Chronic Hip PainNCT02479828
Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients
A study testing Fascia iliaca compartment block, Ropivacaine and ultrasound in people with Chronic Hip Pain, run by Asklepieion Voulas General Hospital at 1 site in Greece.
Trial summary
This study evaluates the effect of fascia iliaca compartment block (FICB) in the management of acute post -surgical pain in hip fracture patients and in the appearance of chronic post -surgical hip pain, by means of von Korff Graded Chronic Pain Scale -modified for hip pain in Greek. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Hip Pain
- What is being tested?
- Fascia iliaca compartment block, Ropivacaine and ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2015to Jan 2018
- Phase
- Interventional
- 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
Who may be able to join
- ASA I-III (American Society of Anesthesiologists classification)
- intertrochanteric fractures
- fractures of femoral neck
Who cannot join
- existing pain in hip Joint to be operated
- cognitive or mental disorder
- administration of analgesic drugs prior surgery
- contraindications of spinal anesthesia
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients
This study evaluates the effect of fascia iliaca compartment block (FICB) in the management of acute post -surgical pain in hip fracture patients and in the appearance of chronic post -surgical hip pain, by means of von Korff Graded Chronic Pain Scale -modified for hip pain in Greek.
Half of the patients will not receive fascia iliaca compartment block.
- Conditions
- Chronic Hip Pain
- Being tested
- Fascia iliaca compartment block, Ropivacaine, ultrasound, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia iliaca compartment blockDrug
40 ml ropivacaine 0,5% injected under fascia iliaca using ultrasound
RopivacaineDrug
ultrasoundDevice
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Fascia iliaca compartment block (FICB) | Active comparator | Under ultrasound guidance performing fascia iliaca compartment block, in which 40 ml ropivacaine 0,5% are injected under the fascia iliaca. Receives: Drug: Fascia iliaca compartment block; Drug: Ropivacaine; Device: ultrasound |
| Placebo (not FICB) | Placebo comparator | Half of the patients will not receive FICB Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute postsurgical pain after hip fracture surgery
Acute pain will be evaluated using the Numeric Rating Scale- NRS (0=no pain, 10= Extremely strong pain) at rest and in motion.
Measured: 48 hours
Chronic postsurgical pain after hip fracture surgery
3 and 6 months after surgery the patient or patient's relative will be asked on telephone to complete Von Korff Graded Chronic scale modified for hip pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2018
- Study completionJan 2018
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 Chronic Hip PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepieion Voulas General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maria Diakomi, Asklepieion Voulas General Hospital
- Investigators
- MARIA DIAKOMI, Principal investigator, Asklepieion General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479828
- Sponsor's protocol ID
- 7533
- Status last verified
- Mar 2019
- First submitted
- 10 Jun 2015
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
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 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT02479828
- Acronym / sponsor ID
- 7533
- Conditions
- Chronic Hip Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Asklepieion Voulas General HospitalOther government
- Study start
- Jun 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 24 Jun 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.
This study evaluates the effect of fascia iliaca compartment block (FICB) in the management of acute post -surgical pain in hip fracture patients and in the appearance of chronic post -surgical hip pain, by means of von Korff Graded Chronic Pain Scale -modified for hip pain in Greek.
Half of the patients will not receive fascia iliaca compartment block.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascia iliaca compartment block (FICB) | Active comparator | Drug: Fascia iliaca compartment block, Drug: Ropivacaine, Device: ultrasoundUnder ultrasound guidance performing fascia iliaca compartment block, in which 40 ml ropivacaine 0,5% are injected under the fascia iliaca. |
| Placebo (not FICB) | Placebo comparator | Drug: PlaceboHalf of the patients will not receive FICB |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III (American Society of Anesthesiologists classification)
- intertrochanteric fractures
- fractures of femoral neck
Key exclusion criteria (5 listed)
- existing pain in hip Joint to be operated
- cognitive or mental disorder
- administration of analgesic drugs prior surgery
- contraindications of spinal anesthesia
- refusal to participate in the study
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 block40 ml ropivacaine 0,5% injected under fascia iliaca using ultrasound | Drug | Fascia iliaca compartment block (FICB) |
| Ropivacaine | Drug | Fascia iliaca compartment block (FICB) |
| ultrasound | Device | Fascia iliaca compartment block (FICB) |
| Placebo | Drug | Placebo (not FICB) |
Primary outcome
Acute postsurgical pain after hip fracture surgery
Time frame: 48 hours
Acute pain will be evaluated using the Numeric Rating Scale- NRS (0=no pain, 10= Extremely strong pain) at rest and in motion.
Chronic postsurgical pain after hip fracture surgery
Time frame: 6 months
3 and 6 months after surgery the patient or patient's relative will be asked on telephone to complete Von Korff Graded Chronic scale modified for hip pain
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 12 Mar 2019.
- 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.
MARIA DIAKOMI principal investigator
Asklepieion General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascia iliaca compartment block, Ropivacaine and ultrasound in people with Chronic Hip Pain, run by Asklepieion Voulas General Hospital at 1 site in Greece.
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 3 inclusion and 5 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 12 Mar 2019. 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 Greece. 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.
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?
Acute postsurgical pain after hip fracture surgery (time frame: 48 hours). 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?
On the ClinicalTrials.gov record for NCT02479828, 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 12 Mar 2019.