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

Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Total Knee Arthroplasty

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Knee Arthritis; Knee Pain Chronic; Knee Disease
• Intervention / Treatment: Drug: Dexamethasone; Drug: Dexmedetomidine; Drug: 0.9% Sodium Chloride Injection

Detailed Description

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

After knee 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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Poznań
    • Poznan, Poznań, Poland, 61-701
      • Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone; 0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block	Drug: Dexamethasone; unilateral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block; Other Names: erector spinae plane block
Experimental: Dexmedetomidine; 0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block	Drug: Dexmedetomidine; unilateral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block; Other Names: erector spinae plane block
Placebo Comparator: Control group; 0.2% ropivacaine for erector spinae plane block	Drug: 0.9% Sodium Chloride Injection; unilateral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block; Other Names: placebo erector spinae plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
first need of opiate	Time after surgery when the patient needs opiate for the first time	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	4 hours after surgery
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	8 hours after surgery
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	12 hours after surgery
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	16 hours after surgery
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	20 hours after surgery
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	24 hours after surgery
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	36 hours after surgery
Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	48 hours after surgery
Opioid consumption	Total opioid consumption after surgery	48 hours after surgery
Nerve damage [range 0-4]	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)	12 hours after surgery
Nerve damage [range 0-4]	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)	24 hours after surgery
Nerve damage [range 0-4]	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)	48 hours after surgery

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Chair: Malgorzata Domagalska, M.D. PhD., Poznań University of Medical Science

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2024
• Primary Completion (Actual): March 3, 2026
• Study Completion (Actual): March 20, 2026

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Polycyclic Compounds; Imidazoles; Inorganic Chemicals; Chlorine Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Sodium Compounds; Chlorides; Hydrochloric Acid; Dexamethasone; Dexmedetomidine; Sodium Chloride
• Other Study ID Numbers: 107/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual patient data will be available two years following the completion of the trial
• IPD Sharing Time Frame: 2 years after finish study
• IPD Sharing Access Criteria: elligible researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No