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Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA

ConditionKnee Osteoarthritis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ropivacaine 0.2% Injectable Solution

    Drug

    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.

  • Dexamethasone 4mg

    Drug

    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).

  • Dexmedetomidine

    Drug

    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

Treatment groups

96 Participants
are divided into 3 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: Perineural DexamethasoneExperimental treatment 1 intervention
Group C: Perineural DexmedetomidineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative opioid consumption in the first 24 hours after surgery

Total dose of rescue opioid analgesics administered within the first 24 hours after surgery, converted to intravenous morphine equivalents (mg). All opioids given in the post-anesthesia care unit and on the ward will be recorded and converted using standard equianalgesic ratios.

Time frame
0-24 hours postoperatively

Secondary outcomes

1

Pain intensity at rest

Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)

Time frame
6 hours postoperatively
2

Pain intensity at rest

Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)

Time frame
12 hours postoperatively
3

Pain intensity at rest

Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)

Time frame
24 hours postoperatively
4

Pain intensity at rest

Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)

Time frame
48 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Poznan University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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