Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA
Recruiting · NCT07386600 · Interventional (participants receive a specific treatment) · Lead sponsor: Poznan University of Medical Sciences
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Poznan University of Medical Sciences - Poznan, Poland