Comparison of PENG Block and Fascia Iliaca Compartment Block in the Postoperative Pain Control of Hip Capsular Fracture

Sponsor
Consorci Sanitari de Terrassa (Other)
Overall Status
Recruiting
CT.gov ID
NCT05377541
Collaborator
(none)
88
1
19.1
4.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Surgical treatment of femur fracture

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
88 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of PENG Block and Fascia Iliaca Compartment Block in the Postoperative Pain Control of Hip Capsular Fracture
Actual Study Start Date :
Apr 29, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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.

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

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.

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

Outcome Measures

Primary Outcome Measures

  1. Post-surgical pain after the disappearance of the motor block [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.

  2. Pain 24 hours after surgery [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.

  3. Need for rescue analgesia [24 hours after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Consorci Sanitari de Terrassa Terrassa Barcelona Spain 8227

Sponsors and Collaborators

  • Consorci Sanitari de Terrassa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Carles Espinos Ramírez, Principal Investigator, Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier:
NCT05377541
Other Study ID Numbers:
  • 01-22-270-037
First Posted:
May 17, 2022
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Carles Espinos Ramírez, Principal Investigator, Consorci Sanitari de Terrassa
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2022