Hip FracturesNCT06721052
Retrospective Evaluation of Efficacy of Meta-PENG Block
An observational study of Hip Fractures and Hip Injuries, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The components of the lumbar plexus and capture the articular branches of hip capsule may be effectively blocked by administering a relatively high volume of local anesthetic deep to the iliacus muscle at the level of the anterior inferior iliac spine. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hip Fractures, Hip Injuries
- What is being tested?
- meta-Peng block and Postoperative analgesia management
- Type of treatment
- Injection or infusion
- How many people
- 7 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2024to 12 Sep 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients who underwent hip fracture surgery due to fracture or another reason
Who may be able to join
- ASA-1, ASA-2 and ASA-3 patients who underwent hip surgery under spinal or general anesthesia
Who cannot join
- Anticoagulant drug use Known allergy to the medications to be used Infection in the area where the needle will be inserted Missing data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
About this study
Official title: Retrospective Evaluation of Ultrasound-guided Deep Iliacus Plane Block / Meta-PENG: Another Novel Fascial Plane Block
The components of the lumbar plexus and capture the articular branches of hip capsule may be effectively blocked by administering a relatively high volume of local anesthetic deep to the iliacus muscle at the level of the anterior inferior iliac spine. We can provide both the blockade of the pericapsular nerve group supplying the hip capsule and the cutaneous blockade. Here, we aimed to present our novel technique we named 'deep iliacus plane block (DIPB)'.
Read the detailed description
Many regional anesthesia techniques are used in hip surgeries for various goals, such as optimizing neuraxial positioning and relieving pain in the perioperative period, and have been the subject of clinical researches in the last few decades.
The lumbar plexus is important in administering anesthesia and analgesia during hip and knee surgeries. Comprising the femoral nerve (FN), lateral femoral cutaneous nerve (LFCN), and obturator nerve, it collaborates with the sacral plexus to ensure comprehensive innervation of the lower limb.
We hypothesized that by administering a relatively high volume of local anesthetic deep to the iliacus muscle at the level of the anterior inferior iliac spine (AIIS), we could effectively block the lumbar plexus components and capture the hip capsule's articular branches. We can ensure both the blockade of the pericapsular nerve group supplying the hip capsule and the cutaneous blockade. Here, we aimed to present our cadaveric evaluation and retrospective evaluation of patients underwent meta-PENG block, which we consider the proof-of-concept for our hypothesis of the technique we named 'deep iliacus plane block (DIPB)'.
- Conditions
- Hip Fractures, Hip Injuries
- Being tested
- meta-Peng block, Postoperative analgesia management
- Medical subject headings
- Hip Fractures, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meta-Peng blockDrug
The convex transducer was positioned obliquely in a superolateral to inferomedial direction just above the femoral crest. Anatomical structures including AIIS, iliopubic eminence, sartorius muscle, iliopsoas muscle, psoas tendon, artery, vein, and iliac fascia were identified sono-anatomically. The AIIS was centered in the transducer image. To determine the insertion point of the rectus femoris tendon (RFT) on the AIIS, the transducer was rotated sagittally, and the level where the RFT ends cephalically was identified. After identifying the target, the transducer was obliquated again to visualize the IPE. The 22G x 100 mm block needle was advanced in-plane from lateral to inferomedial towards the potential space between the IPM and AIIS. After confirming the target plane with a few mL of saline, 30-40 mL of 0.25% bupivacain was applied to the area. The spread of injectate was observed beneath the IPM, below the psoas tendon, and around the iliacus muscle within the iliac fascia.
Postoperative analgesia managementDrug
We ordered 400 mg intravenous ibuprofen for the patients every 8 hours during the postoperative period. We planned to perform 100 mg tramadol as a rescue analgesic if the patient's NRS score was above 4. We observed the patients for 24 hours in the postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| Group meta-PENG block | We performed meta-PENG block in patients who underwent hip surgery under spinal or general anesthesia Receives: Drug: meta-Peng block; Drug: Postoperative analgesia management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores (Numerical rating scale-NRS)
Comparison of NRS before block, after block, and during position for surgery
Measured: Before block, 30 min after block
Pain scores (Numerical rating scale-NRS)
The primary aim is to compare NRS at the postoperative 24 h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded
Measured: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours
Secondary outcomes (1)
Need for rescue analgesia (tramadol)
The secondary aim is to compare rescue analgesia used in the postoperative 24 h.
Measured: Postoperative 24 hours period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start10 Feb 2024
- Primary completion10 Sep 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721052
- Sponsor's protocol ID
- Medipol Hospital 39
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not plan to share IPD
Publications
Pun M, Ng T, Vermeylen K, Tran J. Innervation of the hip joint: implications for regional anaesthesia and image-guided interventional pain procedures. BJA Educ. 2024 Jun;24(6):191-202. doi: 10.1016/j.bjae.2024.02.005. Epub 2024 Apr 8. No abstract available.
PubMed 38764441Vermeylen K, Soetens F, Leunen I, Hadzic A, Van Boxtael S, Pomes J, Prats-Galino A, Van de Velde M, Neyrinck A, Sala-Blanch X. The effect of the volume of supra-inguinal injected solution on the spread of the injectate under the fascia iliaca: a preliminary study. J Anesth. 2018 Dec;32(6):908-913. doi: 10.1007/s00540-018-2558-9. Epub 2018 Sep 24.
PubMed 30250982Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PubMed 30063657Nielsen ND, Madsen MN, Ostergaard HK, Bjorn S, Pedersen EM, Nielsen TD, Soballe K, Borglum J, Bendtsen TF. An iliopsoas plane block does not cause motor blockade-A blinded randomized volunteer trial. Acta Anaesthesiol Scand. 2020 Mar;64(3):368-377. doi: 10.1111/aas.13498. Epub 2019 Nov 13.
PubMed 31650529
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Ultrasound-guided Deep Iliacus Plane Block / Meta-PENG: Another Novel Fascial Plane Block
- ClinicalTrials.gov ID
- NCT06721052
- Acronym / sponsor ID
- Medipol Hospital 39
- Conditions
- Hip Fractures, Hip Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 6 Dec 2024 (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 components of the lumbar plexus and capture the articular branches of hip capsule may be effectively blocked by administering a relatively high volume of local anesthetic deep to the iliacus muscle at the level of the anterior inferior iliac spine. We can provide both the blockade of the pericapsular nerve group supplying the hip capsule and the cutaneous blockade. Here, we aimed to present our novel technique we named 'deep iliacus plane block (DIPB)'.
Detailed description
Many regional anesthesia techniques are used in hip surgeries for various goals, such as optimizing neuraxial positioning and relieving pain in the perioperative period, and have been the subject of clinical researches in the last few decades.
The lumbar plexus is important in administering anesthesia and analgesia during hip and knee surgeries. Comprising the femoral nerve (FN), lateral femoral cutaneous nerve (LFCN), and obturator nerve, it collaborates with the sacral plexus to ensure comprehensive innervation of the lower limb.
We hypothesized that by administering a relatively high volume of local anesthetic deep to the iliacus muscle at the level of the anterior inferior iliac spine (AIIS), we could effectively block the lumbar plexus components and capture the hip capsule's articular branches. We can ensure both the blockade of the pericapsular nerve group supplying the hip capsule and the cutaneous blockade. Here, we aimed to present our cadaveric evaluation and retrospective evaluation of patients underwent meta-PENG block, which we consider the proof-of-concept for our hypothesis of the technique we named 'deep iliacus plane block (DIPB)'.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group meta-PENG block | – | Drug: meta-Peng block, Drug: Postoperative analgesia managementWe performed meta-PENG block in patients who underwent hip surgery under spinal or general anesthesia |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent hip fracture surgery due to fracture or another reason
Key inclusion criteria (1 listed)
- ASA-1, ASA-2 and ASA-3 patients who underwent hip surgery under spinal or general anesthesia
Key exclusion criteria (1 listed)
- Anticoagulant drug use Known allergy to the medications to be used Infection in the area where the needle will be inserted Missing data
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 |
|---|---|---|
| meta-Peng blockThe convex transducer was positioned obliquely in a superolateral to inferomedial direction just above the femoral crest. Anatomical structures including AIIS, iliopubic eminence, sartorius muscle, iliopsoas muscle, psoas tendon, artery, vein, and iliac fascia were identified sono-anatomically. The AIIS was centered in the transducer image. To determine the insertion point of the rectus femoris tendon (RFT) on the AIIS, the transducer was rotated sagittally, and the level where the RFT ends cephalically was identified. After identifying the target, the transducer was obliquated again to visualize the IPE. The 22G x 100 mm block needle was advanced in-plane from lateral to inferomedial towards the potential space between the IPM and AIIS. After confirming the target plane with a few mL of saline, 30-40 mL of 0.25% bupivacain was applied to the area. The spread of injectate was observed beneath the IPM, below the psoas tendon, and around the iliacus muscle within the iliac fascia. | Drug | Group meta-PENG block |
| Postoperative analgesia managementWe ordered 400 mg intravenous ibuprofen for the patients every 8 hours during the postoperative period. We planned to perform 100 mg tramadol as a rescue analgesic if the patient's NRS score was above 4. We observed the patients for 24 hours in the postoperative period. | Drug | Group meta-PENG block |
Primary outcome
Pain scores (Numerical rating scale-NRS)
Time frame: Before block, 30 min after block
Comparison of NRS before block, after block, and during position for surgery
Pain scores (Numerical rating scale-NRS)
Time frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours
The primary aim is to compare NRS at the postoperative 24 h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded
1 secondary outcome
Need for rescue analgesia (tramadol)
Time frame: Postoperative 24 hours period
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 6 Dec 2024.
- Background: PubMed 38764441Pun M, Ng T, Vermeylen K, Tran J. Innervation of the hip joint: implications for regional anaesthesia and image-guided interventional pain procedures. BJA Educ. 2024 Jun;24(6):191-202. doi: 10.1016/j.bjae.2024.02.005. Epub 2024 Apr 8. No abstract available.
- Background: PubMed 30250982Vermeylen K, Soetens F, Leunen I, Hadzic A, Van Boxtael S, Pomes J, Prats-Galino A, Van de Velde M, Neyrinck A, Sala-Blanch X. The effect of the volume of supra-inguinal injected solution on the spread of the injectate under the fascia iliaca: a preliminary study. J Anesth. 2018 Dec;32(6):908-913. doi: 10.1007/s00540-018-2558-9. Epub 2018 Sep 24.
- Background: PubMed 30063657Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Background: PubMed 31650529Nielsen ND, Madsen MN, Ostergaard HK, Bjorn S, Pedersen EM, Nielsen TD, Soballe K, Borglum J, Bendtsen TF. An iliopsoas plane block does not cause motor blockade-A blinded randomized volunteer trial. Acta Anaesthesiol Scand. 2020 Mar;64(3):368-377. doi: 10.1111/aas.13498. Epub 2019 Nov 13.
- Individual participant dataSharing planned: No. We will not plan to share IPD
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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?
An observational study of Hip Fractures and Hip Injuries, run by Medipol 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 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 6 Dec 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?
Pain scores (Numerical rating scale-NRS) (time frame: Before block, 30 min after block). 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?
On the ClinicalTrials.gov record for NCT06721052, which also lists 4 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 6 Dec 2024.