Spinal AnesthesiaNCT05987254
Peri-Capsular Nerve Group and Supra Inguinal Fascia Iliaca BLOCK for Analgesia and Ease of Positioning During Neuraxial Anesthesia in Hip Fracture Patients
A study testing suprainguinal fascia iliaca block and pericapsular nerve group block in people with Spinal Anesthesia and Hip Fractures, run by Al-Azhar University at 3 sites in Egypt.
Trial summary
Severe pain associated with fractured hip often results in difficulty during positioning for spinal anesthesia (SA). Among many regional analgesic techniques, the fascia iliaca compartment block (FICB) is popular among anesthesiologists to provide immediate as well as postoperative analgesia in hip fractures. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Spinal Anesthesia, Hip Fractures
- What is being tested?
- suprainguinal fascia iliaca block and pericapsular nerve group block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesEgypt
- Study dates
- 10 Aug 2023to 30 Mar 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years and above with hip fracture with persistent pain and scheduled for surgery under spinal anesthesia (SA)
Who cannot join
- any contraindications to SA or peripheral nerve blocks, history of ischaemic heart disease, patients on opioids for chronic pain and patients with significant cognitive impairment. Patients who had no pain while sitting by themselves (resting pain less than 4 on NRS) for SA without any support were also excluded.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Haney Baumey
Banhā, 13518
Facualty of Pharmacy, Al Azhar University
Cairo, 11765
Neveen Kohaf
Tanta, 11865
About this study
Official title: Comparison Between Peri-Capsular Nerve Group and Supra Inguinal Fascia Iliaca BLOCK for Analgesia and Ease of Positioning During Neuraxial Anesthesia in Hip Fracture Patients: A Randomized Clinical Trial.
Severe pain associated with fractured hip often results in difficulty during positioning for spinal anesthesia (SA). Among many regional analgesic techniques, the fascia iliaca compartment block (FICB) is popular among anesthesiologists to provide immediate as well as postoperative analgesia in hip fractures. Recently, the pericapsular nerve group (PENG) block has been proposed to provide effective analgesia in hip fracture patients. However, comparative studies between PENG and FICB are lacking.
- Conditions
- Spinal Anesthesia, Hip Fractures
- Being tested
- suprainguinal fascia iliaca block, pericapsular nerve group 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.
suprainguinal fascia iliaca blockProcedure or surgery
ultrasound guided suprainguinal fascia iliaca block
pericapsular nerve group blockProcedure or surgery
ultrasound guided pericapsular nerve group block
| Study group | Role | What they receive |
|---|---|---|
| FICB group | Active comparator | received ultrasound guided suprainguinal fascia iliaca block Receives: Procedure: suprainguinal fascia iliaca block |
| PENG group | Active comparator | received ultrasound guided pericapsular nerve group block Receives: Procedure: pericapsular nerve group block |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Measured: 30 minute postoperative
The ease of spinal positioning (EOSP)
The ease of spinal positioning (EOSP) was assessed on the scale of 0-3 (0 = unable to position, 1 = patient had abnormal posturing due to pain and required support for positioning, 2 = mild discomfort but does not require support for positioning, 3 = optimal condition where the patient was able to position himself without pain)
Measured: Thirty minutes after the blocks
Secondary outcomes (1)
amount of tramadol used
number of rescue doses of tramadol will be recorded
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start10 Aug 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
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.
- More trials run by Al-Azhar 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
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987254
- Sponsor's protocol ID
- RC 11-3-2023
- Status last verified
- Jul 2024
- First submitted
- 4 Aug 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be shared upon resealable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Peri-Capsular Nerve Group and Supra Inguinal Fascia Iliaca BLOCK for Analgesia and Ease of Positioning During Neuraxial Anesthesia in Hip Fracture Patients: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05987254
- Acronym / sponsor ID
- RC 11-3-2023
- Conditions
- Spinal Anesthesia, Hip Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 14 Aug 2023 (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.
Severe pain associated with fractured hip often results in difficulty during positioning for spinal anesthesia (SA). Among many regional analgesic techniques, the fascia iliaca compartment block (FICB) is popular among anesthesiologists to provide immediate as well as postoperative analgesia in hip fractures. Recently, the pericapsular nerve group (PENG) block has been proposed to provide effective analgesia in hip fracture patients. However, comparative studies between PENG and FICB are lacking.
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 |
|---|---|---|
| FICB group | Active comparator | Procedure: suprainguinal fascia iliaca blockreceived ultrasound guided suprainguinal fascia iliaca block |
| PENG group | Active comparator | Procedure: pericapsular nerve group blockreceived ultrasound guided pericapsular nerve group block |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 40 years and above with hip fracture with persistent pain and scheduled for surgery under spinal anesthesia (SA)
Key exclusion criteria (1 listed)
- any contraindications to SA or peripheral nerve blocks, history of ischaemic heart disease, patients on opioids for chronic pain and patients with significant cognitive impairment. Patients who had no pain while sitting by themselves (resting pain less than 4 on NRS) for SA without any support were also excluded.
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 |
|---|---|---|
| suprainguinal fascia iliaca blockultrasound guided suprainguinal fascia iliaca block | Procedure or surgery | FICB group |
| pericapsular nerve group blockultrasound guided pericapsular nerve group block | Procedure or surgery | PENG group |
Primary outcome
NRS
Time frame: 30 minute postoperative
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
The ease of spinal positioning (EOSP)
Time frame: Thirty minutes after the blocks
The ease of spinal positioning (EOSP) was assessed on the scale of 0-3 (0 = unable to position, 1 = patient had abnormal posturing due to pain and required support for positioning, 2 = mild discomfort but does not require support for positioning, 3 = optimal condition where the patient was able to position himself without pain)
1 secondary outcome
amount of tramadol used
Time frame: 24 hours postoperatively
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 31 Jul 2024.
- Individual participant dataSharing planned: Yes. data will be shared upon resealable request from the principal investigator
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suprainguinal fascia iliaca block and pericapsular nerve group block in people with Spinal Anesthesia and Hip Fractures, run by Al-Azhar University at 3 sites in Egypt.
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 1 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 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. 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?
NRS (time frame: 30 minute postoperative). 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 31 Jul 2024.