- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05377541
Comparison of PENG Block and Fascia Iliaca Compartment Block in the Postoperative Pain Control of Hip Capsular Fracture
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hip fractures are a very common clinical situation in elderly patients and are associated with significant morbidity and mortality. In addition, they have a great social and economic impact that in most cases requires definitive surgical treatment.
Although it is a very common procedure, in proximal femur surgery there is great variability with respect to anesthetic procedures and their subsequent management. Subarachnoid anesthesia is the most commonly used for this type of surgery. During the last few years, different locoregional techniques have been described with the aim of improving perioperative analgesia in these patients. Some examples are the iliac fascia block, the 3-in-1 block or the femoral nerve block, which allow a lower consumption of opioids and reduce some adverse effects such as postoperative delirium.
The PENG (Pericapsular Nerve Group) block is a block recently described for pain management in proximal femoral surgery. It is a pure sensory block that was initially described as an analgesic technique for the treatment of acute pain after femoral fracture but has expanded its uses. Its target corresponds precisely to the described innervation of the anterior femoral capsule.
Regarding the other locoregional techniques mentioned above, these consist of non-selective blocks of the femoral, lateral femoral cutaneous and obturator nerves. Therefore, although the iliac fascia block is accepted for analgesic control of hip fracture, the PENG block is likely to be more effective because of its high selectivity.
For this reason, the investigators have decided to conduct a prospective cohort study comparing PENG block versus iliac fascia block with the aim of evaluating its effectiveness in the peri-surgical analgesia of intracapsular femoral fracture.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Carles Espinós Ramírez
- Phone Number: +34650125113
- Email: md071683@uic.es
Study Locations
-
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Barcelona
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Terrassa, Barcelona, Spain, 8227
- Recruiting
- Consorci Sanitari de Terrassa
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Contact:
- Carles Espinós Ramírez
- Phone Number: +34 650125113
- Email: md071683@uic.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with subcapital, basicervical or transcervical femoral fracture in whom definitive surgical treatment is decided.
- Patients who are candidates for nerve block plus intradural anesthesia.
- Patients who agree to participate in the study
Exclusion Criteria:
- Patients with dementia or cognitive impairment (EVN not evaluable)
- Polytraumatized patient
- Patient's refusal to participate in the study
- Patient's refusal to undergo intradural anesthesia or the blockade
- Patient with sensory or motor deficits prior to surgery.
- Patient with anticoagulation or antiplatelet therapy at the time of surgery.
- Hemodynamically unstable patient or patient who becomes unstable during surgery.
- Patient allergic to the local anesthetic.
- Patient with chronic pain in treatment
- Patient with capital femur fracture
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PENG block
To perform the PENG block, the patient will be placed in the supine position and with the convex transducer in a transverse plane over the anteroinferior iliac spine, the probe will be aligned with the iliopectineal eminence of the pubic ramus rotating about 45º medially.
|
Definitive surgical treatment of femur fracture.
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Fascia iliaca compartment block
To perform the iliac fascia block, the patient is placed in the supine position and with the linear transducer placed at the junction of the middle third with the lateral third of the inguinal ligament, the needle is inserted through the fascia lata and the iliac fascia.
|
Definitive surgical treatment of femur fracture.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-surgical pain after the disappearance of the motor block
Time Frame: Approximately from 1 to 2 hours after de surgery, when the effect of the spinal anesthesia disappears.
|
Pain will be assessed through the Verbal Numerical Scale (VNS).
The VNS is a numeric scale with a minimum value of 0 and a maximum of 10 where 0 means no pain and 10 maximum pain.
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Approximately from 1 to 2 hours after de surgery, when the effect of the spinal anesthesia disappears.
|
Pain 24 hours after surgery
Time Frame: 24 hours after surgery
|
Pain will be assessed through the Verbal Numerical Scale (VNS).
The VNS is a numeric scale with a minimum value of 0 and a maximum of 10 where 0 means no pain and 10 maximum pain.
|
24 hours after surgery
|
Need for rescue analgesia
Time Frame: 24 hours after surgery
|
24 hours after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Allard C, Pardo E, de la Jonquiere C, Wyniecki A, Soulier A, Faddoul A, Tsai ES, Bonnet F, Verdonk F. Comparison between femoral block and PENG block in femoral neck fractures: A cohort study. PLoS One. 2021 Jun 4;16(6):e0252716. doi: 10.1371/journal.pone.0252716. eCollection 2021.
- Jadon A, Mohsin K, Sahoo RK, Chakraborty S, Sinha N, Bakshi A. Comparison of supra-inguinal fascia iliaca versus pericapsular nerve block for ease of positioning during spinal anaesthesia: A randomised double-blinded trial. Indian J Anaesth. 2021 Aug;65(8):572-578. doi: 10.4103/ija.ija_417_21. Epub 2021 Aug 25.
- Acharya U, Lamsal R. Pericapsular Nerve Group Block: An Excellent Option for Analgesia for Positional Pain in Hip Fractures. Case Rep Anesthesiol. 2020 Mar 12;2020:1830136. doi: 10.1155/2020/1830136. eCollection 2020.
- Ueshima H, Otake H. RETRACTED: Clinical experiences of pericapsular nerve group (PENG) block for hip surgery. J Clin Anesth. 2018 Dec;51:60-61. doi: 10.1016/j.jclinane.2018.08.003. Epub 2018 Aug 8. No abstract available.
- Sahoo RK, Jadon A, Sharma SK, Peng PW. Peri-capsular nerve group block provides excellent analgesia in hip fractures and positioning for spinal anaesthesia: A prospective cohort study. Indian J Anaesth. 2020 Oct;64(10):898-900. doi: 10.4103/ija.IJA_450_20. Epub 2020 Oct 1. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-22-270-037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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