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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05377541
Other study ID # 01-22-270-037
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 29, 2022
Est. completion date December 2023

Study information

Verified date March 2023
Source Consorci Sanitari de Terrassa
Contact Carles Espinós Ramírez
Phone +34650125113
Email md071683@uic.es
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 88
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Surgical treatment of femur fracture
Definitive surgical treatment of femur fracture.

Locations

Country Name City State
Spain Consorci Sanitari de Terrassa Terrassa Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Consorci Sanitari de Terrassa

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Post-surgical pain after the disappearance of the motor block 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. Approximately from 1 to 2 hours after de surgery, when the effect of the spinal anesthesia disappears.
Primary Pain 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
Primary Need for rescue analgesia 24 hours after surgery
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