NCT07629388尚未招募不适用
Comparative Study Assessing the Efficacy of a Combined Distal Femoral Nerve Block for Postoperative Analgesia Following Total Knee Arthroplasty (TKA)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to see whether a combined distal femoral nerve block improves pain relief after total knee replacement in adults having planned surgery. The main questions it aims to answer are:
- Does the combined distal femoral nerve block reduce the amount of opioid needed in the post-anesthesia recovery room?
- Does it preserve quadriceps muscle strength while improving postoperative pain control?
Researchers will compare the combined distal femoral nerve block to a saphenous nerve block alone to see if the combined block provides better analgesia without reducing leg strength.
Participants will:
- Receive either the combined distal femoral nerve block or the saphenous nerve block alone before surgery.
- Also receive standard multimodal pain management, including anesthesia, surgical site infiltration, and postoperative pain medications.
- Be assessed for pain, opioid use, nausea and vomiting, quadriceps strength, time to first standing, hospital stay length, and patient satisfaction from surgery until discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged over 18 years.
- •Scheduled for total knee arthroplasty with multimodal analgesia.
- •Affiliated with or benefiting from a social security system.
- •Able to understand the study information and provide written informed consent.
排除标准
- •Emergency surgery.
- •Weight under 50 kg.
- •Body mass index over 40 kg/m².
- •Contraindication to nefopam, non-steroidal anti-inflammatory drugs, local anesthetics, or morphine.
- •Preoperative opioid use.
- •Antidepressant or gabapentinoid treatment.
- •Other planned surgical or medical procedures during the study period.
- •Participation in another clinical trial, or currently in an exclusion period from another trial.
- •Inability to understand study information for linguistic, psychological, cognitive, or literacy reasons.
- •Pregnancy, possible pregnancy without effective contraception, or breastfeeding.
- •Protected adults, including those under guardianship, curatorship, legal protection, detention, or otherwise unable to give informed consent.
研究者
研究点 (1)
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