Spinal AnesthesiaNCT05444803
Femoral Nerve Block vs Peri-capsular Nerve Group Block for Hip Fracture Analgesia
A study testing femoral nerve block and peri-capsular nerve group block in people with Spinal Anesthesia and Analgesia, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is to compare the analgesic efficacy of femoral nerve block and peri-capsular nerve group block administered before spinal anesthesia for positioning to spinal anaesthesia in patients undergoing surgery for hip fracture and to evaluate the efficacy for postoperative analgesia Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spinal Anesthesia, Analgesia, Hip Fractures
- What is being tested?
- femoral nerve block and peri-capsular nerve group block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jul 2022to 19 Dec 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with hip fracture scheduled for surgery under spinal anesthesia.
Who cannot join
- hemorrhagic diathesis,
- peripheral neuropathy,
- allergy to local anesthetics,
- mental disorders,
- use of analgesics for 8 h before the performance of spinal block
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya
About this study
Official title: Comparison of Femoral Nerve Block Versus Peri-capsular Nerve Group Block for Analgesia During Positioning for Spinal Anesthesia in Patients With Hip Fracture
The purpose of the study is to compare the analgesic efficacy of femoral nerve block and peri-capsular nerve group block administered before spinal anesthesia for positioning to spinal anaesthesia in patients undergoing surgery for hip fracture and to evaluate the efficacy for postoperative analgesia
Read the detailed description
Spinal anesthesia is commonly used in patients undergoing hip fracture surgery. However the procedure of patient positioning to perform a spinal block is painful and may require the administration of IV analgesics or some regional anesthesia techniques such as femoral nerve block, fascia-iliaca compartment block, peri-capsular nerve group block. At the study, the investigators aimed to compare analgesic efficacy of femoral nerve block and peri-capsular nerve group block administered before spinal anesthesia for positioning to spinal anaesthesia in patients undergoing surgery for hip fracture and to evaluate the efficacy for postoperative analgesia.
- Conditions
- Spinal Anesthesia, Analgesia, Hip Fractures
- Being tested
- femoral nerve block, peri-capsular nerve group block
- Medical subject headings
- Agnosia, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femoral nerve blockOther
Patients will be performed a femoral nerve block using bupivacaine thirty minutes before the performing of spinal block.
peri-capsular nerve group blockOther
Patients will be performed a peri-capsular nerve group block using bupivacaine thirty minutes before the performing of spinal block.
| Study group | Role | What they receive |
|---|---|---|
| Femoral nerve block group | Other | Thirty minutes before the placement of spinal block, patients will be receive a femoral nerve block with Bupivacaine. Receives: Other: femoral nerve block |
| Peri-capsular nerve group block group | Other | Thirty minutes before the placement of spinal block, patients will be receive a peri-capsular nerve group block with Bupivacaine. Receives: Other: peri-capsular nerve group block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pain scores assessed by Numerical rating Score Scale during positioning for spinal anesthesia
Pain scores will be assessed by Numerical Rating Scale (NRS) scores (from 0=no pain to 10=maximum possible pain).
Measured: 30 minutes
Secondary outcomes (4)
Rate of pain scores at rest
Pain scores will be assessed by Numerical Rating Scale (NRS) scores from 0 (no pain) to 10 (maximum possible pain) at rest before and 30 min after the block performance.
Measured: 30 min
Rate of pain scores on passive limb lifting
Pain scores will be assessed by Numerical Rating Scale (NRS) scores from 0 (no pain) to 10 (maximum possible pain) on passive limb lifting before and 30 min after the block performance.
Measured: 30 min
rate of postoperative pain scores
Pain scores will be assessed by Numerical Rating Scale (NRS) scores from 0 (no pain) to 10 (maximum possible pain).at 6, 12, 24 hours postoperatively.
Measured: 24 hours
Amount of postoperative analgesic consumption
Postoperative analgesic consumption will be recorded for postoperative 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start6 Jul 2022
- Primary completion7 Nov 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Safa Eroglu, M.D., Principal investigator, Antalya Traning and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444803
- Sponsor's protocol ID
- safa1
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Femoral Nerve Block Versus Peri-capsular Nerve Group Block for Analgesia During Positioning for Spinal Anesthesia in Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT05444803
- Acronym / sponsor ID
- safa1
- Conditions
- Spinal Anesthesia, Analgesia, Hip Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 6 Jul 2022 (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 purpose of the study is to compare the analgesic efficacy of femoral nerve block and peri-capsular nerve group block administered before spinal anesthesia for positioning to spinal anaesthesia in patients undergoing surgery for hip fracture and to evaluate the efficacy for postoperative analgesia
Detailed description
Spinal anesthesia is commonly used in patients undergoing hip fracture surgery. However the procedure of patient positioning to perform a spinal block is painful and may require the administration of IV analgesics or some regional anesthesia techniques such as femoral nerve block, fascia-iliaca compartment block, peri-capsular nerve group block. At the study, the investigators aimed to compare analgesic efficacy of femoral nerve block and peri-capsular nerve group block administered before spinal anesthesia for positioning to spinal anaesthesia in patients undergoing surgery for hip fracture and to evaluate the efficacy for postoperative analgesia.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral nerve block group | Other | Other: femoral nerve blockThirty minutes before the placement of spinal block, patients will be receive a femoral nerve block with Bupivacaine. |
| Peri-capsular nerve group block group | Other | Other: peri-capsular nerve group blockThirty minutes before the placement of spinal block, patients will be receive a peri-capsular nerve group block with Bupivacaine. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with hip fracture scheduled for surgery under spinal anesthesia.
Key exclusion criteria (5 listed)
- hemorrhagic diathesis,
- peripheral neuropathy,
- allergy to local anesthetics,
- mental disorders,
- use of analgesics for 8 h before the performance of spinal block
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 |
|---|---|---|
| femoral nerve blockPatients will be performed a femoral nerve block using bupivacaine thirty minutes before the performing of spinal block. | Other | Femoral nerve block group |
| peri-capsular nerve group blockPatients will be performed a peri-capsular nerve group block using bupivacaine thirty minutes before the performing of spinal block. | Other | Peri-capsular nerve group block group |
Primary outcome
Rate of pain scores assessed by Numerical rating Score Scale during positioning for spinal anesthesia
Time frame: 30 minutes
Pain scores will be assessed by Numerical Rating Scale (NRS) scores (from 0=no pain to 10=maximum possible pain).
4 secondary outcomes
Rate of pain scores at rest
Time frame: 30 min
Rate of pain scores on passive limb lifting
Time frame: 30 min
rate of postoperative pain scores
Time frame: 24 hours
Amount of postoperative analgesic consumption
Time frame: 24 hours
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 13 Mar 2023.
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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.
Safa Eroglu, M.D. principal investigator
Antalya Traning and Research 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 femoral nerve block and peri-capsular nerve group block in people with Spinal Anesthesia and Analgesia, run by Antalya Training and Research Hospital 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 1 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 13 Mar 2023. 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?
Rate of pain scores assessed by Numerical rating Score Scale during positioning for spinal anesthesia (time frame: 30 minutes). 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 13 Mar 2023.