Dexamethasone Vs. Dexmedetomidine for ESPB in Pain Management After Knee Arthroplasty

Phase 4

Recruiting

• Conditions: Knee Arthritis; Knee Disease; Knee Osteoarthritis; Knee Pain Chronic
• Interventions: Drug: Dexamethasone; Drug: Dexmedetomidine; Drug: 0.9% Sodium Chloride Injection

• Registration Number: NCT06470100
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for knee arthroplasty

Detailed Description

This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for spine surgery.

After spine surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

Local anaesthesia's much lower toxicity threshold makes it essential for its safety. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.

There is considerable research comparing intravenous and perineural dexamethasone and Dexmedetomidine use in orthopaedic surgeries. However, there is a massive lack of research regarding knee surgery and the Erector Spine Plane Block.

In this study, investigators compare perineural Dexamethasone and Dexmedetomidine.

The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-24
• Study Start: 2024-08-13
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-07-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• patients undergoing primary hip arthroplasty
• aged >18 years and <100 years
• ASA physical status 1, 2 or 3.

Exclusion Criteria

• if they refused to participate,
• had a history of opioid abuse,
• had an infection of the site of needle puncture,
• were less than 18 years of age,
• were postponed as having ASA 4 or 5,
• had an allergy to any of the drugs used in the study,
• renal failure (estimated glomerular filtration rate <15ml/min/1.73m2),
• liver failure,
• known or suspected coagulopathy,
• pre-existing anatomical or neurological disorders in the lower extremities,
• intellectual disability with problems in pain evaluation,
• severe psychiatric illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone	0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block
Dexmedetomidine	Dexmedetomidine	0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block
Control group	0.9% Sodium Chloride Injection	0.2% ropivacaine for erector spinae plane block

Primary Outcome Measures

Name	Time	Method
first need of opiate	48 hours after surgery	Time after surgery when the patient needs opiate for the first time

Secondary Outcome Measures

Name	Time	Method
Opioid consumption	48 hours after surgery	Total opioid consumption after surgery
Numerical Rating Scale [range 0:10]	48 hours after surgery	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Nerve damage [range 0-4]	48 hours after surgery	Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznan, Poznań, Poland