Use of Dexamethasone Via Two Different Methods in PENG Block

NCT06242028 | Completed

• 1 other identifier: PENDEX2022
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Acute; Postoperative Pain; Hip Fractures

Outcome Measures

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.

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

Secondary Outcomes (3)

• Postoperative nausea and vomiting

  Postoperative 6th, 12th and 24th hours

• The degree of motor block

  Postoperative 6th, 12th and 24th hours

• The degree of sensory block

  Postoperative 6th, 12th and 24th hours

Study Arms (2)

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

Group P DRUG

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

Also known as: Perinuerally

Group P (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.

Also known as: Systematic

Group S (Systematic)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 18723517 BACKGROUND

• 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.

  PMID: 21844549 BACKGROUND

• 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.

  PMID: 15494999 BACKGROUND

• 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.

  PMID: 28564673 BACKGROUND

• 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.

  PMID: 36964012 BACKGROUND

• 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.

  PMID: 25123271 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative; Hip Fractures

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Ebru Kelsaka, Prof.Dr

  Ondokuz Mayıs University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: August 30, 2023
• Primary Completion: October 30, 2023
• Study Completion: February 5, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

TU (1)