The Efficacy of Local Infiltration Analgesia for Postoperative Pain Management After Total Knee A… (NCT04258241) | Clinical Trial Compass
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The Efficacy of Local Infiltration Analgesia for Postoperative Pain Management After Total Knee Arthroplasty
Lithuania80 participantsStarted 2020-03-06
Plain-language summary
This prospective, double-blinded, randomized controlled study evaluates the effects of peripheral nerve blocks with and without local infiltration analgesia for postoperative pain management after primary total knee arthroplasty. There are no any studies that show the demand for local infiltration analgesia when together peripheral nerve blocks are performed. Patients undergoing primary total knee arthroplasty will be randomly assigned to receive local infiltration analgesia with or without (placebo group) local anesthetic. All patients will receive peripheral nerve blocks for postoperative analgesia: femoral triangle and distal adductor canal blocks. Comparison of these two groups of patients will be based on the effects on postoperative pain control, the extent of motor blockade, the ability of early leg motion and ambulation, patients satisfaction rates over the time of clinical recovery.
Consequently, the investigators hypothesized that peripheral nerve blocks (femoral triangle and distal adductor canal blocks) with and without local infiltration analgesia provide similar postoperative pain relieving effects and the ability of early mobilization after total knee arthroplasty.
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:
* Patients undergoing primary unilateral total knee arthroplasty under spinal anaesthesia;
* Age 18 - 90 years;
* Patients conformed to American Society of Anaesthesiologists (ASA) physical status I-III in preoperative assessment;
* Ability to follow the study protocol.
Exclusion Criteria:
* Inability or refusal to follow the study protocol.
* American Society of Anesthesiologists (ASA) physical status classification of IV or higher.
* Coagulopathy.
* Pre-exiting lower extremity neuromuscular disorders.
* Local infection over injection site.
* Allergy or contraindications to the drugs used in the study (local anesthetics, NSAIDs, opioids).
* Chronic opioid use.
* Other type of anesthesia.
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
Changes in postoperative pain intensity and pain control: VAS pain scale
Timeframe: First 48 hours after primary total knee arthroplasty.