Clinical trial

Comparison of the Effects of Dexamethasone Administered Perinuerally and Dexamethasone Administered Systemically in PENG Block in Patients Operated for Femoral Neck Fracture

NCT06242028

Name

PENDEX2022

Description

Hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. Pericapsular nerve group block targets the hip capsule. The aim of this study is to investigate and compare the perioperative analgesic efficacy of PENG blocks applied investigation of the effect of perinuerally and systemic dexamethasone on pain scores in the first 24 hours of PENG block in patients undergoing hip fracture surgery under spinal anesthesia.

Trial arms

Trial start

2023-12-27

Estimated PCD

2024-08-27

Trial end

2024-12-27

Status

Active (not recruiting)

Treatment

Group P

In this group, US guided PENG block will be performed with 20 cc 0.25% bupivacaine and 4 mg dexamethasone.

Arms:

Group P (Perinuerally)

Other names:

Perinuerally

Group S

In this group, US guided PENG block will be performed with 20 cc 0.25% bupivacaine. In addition, 4 mg dexamethasone will be administered intravenously.

Arms:

Group S (Systematic)

Other names:

Systematic

Size

Primary endpoint

Pain scores on the Numeric Rating Scale (NRS)

Postoperative 0th, 6th,12th and 24th hours

Eligibility criteria

Inclusion Criteria: * 50-85 years old * Patients who underwent surgery for femoral neck fracture under spinal anesthesia with PENG block * Patients of either sex with a body mass index (BMI) \< 35 kg/m2 * ASA II-IV patients * Patients signing the informed consent form Exclusion Criteria: * ASA-V patients * Alcohol, drug addiction * Patients with a history of opioid drug use for more than four weeks * Patients with chronic pain disorders (patients on regular analgesics \>3 months) * Patients with a history of local anesthetic or opioid allergy or hypersensitivity * Patient group in whom regional anesthesia is contraindicated (coagulopathy, INR (international correction ratio) not within normal limits, thrombocytopenia or platelet dysfunction, infection at the injection site) * Those with severe psychiatric illnesses such as psychosis, dementia, etc. that limit their cooperation with the patient * Patients who do not give consent/ do not want to participate * Patients who were evaluated as failed block on dermatomal examination after block application

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 44, 'type': 'ESTIMATED'}}

Updated at

2024-05-14

1 organization

1 product

1 drug

4 indications

Organization

Ondokuz Mayıs University

Product

Group P

Indication

Pain