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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06242028
• Other study ID #: PENDEX2022
• Status: Active, not recruiting
• Start date: December 27, 2023
• Est. completion date: December 27, 2024

Study information

• Verified date: February 2024
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: December 27, 2024
• Est. primary completion date: August 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Fractures
• Pain, Acute
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative nausea and vomiting	The severity of nausea and vomiting was determined by a four-point Verbal Descriptive Scale.	Postoperative 6th, 12th and 24th hours
Secondary	The degree of motor block	The degree of motor block will be evaluated with the Bromage scale.	Postoperative 6th, 12th and 24th hours
Secondary	The degree of sensory block	The degree of sensory block will be evaluated with the Pinprick test.	Postoperative 6th, 12th and 24th hours