Comparison of the Effects of Perineural Dexamethasone and Systemic Dexamethasone in PENG Block

May 11, 2024 updated by: Ebru Kelsaka, Ondokuz Mayıs University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

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.

Study Type

Observational

Enrollment (Estimated)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey
        • Ondokuz Mayıs University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 50-85 years who underwent surgery for femoral neck fracture and underwent PENG block

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group S (Systematic)
Ultrasound guided PENG block with systemic dexamethasone administration group
Drug: 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.
Other Names:
  • Systematic
Group P (Perinuerally)
Ultrasound guided PENG block with perinuerally dexamethasone administration group
Drug: Group P
In this group, US guided PENG block will be performed with 20 cc 0.25% bupivacaine and 4 mg dexamethasone.
Other Names:
  • Perinuerally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative 0th, 6th,12th and 24th hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative 6th, 12th and 24th hours
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.
Postoperative 6th, 12th and 24th hours
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.
Postoperative 6th, 12th and 24th hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Investigators

  • Study Director: Ebru Kelsaka, Prof.Dr, Ondokuz Mayıs University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2023

Primary Completion (Estimated)

August 27, 2024

Study Completion (Estimated)

December 27, 2024

Study Registration Dates

First Submitted

January 28, 2024

First Submitted That Met QC Criteria

January 28, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PENDEX2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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