Femur FractureNCT05817916
Comparison of Erector Spina Plane Block and Lumbar Plexus Block in Femoral Fracture Surgery
A study testing ESP block and LP block in people with Femur Fracture and Erector Spinae, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The aim is to clinical trials compare the lumbar plexus block method with the erector spinae plan block method in terms of analgesic efficacy and possible complications. İn patients for femur fracture surgery. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 45 to 95 years
- Conditions the study is for
- Femur Fracture, Erector Spinae, Lumbar Plexus
- What is being tested?
- ESP block and LP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 15 Nov 2023
- 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 45 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proximal femoral surgery
- All patients who can respond to pain assessment questions
Who cannot join
- Regional block contraindications,
- Severe cardiac and respiratory disease,
- Severe coagulopathy,
- Body mass index greater than 35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Erector Spina Plane Block and Lumbar Plexus Block for Postoperative Analgesia in Femoral Fracture Surgery
The aim is to clinical trials compare the lumbar plexus block method with the erector spinae plan block method in terms of analgesic efficacy and possible complications. İn patients for femur fracture surgery. The main questions it aims to answer are: 1. is erector spinae plane block as effective as lumbar plexus block for postoperative analgesia in femur fractures? 2. Is erector spinae plane block effective for reducing opioid consumption compared to lumbar plexus block?
- Conditions
- Femur Fracture, Erector Spinae, Lumbar Plexus, Ultrasound Guide
- Being tested
- ESP block, LP block
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP blockProcedure or surgery
ESP block: ultrasound guided erector spina plane block
LP blockProcedure or surgery
LP block: ultrasound guided lumbar plexus block
| Study group | Role | What they receive |
|---|---|---|
| ESP Block | Active comparator | Not described Receives: Procedure: ESP block |
| LP block | Active comparator | Not described Receives: Procedure: LP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
Opioid consumption will be measured in micrograms.
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start15 Apr 2023
- Primary completion15 Oct 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: The patients in the first group (ESP Group) will be applied ultrasound guided ESP block at the lateral position at the end of the surgery. ESP will be performed with a posterior approach, under ultrasound guidance, by imaging the muscles and the needle. Group 2: At the end of the surgery, patients in the second group (LP Group) will have an appropriate level of LP block with ultrasound guidance and, if necessary, using a neurostimulator.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817916
- Sponsor's protocol ID
- ali eman 002
- Status last verified
- May 2024
- First submitted
- 23 Jan 2023
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Badiola I, Liu J, Huang S, Kelly JD 4th, Elkassabany N. A comparison of the fascia iliaca block to the lumbar plexus block in providing analgesia following arthroscopic hip surgery: A randomized controlled clinical trial. J Clin Anesth. 2018 Sep;49:26-29. doi: 10.1016/j.jclinane.2018.05.012. Epub 2018 Jun 1.
PubMed 29860224Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
PubMed 29522966
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spina Plane Block and Lumbar Plexus Block for Postoperative Analgesia in Femoral Fracture Surgery
- ClinicalTrials.gov ID
- NCT05817916
- Acronym / sponsor ID
- ali eman 002
- Conditions
- Femur Fracture, Erector Spinae, Lumbar Plexus, Ultrasound Guide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 18 Apr 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.
The aim is to clinical trials compare the lumbar plexus block method with the erector spinae plan block method in terms of analgesic efficacy and possible complications. İn patients for femur fracture surgery. The main questions it aims to answer are: 1. is erector spinae plane block as effective as lumbar plexus block for postoperative analgesia in femur fractures? 2. Is erector spinae plane block effective for reducing opioid consumption compared to lumbar plexus block?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: The patients in the first group (ESP Group) will be applied ultrasound guided ESP block at the lateral position at the end of the surgery. ESP will be performed with a posterior approach, under ultrasound guidance, by imaging the muscles and the needle. Group 2: At the end of the surgery, patients in the second group (LP Group) will have an appropriate level of LP block with ultrasound guidance and, if necessary, using a neurostimulator.
| Arm | Type | Receives |
|---|---|---|
| ESP Block | Active comparator | Procedure: ESP block |
| LP block | Active comparator | Procedure: LP block |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Proximal femoral surgery
- All patients who can respond to pain assessment questions
Key exclusion criteria (4 listed)
- Regional block contraindications,
- Severe cardiac and respiratory disease,
- Severe coagulopathy,
- Body mass index greater than 35
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 |
|---|---|---|
| ESP blockESP block: ultrasound guided erector spina plane block | Procedure or surgery | ESP Block |
| LP blockLP block: ultrasound guided lumbar plexus block | Procedure or surgery | LP block |
Primary outcome
Postoperative opioid consumption
Time frame: postoperative 24 hours
Opioid consumption will be measured in micrograms.
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 8 May 2024.
- Results publication: PubMed 29860224Badiola I, Liu J, Huang S, Kelly JD 4th, Elkassabany N. A comparison of the fascia iliaca block to the lumbar plexus block in providing analgesia following arthroscopic hip surgery: A randomized controlled clinical trial. J Clin Anesth. 2018 Sep;49:26-29. doi: 10.1016/j.jclinane.2018.05.012. Epub 2018 Jun 1.
- Results publication: PubMed 29522966Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESP block and LP block in people with Femur Fracture and Erector Spinae, run by Sakarya University 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 2 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 8 May 2024. 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?
Postoperative opioid consumption (time frame: postoperative 24 hours). 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 NCT05817916, which also lists 2 linked publications.
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 8 May 2024.