Comparing two additives to nerve blocks to reduce pain after knee replacement
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
NA · Poznan University of Medical Sciences · NCT07386600
This study will test whether adding dexamethasone or dexmedetomidine to the local anesthetic used for iPACK and adductor canal blocks helps older adults need less opioid pain medicine after knee replacement.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 65 Years to 100 Years |
| Sex | All |
| Sponsor | Poznan University of Medical Sciences (other) |
| Locations | 1 site (Poznan) |
| Trial ID | NCT07386600 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, three-arm trial in patients aged 65 and older undergoing primary unilateral total knee arthroplasty. Participants receive ultrasound-guided iPACK and adductor canal blocks with ropivacaine alone, ropivacaine plus perineural dexamethasone, or ropivacaine plus perineural dexmedetomidine. The primary outcome is postoperative opioid consumption; secondary outcomes include pain scores at rest and with movement, time to first rescue analgesia, early functional recovery, and safety (including sedation and bradycardia). The trial is conducted at Poznan University of Medical Sciences under a standardized anesthetic protocol.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 or older scheduled for primary unilateral total knee arthroplasty who can consent and have no contraindications to peripheral nerve blocks or to the study drugs.
Not a fit: Patients on high-dose chronic opioids, with severe hepatic or renal failure, significant cognitive impairment, or contraindications to nerve blocks are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative opioid use and improve pain control after knee replacement, helping patients mobilize earlier.
How similar studies have performed: Previous studies have shown that perineural dexamethasone and dexmedetomidine can prolong peripheral nerve blocks and reduce postoperative pain, but direct head-to-head comparisons specifically in TKA are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Poznan
- Poznan University of Medical Sciences — Poznan, Poland (RECRUITING)
Study contacts
- Study coordinator: Malgorzata Reysner, MD PhD
- Email: mreysner@ump.edu.pl
- Phone: +48 61 873 83 03
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Knee Osteoarthritis