Use of Dexamethasone Via Two Different Methods in PENG Block

NCT ID: NCT06242028

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-30

Study Completion Date

2024-02-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain, Acute Postoperative Pain Hip Fractures

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group P (Perinuerally)

Ultrasound guided PENG block with perinuerally dexamethasone administration group

Group P

Intervention Type DRUG

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

Group S (Systematic)

Ultrasound guided PENG block with systemic dexamethasone administration group

Group S

Intervention Type 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.

Interventions

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Group P

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Perinuerally Systematic

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

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Ebru Kelsaka

Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ebru Kelsaka, Prof.Dr

Role: STUDY_DIRECTOR

Ondokuz Mayıs University

Locations

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Ondokuz Mayıs University

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 18723517 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21844549 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15494999 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28564673 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36964012 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25123271 (View on PubMed)

Other Identifiers

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PENDEX2022

Identifier Type: -

Identifier Source: org_study_id

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