Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Hip Arthroplasty

Phase 4

Recruiting

• Conditions: Hip Osteoarthritis; Hip Pain Chronic; Hip Arthropathy
• Interventions: Drug: Dexamethasone; Drug: 0.9%sodium chloride; Drug: Dexmedetomidine

• Registration Number: NCT06233604
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for hip 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.

The safety of local anaesthesia is essential due to the much lower toxicity threshold of local anaesthetics. 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 where intravenous and perineural dexamethasone and Dexmedetomidine use have been compared in adults. However, there is a massive lack of research regarding spine surgery and the Erector Spinae 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

• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-31
• Status Verified: 2024-04
• Study Start: 2024-04-10
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29
• Primary Completion: 2025-03-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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.

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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
Placebo	0.9%sodium chloride	0.2% ropivacaine for erector spinae plane block
Dexmedetomidine	Dexmedetomidine	0.2% ropivacaine + 50ug Dexmedetomidine 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
NLR	48 hours after surgery	Neutrophil-to-lymphocyte ratio
PLR	48 hours after surgery	Platelet-to-lymphocyte ratio
Numerical Rating Scale [range 0:10]	24 hours after surgery	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Opioid consumption	48 hours after surgery	Total opiate consumption after surgery

Trial Locations

Locations (1)

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