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

NCT ID: NCT06470100

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-13

Study Completion Date

2025-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Knee Osteoarthritis Knee Arthritis Knee Disease Knee Pain Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

0.2% ropivacaine for erector spinae plane block

Group Type PLACEBO_COMPARATOR

0.9% Sodium Chloride Injection

Intervention Type DRUG

unilateral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block

Dexamethasone

0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

unilateral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block

Dexmedetomidine

0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

unilateral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block

Interventions

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0.9% Sodium Chloride Injection

unilateral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block

Intervention Type DRUG

Dexamethasone

unilateral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block

Intervention Type DRUG

Dexmedetomidine

unilateral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block

Intervention Type DRUG

Other Intervention Names

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placebo erector spinae plane block erector spinae plane block erector spinae plane block

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malgorzata Domagalska, M.D. PhD.

Role: STUDY_CHAIR

Poznań University of Medical Science

Locations

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Poznan University of Medical Sciences

Poznan, Poznań, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Malgorzata Domagalska, M.D. Ph.D.

Role: CONTACT

+48 61 8738327

Malgorzata Domagalska, M.D. Ph.D.

Role: CONTACT

+48 61 8738327

Facility Contacts

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Malgorzata Domagalska, Ph.D.

Role: primary

608762068

Other Identifiers

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107/24

Identifier Type: -

Identifier Source: org_study_id

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