Clinical trial NCT06242028: Use of Dexamethasone Via Two Different Methods in PENG Block
Official title: Use of Dexamethasone Via Two Different Methods in PENG Block for Patients Undergoing Femoral Fracture Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Acute
Postoperative Pain
Hip Fractures
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 50-85 years who underwent surgery for femoral neck fracture and underwent PENG block

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain scores on the Numeric Rating Scale (NRS)
timeFrame: Postoperative 0th, 6th,12th and 24th hours
Secondary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: Postoperative 6th, 12th and 24th hours
measure: The degree of motor block
timeFrame: Postoperative 6th, 12th and 24th hours
measure: The degree of sensory block
timeFrame: Postoperative 6th, 12th and 24th hours
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
Study officials:
affiliation: Ondokuz Mayıs University
name: Ebru Kelsaka, Prof.Dr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.