSaline is injected as a placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical suspicion of hip fracture
- 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
Key exclusion criteria (6 listed)
- Hip fracture not confirmed by x-ray
- Weight < 40 kg
- Patient has previously been included in this trial
- If the patient wishes to be excluded
- Allergy to local anesthetics or adrenocortical hormone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: Active nerve blockObturator nerve block | Drug | Bupivacaine |
| SalineAlso: PlaceboObturator nerve block with saline(placebo) | Drug | Saline |
Primary outcome
Success rate of successful analgesia, measured with numeric rating scale(NRS) 0-10 with 0=no pain and 10=worst pain. Successful analgesia = NRS<4 at rest and NRS <6 with passive movement of the fractured leg.
Time frame: 30 minutes
Success rate of successful analgesia compared between the groups
18 secondary outcomes
Median pain score (NRS 0-10)
Time frame: 30 minutes
Median change in pain score (NRS 0-10)
Time frame: 30 minutes
Course in pain reduction
Time frame: 30 minutes
Time to sufficient analgesia
Time frame: 30 minutes
Frequency of anesthesia in the skin area of the saphenous nerve
Time frame: 30 minutes
Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
Time frame: 30 minutes
Localization of the worst pain before block
Time frame: 0 minutes
Localization of the worst pain after block
Time frame: 30 minutes
Discomfort during nerve block procedures (score 0-10, 0=no discomfort)
Time frame: 5 minutes
Satisfaction (0-10, 0= very unsatisfactory)
Time frame: 30 minutes
Frequency of ultrasound visualization of femoral nerve
Time frame: 5 minutes
Frequency of ultrasound visualization of obturator injection site
Time frame: 5 minutes
Time spend on femoral nerve block
Time frame: 5 minutes
Time spend on obturator nerve block
Time frame: 5 minutes
Total morphine equivalent dose of opioid from the time of nerve block to operation
Time frame: Approximately 24 hours in average
Total morphine equivalent dose of opioid/time from the time of nerve block to operation
Time frame: Approximately 24 hours in average
Total morphine equivalent dose of opioid in the first 10 hours after nerve block
Time frame: 10 hours
Total morphine equivalent dose of opioid/time in the first 10 hours after nerve block
Time frame: 10 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
Related trials for Hip Fractures
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas F. Bendtsen, Ph.d. study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine and Saline in people with Hip Fractures, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas D. Nielsen, M.D. (+45 28782877, thomas.dahl.nielsen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of successful analgesia, measured with numeric rating scale(NRS) 0-10 with 0=no pain and 10=worst pain. Successful analgesia = NRS<4 at rest and NRS <6 with passive movement of the fractured leg. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.