Effects of 10 Versus 20 mL Local Anesthetic for Popliteal Plexus Block on Opioid Consumption, Pai… (NCT06908837) | Clinical Trial Compass
CompletedPhase 4
Effects of 10 Versus 20 mL Local Anesthetic for Popliteal Plexus Block on Opioid Consumption, Pain, and Patient-Reported Outcomes After Total Knee Arthroplasty
Denmark120 participantsStarted 2025-04-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Scheduled to undergo primary total knee arthroplasty in spinal anesthesia.
* Ability to give their written informed consent after having fully understood the contents of the study.
* American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
Exclusion Criteria:
* Patients who cannot read or speak Danish.
* Patients who cannot operate or have access to a smartphone with internet connectivity (required for patient-reported outcome assessment).
* Patients with allergies or intolerance to the medicines used in the study.
* Patients with a consistent daily intake of opioids preoperatively.
* Patients who are dependent on walking aid devices preoperatively.
* Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment.
* BMI \> 40.
* Diagnosed with chronic neurodegenerative disorders.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total opioid consumption, expressed in oral morphine milligram equivalents (MME).
Timeframe: From T0 (end-of-surgery time) to T24 (24 hours after end-of-surgery time)