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

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Forrás: NCT07677215: ki vehet részt

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Contact the study team: see the registry record → Contacts and Locations

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A vizsgálat adatai

Ki végzi
Poznan University of Medical Sciences
Azonosító
NCT07677215
A regiszteradat frissítve
2026. november 5.
Eredeti leírás
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.A teljes eredeti leírásKevesebb

Comparison of the Efficacy and Safety of Three Adjuvant Strategies for ACB and iPACK Blocks in Patients Undergoing Elective Total Knee Arthroplasty: A Prospective, Randomized Clinical 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.

Bevonási feltételek: 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.

Kizáró feltételek: Chronic opioid use for more than 3 months before surgery; Known allergy or hypersensitivity to ropivacaine, dexamethasone, dexmedetomidine, or any study-related medication; 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; Uncontrolled diabetes mellitus or contraindications to dexamethasone administration; Contraindications to spinal anesthesia or peripheral nerve blocks; Clinically significant bradycardia or advanced atrioventricular conduction abnormalities; Inability or refusal to provide written informed consent.

ClinicalTrials.gov NCT07677215