Knee OsteoarthritisNCT07386600
Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA
A study testing Ropivacaine 0.2% Injectable Solution, Dexamethasone 4mg and Dexmedetomidine in people with Knee Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Ropivacaine 0.2% Injectable Solution, Dexamethasone 4mg and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePoland
- Study dates
- 5 Feb 2026to 2 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- Scheduled for primary unilateral total knee arthroplasty under standardized anesthetic protocol
- ASA physical status I-III
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Total knee arthroplasty (TKA) is associated with substantial postoperative pain, which may delay rehabilitation, prolong hospital stay, and increase opioid consumption. Ultrasound-guided peripheral nerve blocks are an integral component of multimodal analgesia for TKA, particularly the interspace between the popliteal artery and the capsule of the posterior knee (iPACK) block and the adductor canal block (ACB). These techniques provide effective analgesia while preserving quadriceps motor function, thereby facilitating early mobilization. Ropivacaine is the most commonly used local anesthetic for iPACK and ACB; however, its relatively limited duration often necessitates additional analgesic interventions.
Perineural adjuvants have attracted increasing interest as a means to prolong block duration and enhance the quality of peripheral nerve blockade. Dexamethasone and dexmedetomidine are among the most extensively studied adjuvants; however, their relative clinical efficacy and safety when administered perineurally in TKA remain uncertain. Dexamethasone has been shown to prolong block duration and reduce postoperative pain and opioid requirements, likely through anti-inflammatory and glucocorticoid-mediated mechanisms. Dexmedetomidine, an α2-adrenergic agonist, may further enhance analgesia and sensory block duration but has been associated with adverse effects such as sedation and bradycardia in susceptible patients. Comparative evidence between these agents in the specific context of combined iPACK and ACB is limited, and no clear consensus currently exists regarding their optimal use.
This randomized, double-blind, controlled clinical trial is designed to compare the efficacy and safety of perineural dexamethasone versus perineural dexmedetomidine as adjuvants to ropivacaine for ultrasound-guided iPACK and adductor canal blocks in elderly patients undergoing primary unilateral total knee arthroplasty. Eligible participants will be randomized into three parallel groups: ropivacaine alone (control), ropivacaine with perineural dexamethasone, or ropivacaine with perineural dexmedetomidine. All nerve blocks will be performed according to a standardized protocol by experienced anesthesiologists. Surgical, anesthetic, and postoperative analgesic management will be standardized across groups to minimize potential confounding factors. Participants, care providers, investigators, block practitioners, nursing staff, and outcome assessors will remain blinded to treatment allocation.
The primary outcome is cumulative opioid consumption during the first 24 postoperative hours, expressed as intravenous morphine equivalents. Secondary outcomes include pain intensity at rest and during mobilization, time to first rescue analgesia, motor-sparing profile, hemodynamic effects, quality of early recovery, and the incidence of adverse events such as postoperative nausea and vomiting, hypotension, bradycardia, and neurological symptoms. Functional recovery will additionally be evaluated using standardized physiotherapy milestones.
It is hypothesized that both perineural dexamethasone and dexmedetomidine will reduce postoperative opioid consumption compared with ropivacaine alone, and that one adjuvant may demonstrate superior analgesic efficacy or a more favorable safety profile. The findings of this study may provide clinically relevant evidence to guide the selection of perineural adjuvants for iPACK and adductor canal blocks in total knee arthroplasty, with the potential to improve pain control, accelerate rehabilitation, and reduce opioid exposure in an elderly, at-risk population.
- Conditions
- Knee Osteoarthritis
- Being tested
- Ropivacaine 0.2% Injectable Solution, Dexamethasone 4mg, Dexmedetomidine
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2% Injectable SolutionDrug
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 4mgDrug
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).
DexmedetomidineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ropivacaine 0.2% Injectable Solution |
| Perineural Dexamethasone | Experimental | Patients receive ultrasound-guided iPACK and ACB with ropivacaine 0.2% combined with perineural dexamethasone. Receives: Drug: Dexamethasone 4mg |
| Perineural Dexmedetomidine | Experimental | Patients receive ultrasound-guided iPACK and ACB with ropivacaine 0.2% combined with perineural dexmedetomidine. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-24 hours postoperatively
Secondary outcomes (12)
Pain intensity at rest
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Measured: 6 hours postoperatively
Pain intensity at rest
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Measured: 12 hours postoperatively
Pain intensity at rest
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Measured: 24 hours postoperatively
Pain intensity at rest
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Measured: 48 hours postoperatively
Pain intensity during mobilization
Pain during active knee flexion and mobilization (e.g., physiotherapy session) assessed using NRS (0-10)
Measured: 24 hours postoperatively
Pain intensity during mobilization
Pain during active knee flexion and mobilization (e.g., physiotherapy session) assessed using NRS (0-10)
Measured: 48 hours postoperatively
Time to first rescue analgesia
Time from completion of the iPACK and ACB blocks to the administration of the first dose of rescue opioid analgesic (in minutes).
Measured: 0-48 hours postoperatively
Incidence of postoperative nausea and vomiting (PONV)
Number of patients with at least one episode of nausea and/or vomiting requiring antiemetic treatment during the first 24 and 48 hours after surgery.
Measured: 0-48 hours postoperatively
Motor function of the operated limb
Quadriceps muscle strength (knee extension and hip adduction) assessed using the Medical Research Council (MRC) scale, ranging from 0 (no muscular contraction) to 5 (normal strength), to evaluate the motor-sparing profile of each analgesic regimen.
Measured: 6 hours postoperatively
Motor function of the operated limb
Quadriceps muscle strength (knee extension and hip adduction) assessed using the Medical Research Council (MRC) scale, ranging from 0 (no muscular contraction) to 5 (normal strength), to evaluate the motor-sparing profile of each analgesic regimen.
Measured: 12 hours postoperatively
Motor function of the operated limb
Quadriceps muscle strength (knee extension and hip adduction) assessed using the Medical Research Council (MRC) scale, ranging from 0 (no muscular contraction) to 5 (normal strength), to evaluate the motor-sparing profile of each analgesic regimen.
Measured: 24 hours postoperatively
Block-related and systemic adverse events
Incidence of bradycardia, hypotension, oversedation, local anesthetic systemic toxicity (LAST), neurological deficits, signs of infection at the injection site, or any serious adverse events possibly related to the study drugs or blocks.
Measured: Intraoperative and up to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start5 Feb 2026
- Primary completion30 Sep 2026
- Study completion2 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malgorzata Reysner, MD PhD, Study chair, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386600
- Sponsor's protocol ID
- 13/2025
- Status last verified
- Nov 2026
- First submitted
- 4 Dec 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in the published article will be made available after de-identification. Data will include demographic characteristics, perioperative variables, intervention details, and primary and secondary outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07386600
- Acronym / sponsor ID
- 13/2025
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 2 Oct 2026 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Total knee arthroplasty (TKA) is associated with substantial postoperative pain, which may delay rehabilitation, prolong hospital stay, and increase opioid consumption. Ultrasound-guided peripheral nerve blocks are an integral component of multimodal analgesia for TKA, particularly the interspace between the popliteal artery and the capsule of the posterior knee (iPACK) block and the adductor canal block (ACB). These techniques provide effective analgesia while preserving quadriceps motor function, thereby facilitating early mobilization. Ropivacaine is the most commonly used local anesthetic for iPACK and ACB; however, its relatively limited duration often necessitates additional analgesic interventions.
Perineural adjuvants have attracted increasing interest as a means to prolong block duration and enhance the quality of peripheral nerve blockade. Dexamethasone and dexmedetomidine are among the most extensively studied adjuvants; however, their relative clinical efficacy and safety when administered perineurally in TKA remain uncertain. Dexamethasone has been shown to prolong block duration and reduce postoperative pain and opioid requirements, likely through anti-inflammatory and glucocorticoid-mediated mechanisms. Dexmedetomidine, an α2-adrenergic agonist, may further enhance analgesia and sensory block duration but has been associated with adverse effects such as sedation and bradycardia in susceptible patients. Comparative evidence between these agents in the specific context of combined iPACK and ACB is limited, and no clear consensus currently exists regarding their optimal use.
This randomized, double-blind, controlled clinical trial is designed to compare the efficacy and safety of perineural dexamethasone versus perineural dexmedetomidine as adjuvants to ropivacaine for ultrasound-guided iPACK and adductor canal blocks in elderly patients undergoing primary unilateral total knee arthroplasty. Eligible participants will be randomized into three parallel groups: ropivacaine alone (control), ropivacaine with perineural dexamethasone, or ropivacaine with perineural dexmedetomidine. All nerve blocks will be performed according to a standardized protocol by experienced anesthesiologists. Surgical, anesthetic, and postoperative analgesic management will be standardized across groups to minimize potential confounding factors. Participants, care providers, investigators, block practitioners, nursing staff, and outcome assessors will remain blinded to treatment allocation.
The primary outcome is cumulative opioid consumption during the first 24 postoperative hours, expressed as intravenous morphine equivalents. Secondary outcomes include pain intensity at rest and during mobilization, time to first rescue analgesia, motor-sparing profile, hemodynamic effects, quality of early recovery, and the incidence of adverse events such as postoperative nausea and vomiting, hypotension, bradycardia, and neurological symptoms. Functional recovery will additionally be evaluated using standardized physiotherapy milestones.
It is hypothesized that both perineural dexamethasone and dexmedetomidine will reduce postoperative opioid consumption compared with ropivacaine alone, and that one adjuvant may demonstrate superior analgesic efficacy or a more favorable safety profile. The findings of this study may provide clinically relevant evidence to guide the selection of perineural adjuvants for iPACK and adductor canal blocks in total knee arthroplasty, with the potential to improve pain control, accelerate rehabilitation, and reduce opioid exposure in an elderly, at-risk population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Ropivacaine 0.2% Injectable SolutionPatients receive ultrasound-guided iPACK block and adductor canal block (ACB) on the operative limb with ropivacaine 0.2% alone, without any perineural adjuvant. |
| Perineural Dexamethasone | Experimental | Drug: Dexamethasone 4mgPatients receive ultrasound-guided iPACK and ACB with ropivacaine 0.2% combined with perineural dexamethasone. |
| Perineural Dexmedetomidine | Experimental | Drug: DexmedetomidinePatients receive ultrasound-guided iPACK and ACB with ropivacaine 0.2% combined with perineural dexmedetomidine. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 65 years
- Scheduled for primary unilateral total knee arthroplasty under standardized anesthetic protocol
- ASA physical status I-III
- Ability to understand the study procedures and provide written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 0.2% Injectable SolutionUltrasound-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 | Control |
| Dexamethasone 4mgUltrasound-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 | Perineural Dexamethasone |
| DexmedetomidineUltrasound-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 | Drug | Perineural Dexmedetomidine |
Primary outcome
Cumulative opioid consumption in the first 24 hours after surgery
Time frame: 0-24 hours postoperatively
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.
12 secondary outcomes
Pain intensity at rest
Time frame: 6 hours postoperatively
Pain intensity at rest
Time frame: 12 hours postoperatively
Pain intensity at rest
Time frame: 24 hours postoperatively
Pain intensity at rest
Time frame: 48 hours postoperatively
Pain intensity during mobilization
Time frame: 24 hours postoperatively
Pain intensity during mobilization
Time frame: 48 hours postoperatively
Time to first rescue analgesia
Time frame: 0-48 hours postoperatively
Incidence of postoperative nausea and vomiting (PONV)
Time frame: 0-48 hours postoperatively
Motor function of the operated limb
Time frame: 6 hours postoperatively
Motor function of the operated limb
Time frame: 12 hours postoperatively
Motor function of the operated limb
Time frame: 24 hours postoperatively
Block-related and systemic adverse events
Time frame: Intraoperative and up to 48 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in the published article will be made available after de-identification. Data will include demographic characteristics, perioperative variables, intervention details, and primary and secondary outcomes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malgorzata Reysner, MD PhD study chair
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine 0.2% Injectable Solution, Dexamethasone 4mg and Dexmedetomidine in people with Knee Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative opioid consumption in the first 24 hours after surgery (time frame: 0-24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.