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Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA

NCT07386600 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-02-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ropivacaine 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.

DRUG

Dexamethasone 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).

DRUG

Dexmedetomidine

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

Sponsors & Collaborators

  • Poznan University of Medical Sciences

    lead OTHER

Principal Investigators

  • Malgorzata Reysner, MD PhD · Poznan University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-01-01
Completion
2027-01-31

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07386600 on ClinicalTrials.gov