Clinical Trial

Effects of 10 Versus 20 mL Local Anesthetic for Popliteal Plexus Block on Opioid Consumption, Pain, and Patient-Reported Outcomes After Total Knee Arthroplasty

Completed Phase 4
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Summary
This trial aims to assess the analgesic effect of Popliteal Plexus Block (PPB) with 10 mL versus 20 mL of Bupivacain 5 mg/mL, when applied as an adjunct treatment to a multimodal analgesic regimen following primary total knee arthroplasty. We hypothesize that PPB with 20 mL of local anesthetic reduces 24-hour postoperative opioid consumption (= primary outcome) compared to 10 mL after TKA. Secondary outcome include * the frequency of 24-hour opioid-free analgesia * pain intensity at rest and during mobilization * Manual Muscle Tests and ability to mobilize with crutches six hours after end-of-surgery * and patients reported outcomes using the Quality of Recovery 15 survey 24 hours after end-of-surgery. Participant will: * undergo primary total knee arthroplasty in spinal anesthesia. * recieve a PPB with either 10 mL of Bupivacaine or 20 mL. * recieve a multimodal analgesic regime including a Femoral Triangle Block. * Have 10 scored morphine tablets available for self-administration within the first 24 postoperative hours after end-of-surgery. * be examined by a physiotherapist 6 hours (±1 hour) after end-of-surgery to assess pain scores, manual muscle testing of ankle and knee function, and the ability to mobilize with crutches. * complete a survey 24 hours after end-of-surgery to assess self-administered morphine intake, pain scores, and Quality of Recovery-15.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-04-02; most recent amendment 2026-01-20.
Status change: Enrolling by Invitation → Completed 2026-01-20
Status change: Recruiting → Enrolling by Invitation 2025-04-08
Trial Details
NCT Number NCT06908837
Lead Sponsor Regionshospitalet Silkeborg
Conditions Total Knee Arthroplasty, Regional Anesthesia, Multimodal Analgesic Approach, Postoperative Opioid-related Complications
Enrollment 120 participants
Start Date 2025-04-07
Primary Completion 2025-11-26 (estimated)
Study Completion 2025-11-26 (estimated)
Updated on ClinicalTrials.gov 2026-01-22