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Completed

NCT Number: NCT06242028

Use of Dexamethasone Via Two Different Methods in PENG Block

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.

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Key information

About this study

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.

44 ASA II-IV patients between 50-80 years of age who will be operated for femoral neck fractures will be included in the study.

PENG block is routinely used in our clinic to provide postoperative analgesia in hip surgery. Depending on the comorbid conditions of the patients, dexamethasone may be added as an adjuvant agent to improve the quality of the block. We aimed to observe the systemic and perinuerally effects of dexamethasone used in PENG block in patients operated for femoral neck fracture in our clinic.

In this observational and prospective study, patients operated for femoral neck fracture and treated with PENG block will be analyzed in the postoperative period. Pain scores, degree of nausea and vomiting, recovery time of sensory and motor block, and blood glucose levels in the first 24 hours will be recorded in patients who received dexamethasone perinuerally and in patients who received systemic dexamethasone intravenously. In addition, the time to first analgesic requirement, mobilization time and hospital stay of the two groups will also be recorded.

The anesthesiologist performing the block will not participate in the pain monitoring of the patients. Postoperative pain assessment and data collection will be performed by another anesthesiologist blinded to the study. For the quality and standardization of the block, the block will be performed by an experienced anesthesiologist who has performed the block successfully and without complications at least 20 times before.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group P

Drug

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

Other names: Perinuerally

Group S

Drug

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.

Other names: Systematic

Primary outcomes

  1. Pain scores on the Numeric Rating Scale (NRS)

    Time frame: Postoperative 0th, 6th,12th and 24th hours

    Changes in Numeric Rating Scale (NRS) at rest and in activity will be recorded at intervals. At 0-6-12-24 hours, pain will be evaluated with the NRS score in two different situations.

    Patients will be informed about the Numeric Rating Scale used in the assessment of pain and pain intensity will be determined at rest and 24 hours postoperatively during 15 degrees passive leg raising. Patients will be asked to express their pain intensity numerically between 0 and 10, with 0 for no pain and 10 for the most severe pain.

Secondary outcomes

  1. Postoperative nausea and vomiting

    Time frame: Postoperative 6th, 12th and 24th hours

    The severity of nausea and vomiting was determined by a four-point Verbal Descriptive Scale.

  2. The degree of motor block

    Time frame: Postoperative 6th, 12th and 24th hours

    The degree of motor block will be evaluated with the Bromage scale.

  3. The degree of sensory block

    Time frame: Postoperative 6th, 12th and 24th hours

    The degree of sensory block will be evaluated with the Pinprick test.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Use of Dexamethasone Via Two Different Methods in PENG Block for Patients Undergoing Femoral Fracture Surgery

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 5, 2024
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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