ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee … (NCT07677215) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Poland120 participantsStarted 2026-07-01
Plain-language summary
This prospective randomized controlled trial aims to compare the analgesic efficacy and safety of three adjuvant strategies for ultrasound-guided Adductor Canal Block (ACB) and iPACK block in patients undergoing elective total knee arthroplasty under spinal anesthesia. All participants will receive standardized spinal anesthesia with 0.5% ropivacaine combined with ACB and iPACK blocks using 0.2% ropivacaine. Patients will be randomized into one of three groups: standard ACB + iPACK without adjuvants, ACB + iPACK with intravenous dexamethasone 8 mg, or ACB + iPACK with intravenous dexamethasone 8 mg combined with perineural dexmedetomidine added to both regional blocks.
The primary outcome will be total postoperative opioid consumption during the first 48 hours after surgery expressed as intravenous morphine equivalents. Secondary outcomes will include pain intensity at rest and during movement, duration of analgesia, time to first rescue analgesia, quadriceps muscle strength, early mobilization, adverse events, inflammatory markers, and length of hospital stay.
Who can participate
Age range
60 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 60 and 100 years
* Scheduled for elective primary unilateral total knee arthroplasty
* American Society of Anesthesiologists (ASA) physical status I-III
* Ability to understand study procedures and provide written informed consent
* Eligibility for spinal anesthesia and ultrasound-guided regional anesthesia according to institutional standards
Exclusion Criteria:
* Known allergy or hypersensitivity to ropivacaine, dexamethasone, dexmedetomidine, or any study-related medication
* Contraindications to spinal anesthesia or peripheral nerve blocks
* Coagulation disorders or anticoagulant therapy preventing safe regional anesthesia
* Infection at the planned puncture site or systemic infection
* Severe neurological disorders affecting lower limb sensory or motor function
* Severe hepatic, renal, or uncontrolled cardiovascular disease
* Clinically significant bradycardia or advanced atrioventricular conduction abnormalities
* Chronic opioid use for more than 3 months before surgery
* Uncontrolled diabetes mellitus or contraindications to dexamethasone administration
* Inability or refusal to provide written informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total postoperative opioid consumption during the first 48 hours after surgery