RecruitingNot ApplicableNCT07386600

Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA

Perineural Dexamethasone Versus Perineural Dexmedetomidine as Adjuvants to Ropivacaine in iPACK and Adductor Canal Blocks for Total Knee Arthroplasty: A Randomized, Double-Blind, Controlled Trial


Sponsor

Poznan University of Medical Sciences

Enrollment

96 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 65 YearsMax Age: 100 Years

Inclusion Criteria4

  • 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

Exclusion Criteria6

  • 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
  • Significant cognitive impairment, inability to cooperate with pain assessment
  • Participation in another interventional trial affecting pain or analgesic consumption

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Interventions

DRUGRopivacaine 0.2% Injectable Solution

Ultrasound-guided iPACK block and adductor canal block are performed using ropivacaine 0.2% in a standardized volume per block (20 mL for iPACK and 20 mL for ACB; adjust according to protocol). No adjuvant is added to the local anesthetic solution.

DRUGDexamethasone 4mg

Ultrasound-guided iPACK block and adductor canal block are performed using ropivacaine 0.2% in a standardized volume per block (20 mL + 20 mL). Preservative-free dexamethasone is added to the local anesthetic solution at a dose of (2 x 2 mg).

DRUGDexmedetomidine

Ultrasound-guided iPACK block and adductor canal block are performed using ropivacaine 0.2% in a standardized volume per block (20 mL + 20 mL). Dexmedetomidine is added to the local anesthetic solution at a dose of 25ug, distributed between both blocks according to the study protocol


Locations(1)

Poznan University of Medical Sciences

Poznan, Poland

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NCT07386600


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