Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA

NCT07386600 | Recruiting

• 1 other identifier: 13/2025
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Knee Osteoarthritis

Outcome Measures

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.

  0-24 hours postoperatively

Secondary Outcomes (12)

• Pain intensity at rest

  6 hours postoperatively

• Pain intensity at rest

  12 hours postoperatively

• Pain intensity at rest

  24 hours postoperatively

• Pain intensity at rest

  48 hours postoperatively

• Pain intensity during mobilization

  24 hours postoperatively

Study Arms (3)

Control

ACTIVE COMPARATOR

Patients receive ultrasound-guided iPACK block and adductor canal block (ACB) on the operative limb with ropivacaine 0.2% alone, without any perineural adjuvant.

Drug: Ropivacaine 0.2% Injectable Solution

Perineural Dexamethasone

EXPERIMENTAL

Patients receive ultrasound-guided iPACK and ACB with ropivacaine 0.2% combined with perineural dexamethasone.

Drug: Dexamethasone 4mg

Perineural Dexmedetomidine

EXPERIMENTAL

Patients receive ultrasound-guided iPACK and ACB with ropivacaine 0.2% combined with perineural dexmedetomidine.

Drug: Dexmedetomidine

Interventions

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.

Control

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).

Perineural Dexamethasone

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

Perineural Dexmedetomidine

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 62-701, Poland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ropivacaine; Dexamethasone; Dexmedetomidine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Malgorzata Reysner, MD PhD

  Poznan University of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Malgorzata Reysner, MD PhD

CONTACT

+48 61 873 83 03; mreysner@ump.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: February 4, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 4, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available beginning 6 months after publication of the main results and for a period of at least 5 years.
• Access Criteria: Data will be shared with qualified researchers for legitimate scientific purposes upon reasonable request. Access requires submission of a methodologically sound proposal, approval by the study investigators, and a data use agreement.

Locations

PL (1)