Actively Recruiting

Phase Not Applicable
Age: 65Years - 100Years
All Genders
NCT07386600

Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA

Led by Poznan University of Medical Sciences · Updated on 2026-02-04

96

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This randomized, double-blind, controlled trial is designed to compare the analgesic efficacy and safety of perineural dexamethasone versus perineural dexmedetomidine as adjuvants to ropivacaine for ultrasound-guided interspace between the popliteal artery and the capsule of the posterior knee (iPACK) and adductor canal blocks in patients undergoing primary unilateral total knee arthroplasty (TKA). Elderly participants scheduled for elective TKA will be randomized into three parallel groups: ropivacaine alone (control), ropivacaine combined with perineural dexamethasone, or ropivacaine combined with perineural dexmedetomidine. The primary objective is to determine whether the addition of either adjuvant reduces postoperative opioid consumption compared with ropivacaine alone and to assess potential differences in analgesic efficacy between the two adjuvants. Secondary outcomes include pain intensity at rest and during mobilization, time to first rescue analgesia, quality of early functional recovery, and the incidence of adverse events, including postoperative nausea and vomiting, motor impairment, and hemodynamic instability.

CONDITIONS

Official Title

Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA

Who Can Participate

Age: 65Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older
  • Scheduled for primary unilateral total knee arthroplasty under standardized anesthetic protocol
  • ASA physical status II-III (or I-III, depending on planning)
  • Ability to understand the study procedures and provide written informed consent
Not Eligible

You will not qualify if you...

  • Contraindications to peripheral nerve blocks such as infection at injection site, coagulopathy, or patient refusal
  • Known allergy or hypersensitivity to amide local anesthetics, dexamethasone, or dexmedetomidine
  • Chronic opioid therapy or opioid use greater than 30 mg oral morphine equivalents per day in the last 3 months
  • Severe liver or kidney impairment
  • Significant cognitive impairment or inability to cooperate with pain assessment
  • Participation in another interventional trial affecting pain or analgesic consumption

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Poznan University of Medical Sciences

Poznan, Poland, 62-701

Actively Recruiting

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Research Team

M

Malgorzata Reysner, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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