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Effects of 10 vs. 20 mL Local Anesthetic for Popliteal Plexus Block on Opioid Consumption, Pain, and Patient-Reported Outcomes after Total Knee Arthroplasty - a randomized, controlled, blinded study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520204-26-00
Enrollment
120
Registered
2025-03-17
Start date
2025-03-30
Completion date
2025-11-26
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain after Total Knee Arthroplasty

Brief summary

Total opioid consumption from end-of-surgery time (T0) until 24 hours postoperatively (T24), expressed in oral morphine milligram equivalents (MME).

Detailed description

Frequency of patients with no opioid consumption from T0 until T24., Pain in the operated knee at rest, scored by NRS, obtained at the timepoints: Preoperative, at 6 hours (+/- 1 hour) after end-of-surgery time (T6), and at T24., Pain in the operated knee during a 10-meter walk with crutches, scored by NRS, obtained at the time points: Preoperative, T6 and at T24., Frequency of patients unable to walk 10 meters with crutches at T6., Frequency of Manual Muscle Test results < Grade 3 in evaluations of dorsiflexion and plantarflexion of the ankle and knee extension, examined at T6., Patient reported outcome measure of Quality of Recovery 15 at T24.

Interventions

DRUGBUPIVACAINE

Sponsors

Region Midtjylland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Total opioid consumption from end-of-surgery time (T0) until 24 hours postoperatively (T24), expressed in oral morphine milligram equivalents (MME).

Secondary

MeasureTime frame
Frequency of patients with no opioid consumption from T0 until T24., Pain in the operated knee at rest, scored by NRS, obtained at the timepoints: Preoperative, at 6 hours (+/- 1 hour) after end-of-surgery time (T6), and at T24., Pain in the operated knee during a 10-meter walk with crutches, scored by NRS, obtained at the time points: Preoperative, T6 and at T24., Frequency of patients unable to walk 10 meters with crutches at T6., Frequency of Manual Muscle Test results < Grade 3 in evaluations of dorsiflexion and plantarflexion of the ankle and knee extension, examined at T6., Patient reported outcome measure of Quality of Recovery 15 at T24.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 20, 2026