ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-100
SponsorPoznan University of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ropivacaine 0.2% Injectable Solution

    Drug

    Ropivacaine 0.2% used for ultrasound-guided ACB and iPACK blocks (20 mL per block).

  • Dexamethasone

    Drug

    Intravenous dexamethasone 8 mg administered perioperatively.

  • Dexmedetomidine

    Drug

    Perineural dexmedetomidine 12.5 μg added to each regional block (ACB and iPACK).

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: ACB + iPACK Without AdjuvantsActive comparator 1 intervention
Group B: ACB + iPACK With Intravenous DexamethasoneExperimental treatment 1 intervention
Group C: ACB + iPACK With Intravenous Dexamethasone and Perineural DexmedetomidineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total postoperative opioid consumption during the first 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.

Time frame
48 hours after surgery

Secondary outcomes

1

Pain intensity at rest

Pain intensity at rest will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.

Time frame
6 hours after surgery
2

Pain intensity at rest

Pain intensity at rest will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.

Time frame
12 hours after surgery
3

Pain intensity at rest

Pain intensity at rest will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.

Time frame
24 hours after surgery
4

Pain intensity at rest

Pain intensity at rest will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.

Time frame
48 hours after surgery

Other outcomes

Sponsors and contacts

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