- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06721052
Retrospective Evaluation of Efficacy of Meta-PENG Block
Retrospective Evaluation of Ultrasound-guided Deep Iliacus Plane Block / Meta-PENG: Another Novel Fascial Plane Block
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Bagcilar
-
Istanbul, Bagcilar, Turkey, 34070
- Istanbul Medipol University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ASA-1, ASA-2 and ASA-3 patients who underwent hip surgery under spinal or general anesthesia
Exclusion Criteria:
Anticoagulant drug use Known allergy to the medications to be used Infection in the area where the needle will be inserted Missing data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group meta-PENG block
We performed meta-PENG block in patients who underwent hip surgery under spinal or general anesthesia
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Before block, 30 min after block
|
|
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
|
Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Need for rescue analgesia (tramadol)
Time Frame: Postoperative 24 hours period
|
The secondary aim is to compare rescue analgesia used in the postoperative 24 h.
|
Postoperative 24 hours period
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Vermeylen 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.
- Giron-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.
- Nielsen 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Medipol Hospital 39
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Fractures
-
Khoo Teck Puat HospitalMinistry of Health, SingaporeActive, not recruitingHip Fracture Surgeries | Post-operative Hip Fractures RecoverySingapore
-
Smith & Nephew, Inc.Terminated
-
Medical Centre LeeuwardenNot yet recruitingHip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)Netherlands
-
San Giovanni di Dio HospitalRecruitingHip Surgery | Hip ArthroplastyItaly
-
Gaziantep City HospitalCompletedFemoral Neck Fractures | Hip SurgeryTurkey (Türkiye)
-
Carilion ClinicCompleted
-
Sheffield Teaching Hospitals NHS Foundation TrustRecruitingHip FractureUnited Kingdom
-
JointResearchRecruitingHip Fractures (ICD-10 72.01-72.2)Netherlands
-
Oslo University HospitalDiakonhjemmet HospitalCompletedHip Fractures | Trochanteric Fractures | Intertrochanteric FracturesNorway
-
Tel-Aviv Sourasky Medical CenterUnknownIntertrochanteric Fractures of the HipIsrael
Clinical Trials on meta-Peng block
-
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training...RecruitingPostoperative Pain | Hip Fracture | Regional AnesthesiaTurkey (Türkiye)
-
Ankara City Hospital BilkentActive, not recruitingPENG Block | Hip Arthroplasty, Total | QoR-15 | Numeric Rating ScaleTurkey (Türkiye)
-
Fatih Sultan Mehmet Training and Research HospitalCompletedPostoperative Pain | Hip Fractures | Postoperative Delirium (POD) | Hip ArthroplastyTurkey (Türkiye)
-
Mansoura UniversityCompleted
-
Ain Shams UniversityCompleted
-
Ospedale Edoardo BassiniRecruitingRegional Anesthesia Morbidity | Arthropathy of Hip | Opioid Consumption | Hip Arthropathy | Complication of Anesthesia | Locoregional Anesthesia | Hospital Stay, Length of Stay in Hospital From Time of Surgery Till DischargeItaly
-
Cairo UniversityNot yet recruitingAnesthesia for Hip Surgery
-
Mansoura UniversityCompletedShoulder SurgeryEgypt
-
Alexandria UniversityNot yet recruitingHip Fracture | Antithrombotic Therapy | PENG BlockEgypt
-
Ankara City Hospital BilkentRecruiting