Pericapsular Nerve Group Block for Positional Pain and Postoperative Analgesia in Hip Fractures

NCT05079087 | Unknown

• 1 other identifier: 01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are:

• Evaluate the effectiveness of the pericapsulare blockade of the femoral nerve, the accessory obturator nerve and the obturator nerve in patients with pertrochanteric fractures of the femur, during the pre-operative period for patient positioning manoeuvres (sitting position for performing spinal anaesthesia, mobilisation on the operating bed, etc.);
• Evaluate the consumption of opioids or hypnotics in the perioperative period, which are more responsible for the incidence of delirium in the elderly patient;
• Evaluate the duration and quality of postoperative analgesia and well-being.

Conditions

Pertrochanteric Fracture; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Change of the numerical rating scale for pain (NRS) during movement of the affected limb (extension of 20°) 30 minutes after the PENG block

  Change in NRS pre and 18 hours post performing the PENG block

Secondary Outcomes (4)

• Delirium

  Changne in score of the 4 AT rapid clinical test pre and 18 hours post performing block

• Rescue opiate use

  During the first 24 hours after discharge from the recovery room

• PONV

  During the first 24 hours after discharge from the recovery room

• Questionnaire on patient satisfaction

  From the beginning of the surgical procedure until 24 hours after discharge from the recovery room

Study Arms (2)

PENG BLOCK arm

EXPERIMENTAL

The first arm will consist of patients that undergo PENG block administering a mixture of Ropivacaine 0.5% + Dexamethasone 4 mg in a volume of 20 ml before performing the spinal anaesthesia.

Procedure: Pericapsular nerve group blockade

Ketamine- Midazolam arm

ACTIVE COMPARATOR

The second arm consist in Patients that will undergo sedation and analgesic treatment with Ketamine and Midazolam titrated to the best Verbal Rating Score without respiratory and cardiovascular depressant effect.

Drug: Midazolam Ketamine arm

Interventions

Pericapsular nerve group blockade PROCEDURE

The PENG-block will be administered under ultrasound (US) guidance with a low frequency curvilinear probe. The probe will be placed parallel to the inguinal crease at the level of the anterior superior iliac spine. Scanning will be done with gradual caudal movement of the probe. After the anterior inferior iliac spine (AIIS) is visible, the probe will be turned slightly medial until the hyperechoic continuous shadow of the superior pubic ramus is visible. The Psoas muscle with its prominent tendon will be identified just above the pubic ramus. The target is the plane between the 2 structures. While aligning the pubic ramus in the center of the image and targeting the pubic ramus just medial to the AIIS, a 22 Go 10 cm needle will be introduced and 20 ml of anesthetic solution administered.

Also known as: PENG block

PENG BLOCK arm

Midazolam Ketamine arm DRUG

Patients in the second group will undergo sedation and analgesic treatment with Ketamine and Midazolam titrated to the best Verbal Rating Score without respiratory and cardiovascular depressant effect.

Also known as: Analgosedation treatment

Ketamine- Midazolam arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a peritrocanteric femur fracture admitted to the orthopaedic ward

You may not qualify if:

• Patient refusal
• Lack of informed consent
• Pathological skin alterations
• Intertrigo at the puncture site level.
• Allergy to any of the drugs
• Coagulopathy
• Sepsis
• Use of direct oral anticoagulatns (DOACs)

Sponsors & Collaborators

• Azienda Sanitaria dell'Alto Adige: lead

Study Sites (1)

Azienda sanitaria Allo Adige ospedale di Merano

Meran, Bolzano, 39012, Italy

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Paolo Seraglio, MD

CONTACT

00390473267570; paolomarioenrico.seraglio@sabes.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: October 15, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

IT (1)