Knee Osteoarthritis
Conditions
Brief 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.
Detailed description
Postoperative pain following total knee arthroplasty (TKA) remains a major clinical challenge and may negatively affect early mobilization, rehabilitation, patient satisfaction, and postoperative recovery. Inadequate pain control after TKA is associated with increased opioid consumption and opioid-related adverse events, including nausea, vomiting, sedation, urinary retention, respiratory depression, and postoperative delirium, particularly in elderly patients. Ultrasound-guided Adductor Canal Block (ACB) combined with iPACK (Infiltration between the Popliteal Artery and Capsule of the Knee) block has become an increasingly popular regional anesthesia strategy for TKA because it may provide effective analgesia while preserving quadriceps muscle strength and facilitating early mobilization. The ACB primarily targets the sensory innervation of the anterior and medial aspects of the knee, whereas the iPACK block supplements analgesia of the posterior knee capsule. Several adjuvant medications have been investigated to prolong the duration and improve the quality of peripheral nerve blocks. Intravenous dexamethasone is widely used as a perioperative analgesic adjunct and may prolong postoperative analgesia while also reducing postoperative nausea and vomiting. Perineural dexmedetomidine has been shown to prolong sensory blockade, improve analgesia quality, and reduce opioid requirements. However, the optimal combination of systemic and perineural adjuvants for ACB and iPACK blocks in TKA remains unclear. The aim of this prospective randomized controlled trial is to compare three perioperative analgesic strategies in patients undergoing elective primary unilateral total knee arthroplasty under spinal anesthesia: Standard ACB + iPACK without adjuvants, ACB + iPACK with intravenous dexamethasone 8 mg, ACB + iPACK with intravenous dexamethasone 8 mg combined with perineural dexmedetomidine. All participants will receive standardized spinal anesthesia with 0.5% ropivacaine (3-4 mL). Ultrasound-guided ACB and iPACK blocks will be performed using 20 mL of 0.2% ropivacaine for each block. In the dexmedetomidine group, 12.5 µg of dexmedetomidine will be added to each regional block. The primary endpoint of the study will be total postoperative opioid consumption during the first 48 postoperative hours expressed as intravenous morphine equivalents. Secondary endpoints will include postoperative pain scores at rest and during movement, time to first rescue analgesia, duration of analgesia, quadriceps muscle strength, early mobilization, opioid-related adverse events, dexmedetomidine-related adverse events such as bradycardia and hypotension, inflammatory markers, and length of hospital stay. The study hypothesis is that intravenous dexamethasone will improve postoperative analgesia compared with standard ACB + iPACK alone, while the addition of low-dose perineural dexmedetomidine will further prolong analgesia duration and reduce opioid consumption without significantly increasing adverse events or impairing postoperative mobilization.
Interventions
DRUGRopivacaine 0.2% Injectable Solution
Ropivacaine 0.2% used for ultrasound-guided ACB and iPACK blocks (20 mL per block).
DRUGDexamethasone
Intravenous dexamethasone 8 mg administered perioperatively.
DRUGDexmedetomidine
Perineural dexmedetomidine 12.5 μg added to each regional block (ACB and iPACK).
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total postoperative opioid consumption during the first 48 hours after surgery | 48 hours after surgery | Total postoperative opioid consumption will be recorded during the first 48 hours after total knee arthroplasty and converted to intravenous morphine milligram equivalents. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity at rest | 6 hours after surgery | Pain intensity at rest will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. |
| Pain intensity during movement assessed using the Numeric Rating Scale | 6 hours postoperatively | Pain intensity during movement will be assessed using the Numeric Rating Scale during active or passive knee movement, where 0 indicates no pain and 10 indicates the worst imaginable pain. |
| Time to first rescue analgesia | 48 hours after surgery | Time from the end of surgery to the first request for or administration of rescue analgesic medication. |
| Quadriceps muscle strength of the operated limb | 6 hours postoperatively | Quadriceps muscle strength of the operated limb will be assessed using a standardized motor strength scale. |
| Time to first postoperative mobilization | 48 hours postoperatively | Time from the end of surgery to the first successful mobilization with assistance, according to the institutional rehabilitation protocol. |
| Length of hospital stay | up to 7 days | Length of hospital stay will be defined as the number of days from surgery to hospital discharge. |
Countries
Poland
Contacts
CONTACTMalgorzata Reysner, MD PhD
CONTACTTomasz Reysner, MD PhD
STUDY_CHAIRMalgorzata Reysner, MD PhD
Poznan University of Medical Sciences
STUDY_DIRECTORMichał Borys, MD PhD
The John Paul II Catholic University of Lublin
Outcome results
None listed