Hip FractureNCT02330302
Single Shot Fascia Iliaca Block vs Femoral Nerve Block for Analgesia for Surgical Fixation of Hip Fractures
A study testing Ropivacaine in people with Hip Fracture, run by Changi General Hospital at 1 site in Singapore.
Trial summary
Hip fractures are common in our elderly population and is associated with pain before and after surgery. The current pain management for patients who have undergone surgery for hip fractures include a combination of oral painkillers, opioids (eg morphine) and regional anaesthesia techniques, which involves the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2014to Aug 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled for surgical fixation of hip fracture
- Patients with isolated inter-trochantric fracture
- American Society of Anesthesiologists (ASA) physical status 1 to 3
- Patients who are able to give their own consent
Who cannot join
- Patients unable to give consent or inability to communicate/ cooperate
- Patients with regular consumption of strong opioids (morphine, oxycodone) or steroids
- Patients with allergy to local anaesthetics or any drugs included in the study
- Patients with contraindications to spinal anaesthesia such as coagulation disorders/ thrombocytopenia and local infection at site of injection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Single Shot Fascia Iliaca Block With Femoral Nerve Block for Analgesia Following Surgical Fixation of Hip Fractures
Hip fractures are common in our elderly population and is associated with pain before and after surgery. The current pain management for patients who have undergone surgery for hip fractures include a combination of oral painkillers, opioids (eg morphine) and regional anaesthesia techniques, which involves the injection of local anaesthetic drugs near nerves supplying the hip joint to numb the operation site. As opioids have many side effects, especially in the elderly patients, regional anaesthesia techniques can help to reduce the use of opioids and the related side effects. This may enhance their recovery and length of hospital stay
- Conditions
- Hip Fracture
- Being tested
- Ropivacaine
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called naropin
Ultrasound-guided femoral nerve block with Ropivacaine 0.5% 30mls
RopivacaineDrug
Also called naropin
Ultrasound-guided suprainguinal approach to fascia iliaca block with Ropivacaine 0.5% 30mls
| Study group | Role | What they receive |
|---|---|---|
| Femoral nerve block | Active comparator | Procedure: Ultrasound-guided femoral nerve block Drug: Ropivacaine 0.5% 30mls Receives: Drug: Ropivacaine |
| Fascia Iliaca block | Active comparator | Procedure: Ultrasound-guided suprainguinal approach to fascia iliaca block Drug: Ropivacaine 0.5% 30mls Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
resting and dynamic pain scores are obtained pre-intervention, 30mins post intervention (and on positioning for spinal anaesthesia), 1 hr post-operatively and at 24hrs post intervention
Measured: up to 24 hours
Secondary outcomes (1)
opioid requirement/consumption
need for additional opioids during first 24hrs following intervention record of any opioid related side effects will be kept as well
Measured: for first 24 hrs (including intra operatively) following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionMar 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yean Chin Lim, MBBS, MMed, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330302
- Sponsor's protocol ID
- 2014/453/D
- Status last verified
- Jan 2018
- First submitted
- 31 Dec 2014
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Single Shot Fascia Iliaca Block With Femoral Nerve Block for Analgesia Following Surgical Fixation of Hip Fractures
- ClinicalTrials.gov ID
- NCT02330302
- Acronym / sponsor ID
- 2014/453/D
- Conditions
- Hip Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Jan 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.
Hip fractures are common in our elderly population and is associated with pain before and after surgery. The current pain management for patients who have undergone surgery for hip fractures include a combination of oral painkillers, opioids (eg morphine) and regional anaesthesia techniques, which involves the injection of local anaesthetic drugs near nerves supplying the hip joint to numb the operation site. As opioids have many side effects, especially in the elderly patients, regional anaesthesia techniques can help to reduce the use of opioids and the related side effects. This may enhance their recovery and length of hospital stay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral nerve block | Active comparator | Drug: RopivacaineProcedure: Ultrasound-guided femoral nerve block Drug: Ropivacaine 0.5% 30mls |
| Fascia Iliaca block | Active comparator | Drug: RopivacaineProcedure: Ultrasound-guided suprainguinal approach to fascia iliaca block Drug: Ropivacaine 0.5% 30mls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for surgical fixation of hip fracture
- Patients with isolated inter-trochantric fracture
- American Society of Anesthesiologists (ASA) physical status 1 to 3
- Patients who are able to give their own consent
Key exclusion criteria (4 listed)
- Patients unable to give consent or inability to communicate/ cooperate
- Patients with regular consumption of strong opioids (morphine, oxycodone) or steroids
- Patients with allergy to local anaesthetics or any drugs included in the study
- Patients with contraindications to spinal anaesthesia such as coagulation disorders/ thrombocytopenia and local infection at site of injection
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 |
|---|---|---|
| RopivacaineAlso: naropinUltrasound-guided femoral nerve block with Ropivacaine 0.5% 30mls | Drug | Femoral nerve block |
| RopivacaineAlso: naropinUltrasound-guided suprainguinal approach to fascia iliaca block with Ropivacaine 0.5% 30mls | Drug | Fascia Iliaca block |
Primary outcome
Pain scores
Time frame: up to 24 hours
resting and dynamic pain scores are obtained pre-intervention, 30mins post intervention (and on positioning for spinal anaesthesia), 1 hr post-operatively and at 24hrs post intervention
1 secondary outcome
opioid requirement/consumption
Time frame: for first 24 hrs (including intra operatively) following intervention
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 Jan 2018.
Related trials for Hip Fracture
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.
Yean Chin Lim, MBBS, MMed principal investigator
Changi 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 Ropivacaine in people with Hip Fracture, run by Changi General Hospital at 1 site in Singapore.
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 4 inclusion and 4 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 Jan 2018. 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 Singapore. 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?
Pain scores (time frame: up to 24 hours). 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 Jan 2018.