Hip FracturesNCT03670290
Clinical Outcomes of Analgesia Methods in Patients With Hip Fracture
An observational study of Hip Fractures, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to determine of clinical outcomes of analgesia methods. The primary outcomes are opioid consumption, static and dynamic visual analog scale (VAS) scores. Secondary outcomes are occurrence of side effects. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Fascia iliaca compartment catheter and epidural catheter
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2018to 15 Oct 2019
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study will be performed from 01/12/2018 to 01/06/2019. It is estimated to each group includes 40 patient.
Who may be able to join
- Patients without communication problems (delirium, hearing loss, language problems etc.)
- Patients who do not use regular analgesic medication for any chronic disease
- Patients without any neurological deficit at the lower extremity
- Patients without renal or hepatic dysfunction
- Patients without bleeding diathesis
- Patients with isolated femur fractures
Who cannot join
- Patients with communication problems
- Patients who use regular analgesic medication for any chronic disease
- Patients with neurological deficits in the lower extremity
- Patients with renal or hepatic dysfunction
- Patients with bleeding diathesis
- Patients with multiple trauma
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to determine of clinical outcomes of analgesia methods. The primary outcomes are opioid consumption, static and dynamic visual analog scale (VAS) scores. Secondary outcomes are occurrence of side effects.
Read the detailed description
Hip fracture is one of the most serious consequences of falls in the elderly, with a mortality of 10% at one month and 30% at one year. Factors of associated with increased morbidity and mortality have been researched to prevent complications.
Pain has been associated with delirium and depression in hip fracture patients. Besides, narcotic drugs are also associated with some side effects such as delirium, postoperative nausea and vomiting (PONV ), cardiovascular and respiratory depression. These clinical problems are especially important in the elderly population.
Fascia iliaca compartment block (FICB) is one of the methods applied for postoperative analgesia, which is applied under the inguinal ligament and distributes between the femoral nerve and lateral femoral cutaneous nerve block by volumetric effect. Recently, studies have been published on hip fracture patients using pop up technique in emergency services. Although many studies have shown that FICB is effective in perioperative analgesia, the effects of this method on complications and mortality rate have not yet been investigated.
The primary objective is to compare morphine consumption and VAS scores in patients with hip fracture who treated with epidural catheter, fascia iliaca compartment catheter or patient controlled analgesia.
The secondary objective is to determine complications. The investigators hypothesize that FICB catheter will provide good pain control same as epidural catheter, and will decrease complications such as delirium and pain with less mortality rate.
Patients with pain in the hip fracture, will be evaluated after admission to the hospital and analgesic treatment will be applied to patients with Visual Analog Pain Scale (VAS) score 3 and above.
Patients will be divided into three groups; Group I will include patients with treated FICB catheter, Group II will include patients with treated patient controlled analgesia, Group III will include patients with treated epidural catheter,
Catheters will be placed with US visualization in Group I. A hyperechoic needle will be used (18 G 80 mm) for inserting catheter in Group I and III.
Group I will receive 30 ml of Bupivacaine 0.25% solution through the fascia iliaca compartment catheter.
Group II will receive, morphine 0.1 mg/ml via patient controlled analgesia pump. every pump will be set 1 mg dose morphine per use and 15 min lockout time.
Group III will receive 10 ml of Bupivacaine 0.25% solution through the epidural catheter.
- Conditions
- Hip Fractures
- Being tested
- Fascia iliaca compartment catheter, epidural catheter, patient controlled analgesia
- Keywords
- hip fracture, fascia iliaca compartment catheter, epidural catheter, delirium, postoperative complications
- Medical subject headings
- Hip Fractures, Delirium, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia iliaca compartment catheterProcedure or surgery
Patient will evaluate and if VAS score >3, catheter will be inserted and 30 ml bupivacaine 0.25% will be applied after admission. Dose will be repeated VAS>3 or patient enounce pain.
epidural catheterProcedure or surgery
Patient will evaluate and if VAS score >3, catheter will be inserted and 10 ml bupivacaine 0.25% will be applied after admission. Dose will be repeated VAS>3 or patient enounce pain.
patient controlled analgesiaProcedure or surgery
Patient will evaluate and if VAS score >3, patient controlled analgesia pump will be set 1mg morphine/15 min lockout.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group I will receive 30 ml of Bupivacaine 0.25% solution through the fascia iliaca compartment catheter. Catheter will be inserted with US. Receives: Procedure: Fascia iliaca compartment catheter | |
| Group 2 | Group II will receive, morphine 0.1 mg/ml via patient controlled analgesia pump. every pump will be set 1 mg dose morphine per use and 15 min lockout time. Receives: Procedure: patient controlled analgesia | |
| Group 3 | Group III will receive 10 ml of Bupivacaine 0.25% solution through the epidural catheter. Receives: Procedure: epidural catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
All perioperative morphine consumption will be recoreded every 6 hours.
Measured: From the beginning of treatment to discharge (Totally 5 days)
Visual analogue score
Mean visual analogue scores will be compared for 3 groups. VAS score will measured from 0 to 10. Higher values represent worse outcome.
Measured: From admission to second postoperative day. (Totally 5 days)
Secondary outcomes (1)
incidence of postoperative complications in 30 day post-surgery.
Patients will be monitored and every serious complication related with surgery including respiratory failure, hypotension, delirium, thromboembolism, nausea and vomiting will be recorded. These events will be measured as percentage (%)
Measured: From end of surgery to Day 30 after surgery (totally 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start15 Dec 2018
- Primary completion31 Aug 2019
- Study completion15 Oct 2019
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 Mersin UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Azizoğlu, Mersin University
- Investigators
- Mustafa Azizoglu, Study director, Mersin University, Anesthesia and Reanimation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670290
- Sponsor's protocol ID
- MEUANEST001
- Status last verified
- Feb 2020
- First submitted
- 6 Sep 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Every entered data could share to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Analgesia Methods in Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT03670290
- Acronym / sponsor ID
- MEUANEST001
- Conditions
- Hip Fractures
- Keywords
- hip fracture, fascia iliaca compartment catheter, epidural catheter, delirium, postoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 13 Sep 2018 (actual)
- 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.
The goal of this study is to determine of clinical outcomes of analgesia methods. The primary outcomes are opioid consumption, static and dynamic visual analog scale (VAS) scores. Secondary outcomes are occurrence of side effects.
Detailed description
Hip fracture is one of the most serious consequences of falls in the elderly, with a mortality of 10% at one month and 30% at one year. Factors of associated with increased morbidity and mortality have been researched to prevent complications.
Pain has been associated with delirium and depression in hip fracture patients. Besides, narcotic drugs are also associated with some side effects such as delirium, postoperative nausea and vomiting (PONV ), cardiovascular and respiratory depression. These clinical problems are especially important in the elderly population.
Fascia iliaca compartment block (FICB) is one of the methods applied for postoperative analgesia, which is applied under the inguinal ligament and distributes between the femoral nerve and lateral femoral cutaneous nerve block by volumetric effect. Recently, studies have been published on hip fracture patients using pop up technique in emergency services. Although many studies have shown that FICB is effective in perioperative analgesia, the effects of this method on complications and mortality rate have not yet been investigated.
The primary objective is to compare morphine consumption and VAS scores in patients with hip fracture who treated with epidural catheter, fascia iliaca compartment catheter or patient controlled analgesia.
The secondary objective is to determine complications. The investigators hypothesize that FICB catheter will provide good pain control same as epidural catheter, and will decrease complications such as delirium and pain with less mortality rate.
Patients with pain in the hip fracture, will be evaluated after admission to the hospital and analgesic treatment will be applied to patients with Visual Analog Pain Scale (VAS) score 3 and above.
Patients will be divided into three groups; Group I will include patients with treated FICB catheter, Group II will include patients with treated patient controlled analgesia, Group III will include patients with treated epidural catheter,
Catheters will be placed with US visualization in Group I. A hyperechoic needle will be used (18 G 80 mm) for inserting catheter in Group I and III.
Group I will receive 30 ml of Bupivacaine 0.25% solution through the fascia iliaca compartment catheter.
Group II will receive, morphine 0.1 mg/ml via patient controlled analgesia pump. every pump will be set 1 mg dose morphine per use and 15 min lockout time.
Group III will receive 10 ml of Bupivacaine 0.25% solution through the epidural catheter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Fascia iliaca compartment catheterGroup I will receive 30 ml of Bupivacaine 0.25% solution through the fascia iliaca compartment catheter. Catheter will be inserted with US. |
| Group 2 | – | Procedure: patient controlled analgesiaGroup II will receive, morphine 0.1 mg/ml via patient controlled analgesia pump. every pump will be set 1 mg dose morphine per use and 15 min lockout time. |
| Group 3 | – | Procedure: epidural catheterGroup III will receive 10 ml of Bupivacaine 0.25% solution through the epidural catheter. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study will be performed from 01/12/2018 to 01/06/2019. It is estimated to each group includes 40 patient.
Key inclusion criteria (6 listed)
- Patients without communication problems (delirium, hearing loss, language problems etc.)
- Patients who do not use regular analgesic medication for any chronic disease
- Patients without any neurological deficit at the lower extremity
- Patients without renal or hepatic dysfunction
- Patients without bleeding diathesis
Key exclusion criteria (6 listed)
- Patients with communication problems
- Patients who use regular analgesic medication for any chronic disease
- Patients with neurological deficits in the lower extremity
- Patients with renal or hepatic dysfunction
- Patients with bleeding diathesis
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 |
|---|---|---|
| Fascia iliaca compartment catheterPatient will evaluate and if VAS score >3, catheter will be inserted and 30 ml bupivacaine 0.25% will be applied after admission. Dose will be repeated VAS>3 or patient enounce pain. | Procedure or surgery | Group 1 |
| epidural catheterPatient will evaluate and if VAS score >3, catheter will be inserted and 10 ml bupivacaine 0.25% will be applied after admission. Dose will be repeated VAS>3 or patient enounce pain. | Procedure or surgery | Group 3 |
| patient controlled analgesiaPatient will evaluate and if VAS score >3, patient controlled analgesia pump will be set 1mg morphine/15 min lockout. | Procedure or surgery | Group 2 |
Primary outcome
Morphine consumption
Time frame: From the beginning of treatment to discharge (Totally 5 days)
All perioperative morphine consumption will be recoreded every 6 hours.
Visual analogue score
Time frame: From admission to second postoperative day. (Totally 5 days)
Mean visual analogue scores will be compared for 3 groups. VAS score will measured from 0 to 10. Higher values represent worse outcome.
1 secondary outcome
incidence of postoperative complications in 30 day post-surgery.
Time frame: From end of surgery to Day 30 after surgery (totally 30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: Yes. Every entered data could share to other researchers
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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.
Mustafa Azizoglu study director
Mersin University, Anesthesia and Reanimation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by Mersin University at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 25 Feb 2020. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Morphine consumption (time frame: From the beginning of treatment to discharge (Totally 5 days)). The study lists 2 primary outcomes in all. 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 25 Feb 2020.