Addition Of Genicular Nerve Block To Femoral Nerve Block Improves Early Postoperative Analgesia After Total Knee Replacement: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Title: 24-hour postoperative epidural analgesic consumption.Description: The total dose (in ml) of epidural analgesic consumed by the patient via the patient-controlled analgesia (PCA) device within the first 24 hours following total knee arthroplasty su
概览
简要总结
Total knee arthroplasty (TKA) is a common orthopedic procedure in which effective postoperative pain management is important for early mobilization and rehabilitation. Various regional anesthesia techniques are used as part of multimodal analgesia protocols to improve postoperative pain control. Genicular nerve block has recently been introduced as a potential motor-sparing technique that may enhance postoperative analgesia when used alone or in combination with other regional blocks.
The aim of this randomized controlled study is to evaluate whether the addition of ultrasound-guided genicular nerve block to femoral nerve block improves early postoperative analgesia in patients undergoing primary unilateral total knee arthroplasty under combined spinal-epidural anesthesia.
A total of 80 patients aged 18-80 years scheduled for elective primary unilateral TKA will be included and randomly assigned to two groups using sealed envelopes. One group will receive femoral nerve block alone (Group F), while the other group will receive femoral nerve block combined with genicular nerve block (Group FG). Postoperative pain scores using the visual analog scale (VAS), epidural patient-controlled analgesia consumption during the first 24 hours, and the time to additional analgesic requirement will be recorded and compared between the groups.
详细描述
The aim of this prospective, randomized controlled study is to evaluate whether the addition of an ultrasound-guided (USG) genicular nerve block (GNB) to a standard femoral nerve block (FNB) improves postoperative analgesia compared with FNB alone in patients undergoing primary unilateral total knee arthroplasty (TKA).
All patients will undergo surgery under combined spinal-epidural anesthesia. After administration of the spinal block and placement of the epidural catheter, participants will be randomly assigned to one of two groups.
Group F (Control): Participants will receive an ultrasound-guided femoral nerve block using 20 mL of 0.25% bupivacaine.
Group FG (Intervention): Participants will receive an ultrasound-guided femoral nerve block (20 mL of 0.25% bupivacaine) combined with a four-point ultrasound-guided genicular nerve block targeting the superomedial, superolateral, inferomedial, and inferolateral genicular nerve branches. Each branch will receive 5 mL of 0.25% bupivacaine.
Postoperative analgesia will be standardized in both groups using an epidural patient-controlled analgesia (PCA) device operating in bolus-only mode (5 mL bolus, 20-minute lockout interval) containing fentanyl (3 µg/mL) and bupivacaine (0.5 mg/mL).
The primary outcome measure will be the total volume of epidural analgesic solution consumed during the first 24 hours after surgery. Secondary outcome measures will include postoperative pain intensity assessed using the Visual Analog Scale (VAS) at predefined time points (0, 2, 8, 12, and 24 hours), time to first additional analgesic requirement, and the incidence of postoperative side effects such as nausea or dizziness.
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
- None
盲法说明
Based on your source, you should select the roles that were blinded. If only the outcomes assessor or patients were blinded, check the relevant boxes.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18-80 years of age, both sexes.
- •Patients scheduled for primary unilateral total knee arthroplasty (TKA).
- •ASA physical status classification I, II, and III.
- •Ability to provide written informed consent.
排除标准
- •Patients unwilling to participate.
- •ASA class IV or V.
- •Patients undergoing revision TKA.
- •Infection or neuropathy at the block site.
- •Coagulopathy or current anticoagulant therapy.
- •Severe systemic diseases (cardiac, pulmonary, hepatic, or renal).
- •Diabetic neuropathy.
- •Previous cerebrovascular accidents with motor or sensory deficits.
- •Neuropsychiatric disorders or cognitive impairment affecting scale interpretation.
- •Chronic analgesic use (NSAIDs or opioids).
研究组 & 干预措施
Group F (Femoral Block Only)
Patients in this group received an ultrasound-guided femoral nerve block administered with 20 ml of 0.25% bupivacaine. All patients also received standardized multimodal analgesia, including epidural patient-controlled analgesia (PCA)
干预措施: Ultrasound-guided Femoral Nerve Block (Procedure)
Group FG (Combined Block)
Patients in this group received a combination of an ultrasound-guided femoral nerve block (20 ml of 0.25% bupivacaine) and an ultrasound-guided genicular nerve block. The genicular nerve block targeted the superomedial, superolateral, inferomedial, and inferolateral genicular nerves, with 5 ml of 0.25% bupivacaine administered at each site. All patients also received standardized multimodal analgesia, including epidural patient-controlled analgesia (PCA).
干预措施: ltrasound-guided Genicular Nerve Block (Procedure)
结局指标
主要结局
Title: 24-hour postoperative epidural analgesic consumption.Description: The total dose (in ml) of epidural analgesic consumed by the patient via the patient-controlled analgesia (PCA) device within the first 24 hours following total knee arthroplasty su
时间窗: First 24 hours following the total knee arthroplasty (TKA) procedure
Total volume (in ml) of the epidural analgesic solution (fentanyl and bupivacaine) consumed by the patient via the patient-controlled analgesia (PCA) device within the first 24 hours post-surgery.
24-hour postoperative epidural analgesic consumption.
时间窗: First 24 hours following the total knee arthroplasty (TKA) procedure.
Total volume (in ml) of epidural analgesic solution (fentanyl and bupivacaine) consumed by the patient via the patient-controlled analgesia (PCA) device within the first 24 hours post-surgery
次要结局
未报告次要终点
研究者
semih başkan
Principal Investigator
Ankara City Hospital Bilkent