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CompletedNCT06242028Updated Feb 24, 2025

Use of Dexamethasone Via Two Different Methods in PENG Block

An observational study in Pain, Acute, Postoperative Pain and Hip Fractures, sponsored by Ondokuz Mayıs University. Completed at 1 site in Turkey. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by Ondokuz Mayıs University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
44
Ages
50 Years to 85 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pain, Acute
  • Postoperative Pain
  • Hip Fractures

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03

In context

Hip Fractures

822 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.

This study's enrollment of 44 is below the median of 140 across 268 observational studies indexed under Hip Fractures.

Browse Hip Fractures studies →

Lead sponsor

Ondokuz Mayıs University is the lead sponsor of 262 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
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

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
44 participants (actual)
Patient registry
No

Groups and cohorts

  • Group P (Perinuerally)

    Ultrasound guided PENG block with perinuerally dexamethasone administration group

    Drug: Group P

  • Group S (Systematic)

    Ultrasound guided PENG block with systemic dexamethasone administration group

    Drug: Group S

Interventions

  • DrugGroup P

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

    Also known as: Perinuerally

  • DrugGroup 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.

    Also known as: Systematic

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What researchers measure

Primary outcomes

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

    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.

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

Secondary outcomes

  1. Postoperative nausea and vomiting

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

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

  2. The degree of motor block

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

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

  3. The degree of sensory block

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

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

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Study locations

1 site
  • Ondokuz Mayıs University
    Samsun, Turkey
08

References and documents

Publications

  • Maxwell MJ, Moran CG, Moppett IK. Development and validation of a preoperative scoring system to predict 30 day mortality in patients undergoing hip fracture surgery. Br J Anaesth. 2008 Oct;101(4):511-7. doi: 10.1093/bja/aen236. Epub 2008 Aug 21. PubMed 18723517 ↗
  • Abou-Setta AM, Beaupre LA, Rashiq S, Dryden DM, Hamm MP, Sadowski CA, Menon MR, Majumdar SR, Wilson DM, Karkhaneh M, Mousavi SS, Wong K, Tjosvold L, Jones CA. Comparative effectiveness of pain management interventions for hip fracture: a systematic review. Ann Intern Med. 2011 Aug 16;155(4):234-45. doi: 10.7326/0003-4819-155-4-201108160-00346. PubMed 21844549 ↗
  • Parker MJ, Handoll HH, Griffiths R. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD000521. doi: 10.1002/14651858.CD000521.pub2. PubMed 15494999 ↗
  • Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898. PubMed 28564673 ↗
  • Kukreja P, Uppal V, Kofskey AM, Feinstein J, Northern T, Davis C, Morgan CJ, Kalagara H. Quality of recovery after pericapsular nerve group (PENG) block for primary total hip arthroplasty under spinal anaesthesia: a randomised controlled observer-blinded trial. Br J Anaesth. 2023 Jun;130(6):773-779. doi: 10.1016/j.bja.2023.02.017. Epub 2023 Mar 22. PubMed 36964012 ↗
  • Albrecht E, Kern C, Kirkham KR. A systematic review and meta-analysis of perineural dexamethasone for peripheral nerve blocks. Anaesthesia. 2015 Jan;70(1):71-83. doi: 10.1111/anae.12823. Epub 2014 Aug 14. PubMed 25123271 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06242028
Lead sponsor
Ondokuz Mayıs University
Responsible party
Ebru Kelsaka (Professor Doctor, Ondokuz Mayıs University) — Principal investigator
First posted
Feb 5, 2024
Start date
Aug 30, 2023
Primary completion
Oct 30, 2023
Completion
Feb 5, 2024
Last update
Feb 24, 2025

Study contacts

Ebru Kelsaka, Prof.Dr
study director · Ondokuz Mayıs University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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