Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorPoznan University of Medical Sciences

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 65 years

Scheduled for primary unilateral total knee arthroplasty under standardized anesthetic protocol

ASA physical status II-III (or I-III, zależnie jak planujesz)

Ability to understand the study procedures and provide written informed consent

Disqualifiers

Contraindications to peripheral nerve blocks (infection at injection site, coagulopathy, patient refusal)

Known allergy or hypersensitivity to amide local anesthetics, dexamethasone or dexmedetomidine

Chronic opioid therapy or opioid use > 30 mg oral morphine equivalents per day in the last 3 months

Severe hepatic or renal impairment

Trial design

Treatments tested in this trial

  • Ropivacaine 0.2% Injectable Solution
  • Dexamethasone 4mg
  • Dexmedetomidine

Treatment groups

96 Participants
are divided into 3 treatment groups