Hip FracturesNCT04705974
MED90 of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain in Spinal Anesthesia Positioning
A study testing Fascia iliaca block, Femoral nerve block and Pericapsular nerve group block (PENG block) in people with Hip Fractures, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
This study aims to determine the minimum effective dose of ropivacaine for peripheral nerve block on posture-evoked pain for spinal anesthesia in elderly patients with hip fracture. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Fascia iliaca block, Femoral nerve block and Pericapsular nerve group block (PENG block)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2022to 15 May 2024
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 - 85 years
- American Society of Anesthesiologists physical statusⅠ- Ⅲ
- Patients will receive hip replacement
Who cannot join
- Patient refusal
- Cognitive impairment(NRS pain score cannot be assessed)
- Peripheral neuropathy
- Mutiple furacture
- skin infection at the site of injection
- allergy to ropivacaine、lidocaine or bupivacaine
- contraindication to spinal anesthesia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Tongji Hospital
Wuhan, Hubei, 430060
Wei Mei, Dr., +86-13006162508, wmei@hust.edu.cn
Yong Liu, Dr., +86-15007124668, hosp1yong@163.com
About this study
Official title: Minimum Effective Dose of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain for Spinal Anesthesia in Patients With Hip Fracture
This study aims to determine the minimum effective dose of ropivacaine for peripheral nerve block on posture-evoked pain for spinal anesthesia in elderly patients with hip fracture. Three types of peripheral nerve block, including fascia iliaca block, femoral nerve block and Pericapsular nerve group block (PENG block) will be assessed.
Read the detailed description
Patients with hip fractures are anticipated to endure sever pain caused by positional changes required for spinal anesthesia. Providing analgesia before positioning not only increases patient comfort but also improves positioning and successful spinal block. Peripheral nerve block is an effective strategy for relieving pain during postures change for spinal anesthesia in patients with hip fractures. Three types of peripheral nerve block, including fascia iliaca block, femoral nerve block and Pericapsular nerve group block (PENG block), has been successfully used for analgesia for spinal anesthesia positioning in patients with hip fractures. However, the minimum effective dose of local anesthetics for these three types of peripheral nerve block is not known. This study aims to determine the minimum effective dose of ropovacaine in the three types of peripheral nerve block using a biased coin design up-and-down sequential method. Successful block is defined as NRS score ≤3 by positional changes for spinal anesthesia, achieved at 20min after the block. MED90 of ropivacaine for fascia iliaca block, femoral nerve block and PENG block be assessed respectively. Patients will receive ultrasound guided peripheral nerve block. The initial dose is chosen as 80 mg on the basis of clinical experience. Subsequently, if a patient has an inadequate block, the ropivacaine dose is increased by 8 mg in the next subject. If a patient has a successful block, the next subject is randomized to receive either a lower dose (with a decrement of 8 mg), with a probability of b = 0.11, or the same dose, with a probability of 1 - b = 0.89. Forty five successful blocks for each type of nerve block will be accomplished. MED90 of each type of nerve block will be calculated by isotonic regression.
- Conditions
- Hip Fractures
- Being tested
- Fascia iliaca block, Femoral nerve block, Pericapsular nerve group block (PENG block)
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia iliaca blockProcedure or surgery
Fascia iliaca block will be performed under ultrasound guidenance.
Femoral nerve blockProcedure or surgery
Femoral nerve block will be performed under ultrasound guidenance.
Pericapsular nerve group block (PENG block)Procedure or surgery
Pericapsular nerve group block (PENG block) will be performed under ultrasound guidenance.
| Study group | Role | What they receive |
|---|---|---|
| Fascia iliaca block | Experimental | ultrasound-guided fascia iliaca block with predetermined dose of 0.4% ropivacaine will be performed. Receives: Procedure: Fascia iliaca block |
| Femoral nerve block | Experimental | ultrasound-guided ultrasound-guided femoral nerve block with predetermined dose of 0.4% ropivacaine will be performed. Receives: Procedure: Femoral nerve block |
| Pericapsular nerve group block (PENG block) | Experimental | ultrasound-guided ultrasound-guided pericapsular nerve group block with predetermined dose of 0.4% ropivacaine will be performed. Receives: Procedure: Pericapsular nerve group block (PENG block) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The minimum effective dose of ropivacaine in three types of nerve block for analgesia for spinal anesthesia positioning in patients with hip fractures
The minimum effective dose of ropivacaine in each type of nerve block is based on 45 patients with satisfactory analgesia during positioning for spinal anesthesia.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start25 Jan 2022
- Primary completion1 May 2024 (estimated)
- Study completion15 May 2024 (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 Huazhong University of Science and TechnologyThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705974
- Sponsor's protocol ID
- MEDNB-HP
- Status last verified
- Jan 2022
- First submitted
- 9 Jan 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimum Effective Dose of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain for Spinal Anesthesia in Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT04705974
- Acronym / sponsor ID
- MEDNB-HP
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 12 Jan 2021 (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.
This study aims to determine the minimum effective dose of ropivacaine for peripheral nerve block on posture-evoked pain for spinal anesthesia in elderly patients with hip fracture. Three types of peripheral nerve block, including fascia iliaca block, femoral nerve block and Pericapsular nerve group block (PENG block) will be assessed.
Detailed description
Patients with hip fractures are anticipated to endure sever pain caused by positional changes required for spinal anesthesia. Providing analgesia before positioning not only increases patient comfort but also improves positioning and successful spinal block. Peripheral nerve block is an effective strategy for relieving pain during postures change for spinal anesthesia in patients with hip fractures. Three types of peripheral nerve block, including fascia iliaca block, femoral nerve block and Pericapsular nerve group block (PENG block), has been successfully used for analgesia for spinal anesthesia positioning in patients with hip fractures. However, the minimum effective dose of local anesthetics for these three types of peripheral nerve block is not known. This study aims to determine the minimum effective dose of ropovacaine in the three types of peripheral nerve block using a biased coin design up-and-down sequential method. Successful block is defined as NRS score ≤3 by positional changes for spinal anesthesia, achieved at 20min after the block. MED90 of ropivacaine for fascia iliaca block, femoral nerve block and PENG block be assessed respectively. Patients will receive ultrasound guided peripheral nerve block. The initial dose is chosen as 80 mg on the basis of clinical experience. Subsequently, if a patient has an inadequate block, the ropivacaine dose is increased by 8 mg in the next subject. If a patient has a successful block, the next subject is randomized to receive either a lower dose (with a decrement of 8 mg), with a probability of b = 0.11, or the same dose, with a probability of 1 - b = 0.89. Forty five successful blocks for each type of nerve block will be accomplished. MED90 of each type of nerve block will be calculated by isotonic regression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fascia iliaca block | Experimental | Procedure: Fascia iliaca blockultrasound-guided fascia iliaca block with predetermined dose of 0.4% ropivacaine will be performed. |
| Femoral nerve block | Experimental | Procedure: Femoral nerve blockultrasound-guided ultrasound-guided femoral nerve block with predetermined dose of 0.4% ropivacaine will be performed. |
| Pericapsular nerve group block (PENG block) | Experimental | Procedure: Pericapsular nerve group block (PENG block)ultrasound-guided ultrasound-guided pericapsular nerve group block with predetermined dose of 0.4% ropivacaine will be performed. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65 - 85 years
- American Society of Anesthesiologists physical statusⅠ- Ⅲ
- Patients will receive hip replacement
Key exclusion criteria (7 listed)
- Patient refusal
- Cognitive impairment(NRS pain score cannot be assessed)
- Peripheral neuropathy
- Mutiple furacture
- skin infection at the 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 |
|---|---|---|
| Fascia iliaca blockFascia iliaca block will be performed under ultrasound guidenance. | Procedure or surgery | Fascia iliaca block |
| Femoral nerve blockFemoral nerve block will be performed under ultrasound guidenance. | Procedure or surgery | Femoral nerve block |
| Pericapsular nerve group block (PENG block)Pericapsular nerve group block (PENG block) will be performed under ultrasound guidenance. | Procedure or surgery | Pericapsular nerve group block (PENG block) |
Primary outcome
The minimum effective dose of ropivacaine in three types of nerve block for analgesia for spinal anesthesia positioning in patients with hip fractures
Time frame: up to 24 months
The minimum effective dose of ropivacaine in each type of nerve block is based on 45 patients with satisfactory analgesia during positioning for spinal anesthesia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: No
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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.
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 block, Femoral nerve block and Pericapsular nerve group block (PENG block) in people with Hip Fractures, run by Huazhong University of Science and Technology at 1 site in China.
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 7 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 9 Feb 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Liu, Dr. (+86-15007124668, hosp1yong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The minimum effective dose of ropivacaine in three types of nerve block for analgesia for spinal anesthesia positioning in patients with hip fractures (time frame: up to 24 months). 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 9 Feb 2022.