Hip FracturePhase 4NCT02248870
Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture
A Phase 4 study testing Dexamethasone and Saline in people with Hip Fracture, run by University of Aarhus at 1 site in Denmark.
Trial summary
Prolongation of the analgesic effect of a femoral nerve block from the present 15 hours to 24 hours in patients with hip fracture would have a major impact in order to provide better preoperative analgesia for this group. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Dexamethasone and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Sep 2015
- 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 pain score (0-10) ≥ 7 with passive leg raise of the fractured leg at the time of inclusion
- Patients informed consent
Who cannot join
- Hip fracture not confirmed by x-ray
- Weight < 40 kg
- Verbal pain score > 3, 30 minutes after the nerve block
- Verbal pain score > 5 with passive leg raise, 30 minutes after the nerve block
- Patient has previously been included in this trial
- Ongoing pre traumatic treatment with parenteral or intravenous adrenocortical hormone
Show all 11Show fewer
- Verbal pain score > 3 from other locations than the fractured hip
- 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
- Acute inability to comprehend and use verbal pain score
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Duration af a Preoperative Single-shot Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture
Prolongation of the analgesic effect of a femoral nerve block from the present 15 hours to 24 hours in patients with hip fracture would have a major impact in order to provide better preoperative analgesia for this group.
In other trials concerning other nerves then the femoral nerve the addition of Dexamethasone to the local anesthetics doubled the analgesic duration. No studies has investigated the effect of the addition of Dexamethasone to the femoral nerve block in patients with hip fracture.
The aim of our study is to investigate if more patients with hip fracture experience lasting preoperative analgesia until the time of operation or 20 hours after a femoral nerve block with the addition of Dexamethasone compared to the same nerve block done without Dexamethasone.
Read the detailed description
Patients with hip fractures are most often old, have multiple comorbidities and suffer severe pain.
Femoral nerve block as a means of preoperative analgesia for these patients has proven effective in multiple trials for the majority of the patients. Still some issues remains to be investigated in order to optimize the preoperative analgesia for this group.
One of the issues that reduces the feasibility of the femoral nerve block is the relatively shorter analgesic duration of the nerve block compared to the often longer time from the hospital admission to the actual operation. From the literature and our own experience the mean analgesic duration of a femoral nerve block approximates 15 hours.
Many studies have shown a prolonged analgesic duration of different nerve blocks when Dexamethasone was added to the local anesthetics. Some studies show a 100 percent increase in duration.
To our knowledge no studies have been published regarding prolongation of the analgesic effect of the femoral nerve block with Dexamethasone, and also none regarding the group of patients with hip fracture.
The clinical impact of a femoral nerve block with an analgesic duration of 20 hours compared to the present 15 hours would be less patients waking up in wards during the night time with pain and a terminated femoral nerve block.
The purpose of this study is to investigate if more patients with hip fracture experience a lasting preoperative analgesic duration of at least 20 hours or until the time of operation after a femoral nerve block with Bupivacaine with adrenaline and the addition of Dexamethasone compared to the same nerve block done with only Bupivacaine with adrenaline.
- Conditions
- Hip Fracture
- Being tested
- Dexamethasone, Saline
- Keywords
- femoral neck
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone is added to Bupivacaine with Adrenaline for perineural injection
SalineDrug
Also called Solution of sodium chloride
Saline is added as a placebo to Bupivacaine with adrenaline for perineural injection
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Bupivacaine with adrenaline with 2 ml. of Saline added Receives: Drug: Saline |
| Dexamethasone | Experimental | Bupivacaine with adrenaline with 2 ml. of Dexamethasone added Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of analgesia at the time of operation or at 20 hours
Frequency of analgesia at the time of operation or at 20 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
Measured: Until the start of the operation or at 20 hours, average 18 hours
Secondary outcomes (16)
Frequency of analgesia at the time of operation or at 22 hours
Frequency of analgesia at the time of operation or at 22 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
Measured: Until the start of the operation or at 22 hours, average 20 hours
Frequency of analgesia at the time of operation or at 24 hours
Frequency of analgesia at the time of operation or at 24 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
Measured: Until the start of the operation or at 24 hours, average 22 hours
Frequency of satisfactory analgesia
Frequency of patients with satisfactory analgesia i the period from the nerve block until the time of operation or at 20 hours compared between the groups
Measured: Until the start of the operation or at 20 hours, average 18 hours
Time to wish for opioid analgesia
Mean time fra nerve block to wish for opioid analgesia compared between groups
Measured: Until the start of the operation or at 24 hours, average 22 hours
Use of opioid analgesia until 20 hours
Mean use of opioid analgesia until the time of operation or at 20 hours compared between groups
Measured: Until the start of the operation or at 20 hours, average 18 hours
Use of opioid analgesia until 22 hours
Mean use of opioid analgesia until the time of operation or at 22 hours compared between groups
Measured: Until the start of the operation or at 22 hours, average 20 hours
Use of opioid analgesia until 24 hours
Mean use of opioid analgesia until the time of operation or at 24 hours compared between groups
Measured: Until the start of the operation or at 24 hours, average 22 hours
Time to analgesic effect with patient at rest
Mean time from nerve block to verbal pain score ≤3 at rest
Measured: 30 minutes
Time to analgesic effect measured while doing passive leg raise
Mean time from nerve block to verbal pain score ≤5 while doing passive leg raise
Measured: 30 minutes
Frequency of insufficient analgesia
Frequency of patients with hip fracture with insufficient analgesia after femoral nerve block at 30 minutes
Measured: 30 minutes
Frequency of absent analgesia
Frequency of patients with hip fracture with absent analgesia after femoral nerve block at 30 minutes
Measured: 30 minutes
Frequency of patients without sufficient analgesia
Frequency of patients with hip fracture without sufficient analgesia after femoral nerve block at 30 minutes
Measured: 30 minutes
Skin sensation in saphenous area
Frequency of reduced cold sensation in the skin area innervated by the saphenous nerve when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block
Measured: 30 minutes
Skin sensation in area of the anterior cutaneous branches of the femoral nerve
Frequency of reduced cold sensation in the skin area innervated by the anterior cutaneous branches of the femoral nerve when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block
Measured: 30 minutes
Sufficient analgesia Dexamethasone vs. plain
Success rate of sufficient analgesia after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain bupivacaine
Measured: 30 minutes
Nerve visualization
Frequency of possible ultrasound visualization of the femoral nerve
Measured: Just before injection, which is within an expected average of 10 minutes after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Less inclusions than expected with the given criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas F. Bendtsen, MD, Ph.d., Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248870
- Sponsor's protocol ID
- protocol1tdn
- Status last verified
- Mar 2015
- First submitted
- 18 Sep 2014
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33238043
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Duration af a Preoperative Single-shot Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT02248870
- Acronym / sponsor ID
- protocol1tdn
- Conditions
- Hip Fracture
- Keywords
- femoral neck
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Less inclusions than expected with the given criteria
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Sep 2014 (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.
Prolongation of the analgesic effect of a femoral nerve block from the present 15 hours to 24 hours in patients with hip fracture would have a major impact in order to provide better preoperative analgesia for this group.
In other trials concerning other nerves then the femoral nerve the addition of Dexamethasone to the local anesthetics doubled the analgesic duration. No studies has investigated the effect of the addition of Dexamethasone to the femoral nerve block in patients with hip fracture.
The aim of our study is to investigate if more patients with hip fracture experience lasting preoperative analgesia until the time of operation or 20 hours after a femoral nerve block with the addition of Dexamethasone compared to the same nerve block done without Dexamethasone.
Detailed description
Patients with hip fractures are most often old, have multiple comorbidities and suffer severe pain.
Femoral nerve block as a means of preoperative analgesia for these patients has proven effective in multiple trials for the majority of the patients. Still some issues remains to be investigated in order to optimize the preoperative analgesia for this group.
One of the issues that reduces the feasibility of the femoral nerve block is the relatively shorter analgesic duration of the nerve block compared to the often longer time from the hospital admission to the actual operation. From the literature and our own experience the mean analgesic duration of a femoral nerve block approximates 15 hours.
Many studies have shown a prolonged analgesic duration of different nerve blocks when Dexamethasone was added to the local anesthetics. Some studies show a 100 percent increase in duration.
To our knowledge no studies have been published regarding prolongation of the analgesic effect of the femoral nerve block with Dexamethasone, and also none regarding the group of patients with hip fracture.
The clinical impact of a femoral nerve block with an analgesic duration of 20 hours compared to the present 15 hours would be less patients waking up in wards during the night time with pain and a terminated femoral nerve block.
The purpose of this study is to investigate if more patients with hip fracture experience a lasting preoperative analgesic duration of at least 20 hours or until the time of operation after a femoral nerve block with Bupivacaine with adrenaline and the addition of Dexamethasone compared to the same nerve block done with only Bupivacaine with adrenaline.
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 |
|---|---|---|
| Saline | Placebo comparator | Drug: SalineBupivacaine with adrenaline with 2 ml. of Saline added |
| Dexamethasone | Experimental | Drug: DexamethasoneBupivacaine with adrenaline with 2 ml. of Dexamethasone added |
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 (11 listed)
- Hip fracture not confirmed by x-ray
- Weight < 40 kg
- Verbal pain score > 3, 30 minutes after the nerve block
- Verbal pain score > 5 with passive leg raise, 30 minutes after the nerve block
- Patient has previously been included in this trial
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 |
|---|---|---|
| DexamethasoneDexamethasone is added to Bupivacaine with Adrenaline for perineural injection | Drug | Dexamethasone |
| SalineAlso: Solution of sodium chlorideSaline is added as a placebo to Bupivacaine with adrenaline for perineural injection | Drug | Saline |
Primary outcome
Frequency of analgesia at the time of operation or at 20 hours
Time frame: Until the start of the operation or at 20 hours, average 18 hours
Frequency of analgesia at the time of operation or at 20 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
16 secondary outcomes
Frequency of analgesia at the time of operation or at 22 hours
Time frame: Until the start of the operation or at 22 hours, average 20 hours
Frequency of analgesia at the time of operation or at 24 hours
Time frame: Until the start of the operation or at 24 hours, average 22 hours
Frequency of satisfactory analgesia
Time frame: Until the start of the operation or at 20 hours, average 18 hours
Time to wish for opioid analgesia
Time frame: Until the start of the operation or at 24 hours, average 22 hours
Use of opioid analgesia until 20 hours
Time frame: Until the start of the operation or at 20 hours, average 18 hours
Use of opioid analgesia until 22 hours
Time frame: Until the start of the operation or at 22 hours, average 20 hours
Use of opioid analgesia until 24 hours
Time frame: Until the start of the operation or at 24 hours, average 22 hours
Time to analgesic effect with patient at rest
Time frame: 30 minutes
Time to analgesic effect measured while doing passive leg raise
Time frame: 30 minutes
Frequency of insufficient analgesia
Time frame: 30 minutes
Frequency of absent analgesia
Time frame: 30 minutes
Frequency of patients without sufficient analgesia
Time frame: 30 minutes
Skin sensation in saphenous area
Time frame: 30 minutes
Skin sensation in area of the anterior cutaneous branches of the femoral nerve
Time frame: 30 minutes
Sufficient analgesia Dexamethasone vs. plain
Time frame: 30 minutes
Nerve visualization
Time frame: Just before injection, which is within an expected average of 10 minutes after inclusion
Results and safety
The study was stopped early (reason given: Less inclusions than expected with the given criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
- Derived from this study: PubMed 33238043Guay 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.
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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, MD, 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 Dexamethasone and Saline in people with Hip Fracture, 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 11 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: stopped early, as of the sponsor's last update on 14 Sep 2015. 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?
The study was stopped early (reason given: Less inclusions than expected with the given criteria). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of analgesia at the time of operation or at 20 hours (time frame: Until the start of the operation or at 20 hours, average 18 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02248870, which also lists 1 linked publication.
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 14 Sep 2015.