Comparison of Intraarticular Application of Local Anesthetics Versus Peripheral Regional Anesthesia in Patients With Total Arthroplasty of the Knee (K-TEP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity at 48 Hours (VAS Score)
研究概览
简要总结
Why are we doing this study? People who have knee replacement surgery often feel pain afterward. Doctors use different methods to control this pain. One method is an injection of numbing medicine directly into the knee during surgery, called local infiltration analgesia (LIA). Another method uses a thin tube (catheter) placed near nerves in the leg to continuously deliver numbing medicine, called a nerve block. This study compares these two pain control methods after knee replacement surgery, to find out whether the injection method (LIA) works at least as well as the nerve block method for controlling pain.
Who can take part in this study? Adults aged 18 to 90 years who need a first-time (primary) knee replacement because of knee arthritis can take part. Participants must be able to walk before surgery, be in generally stable health, and be able to give informed consent. People with a knee injury (rather than arthritis), people who use a wheelchair, and people unable to give consent were not included.
What happens during this study? 78 participants were randomly assigned, like a coin flip, to receive either the injection into the knee (LIA) or the nerve block through a catheter for pain relief after surgery. Both groups also received the same standard pain medicines by mouth or vein as needed. Researchers measured pain levels using a 0-10 pain scale before surgery and at 24, 48, 72, and 96 hours afterward. They also measured knee movement (range of motion), how much extra pain medicine was needed, and how satisfied participants were with their pain control. The study took place at one hospital, the Elisabethinen Hospital in Klagenfurt, Austria, between June 2025 and January 2026.
详细描述
This is a prospective, randomized, open-label, controlled non-inferiority trial conducted at a single center (Department of Orthopedics and Traumatology, Elisabethinen Krankenhaus Klagenfurt). The trial compares two established postoperative analgesic techniques for primary total knee arthroplasty (TKA): local infiltration analgesia (LIA) versus continuous peripheral regional anesthesia via femoral and sciatic nerve block. Both techniques are already in routine clinical use; this trial was designed to determine which approach provides superior or at least non-inferior pain control at this institution.
Hypothesis
The investigators hypothesized that LIA is not inferior to peripheral regional anesthesia with regard to postoperative pain control, measured on a 100 mm Visual Analogue Scale (VAS) 48 hours after surgery (VAS48). A non-inferiority margin of 10 mm was pre-specified, based on published minimal clinically important difference (MCID) estimates for postoperative pain on the VAS (approximately 8-40 mm across systematic reviews, with common MCID estimates near 10 mm). Non-inferiority is concluded if the upper limit of the one-sided 97.5% confidence interval of the mean difference (LIA minus nerve block) is below this margin.
Sample size: Assuming a between-group mean difference of 0 mm and a combined standard deviation of 15 mm (derived from comparable published TKA analgesia trials), a sample of 37 patients per group provides 80% power (one-sided alpha = 0.025) to demonstrate non-inferiority. Accounting for an anticipated 5% drop-out rate, 78 patients were enrolled in total.
Randomization and blinding: Patients were allocated 1:1 to the LIA or nerve block group using the institutional randomization tool of the Medical University of Graz. The trial is open-label; blinding of the anesthetic technique was not feasible given the distinct procedural nature of the two interventions.
In addition to the primary pain endpoint, the trial captures postoperative opioid consumption, range of motion (knee flexion, measured by goniometer) during early mobilization, and overall patient satisfaction with perioperative care and pain management, assessed using a standardized questionnaire (Anästhesiologischer Nachbefragungsbogen, ANP) at 24 and 96 hours postoperatively. Data were collected between June 2025 and January 2026. No external funding or commercial sponsorship was involved; statistical analysis was performed by the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 90 years
- •Primary or secondary knee osteoarthritis (gonarthrosis)
- •Scheduled for elective primary total knee arthroplasty (cruciate-retaining implant)
- •Ambulatory prior to surgery (able to walk unassisted)
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Able to provide written informed consent
排除标准
- •Post-traumatic knee arthropathy (trauma-related indication for surgery)
- •Wheelchair use / inability to ambulate preoperatively
- •ASA physical status IV or higher
- •Lack of capacity to provide informed consent (e.g., legal guardianship/procurator required)
- •Planned unicompartmental (hemi-) knee arthroplasty or revision surgery
- •Known allergy or contraindication to the study medications (ropivacaine, ketorolac, or epinephrine)
研究组 & 干预措施
Local Infiltration Analgesia (LIA)
Participants received intraoperative periarticular local infiltration analgesia consisting of 200 mL ropivacaine (2 mg/mL, first 50 mL discarded), 30 mg ketorolac, and 0.5 mg epinephrine, injected during total knee arthroplasty. All participants additionally received the standardized postoperative oral/intravenous analgesic regimen (diclofenac, hydromorphone, metamizole, paracetamol as needed).
干预措施: Local Infiltration Analgesia (Ropivacaine, Ketorolac, Epinephrine) (Drug)
Peripheral Regional Anesthesia (Femoral and Sciatic Nerve Block)
Participants received continuous femoral and sciatic nerve block via perineural catheters. An initial local anesthetic bolus was followed by continuous ropivacaine 0.2% infusion for 48 hours postoperatively (5 mL/h for the first 24 hours, then reduced to 3 mL/h), with patient-controlled boluses available. The same standardized postoperative oral/intravenous analgesic regimen as the LIA group was administered.
干预措施: Continuous Femoral and Sciatic Nerve Block (Ropivacaine) (Drug)
结局指标
主要结局
Postoperative Pain Intensity at 48 Hours (VAS Score)
时间窗: 8 hours postoperatively
Pain intensity measured with the Visual Analogue Scale (VAS), assessed at rest, at night, and during mobilization 48 hours after total knee arthroplasty. This measure was used to test non-inferiority of LIA versus peripheral regional (femoral/sciatic nerve block) anesthesia against a pre-specified non-inferiority margin.
Postoperative Pain Intensity at 48 Hours (VAS Score)
时间窗: 48 hours postoperatively
Pain intensity measured with the Visual Analogue Scale (VAS), a 0-10 point scale where 0 indicates no pain and 10 indicates the worst pain imaginable (higher scores indicate worse pain), assessed at rest, at night, and during mobilization 48 hours after total knee arthroplasty. This measure was used to test non-inferiority of LIA versus peripheral regional (femoral/sciatic nerve block) anesthesia against a pre-specified non-inferiority margin.
次要结局
未报告次要终点
研究者
Christopher Male
Dr. Christopher Male ,Doctoral Candidate, Department of Sustainable Health Research, Medical University of Graz
Elisabethinen Hospital