Postoperative Pain and Analgesic Consumption in Patients Undergoing Total Knee Arthroplasty Under General Anesthesia With Peripheral Nerve Block Versus Spinal Anesthesia With Peripheral Nerve Block
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Tomas Bata Hospital, Czech Republic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity
概览
简要总结
This prospective observational study evaluates postoperative pain intensity and analgesic consumption in patients undergoing total knee arthroplasty (TKA) under different anesthesia techniques. Patients receive either general anesthesia with peripheral nerve block, spinal anesthesia with peripheral nerve block, spinal anesthesia alone, or general anesthesia with an epidural catheter. Pain scores (NRS), analgesic use, adverse effects, patient satisfaction, and the need for therapeutic interventions are assessed during the first 48 hours after surgery. The study aims to identify differences in postoperative pain control and factors associated with hypotension and other complications.
详细描述
This prospective, monocentric observational study evaluates postoperative pain intensity and analgesic consumption in adult patients undergoing primary total knee arthroplasty (TKA). The study focuses on anesthesia techniques routinely used in clinical practice, including general anesthesia with peripheral nerve block, general anesthesia with an epidural catheter, spinal anesthesia with peripheral nerve block, and spinal anesthesia alone.
The primary methodological aim is to compare postoperative pain trajectories (NRS) and total analgesic use during the first 48 hours after surgery across anesthesia strategies. Secondary observations include adverse effects related to analgesia, patient satisfaction, and the need for therapeutic interventions such as fluid administration, vasopressors, antiemetics, or adjustments in analgesic regimen.
Independent variables include type of anesthesia, ASA physical status, age, sex, BMI, type of peripheral nerve block, and duration of surgery. Dependent variables include postoperative pain scores, analgesic consumption, adverse events, and patient-reported satisfaction.
The study is designed to identify clinically relevant differences in postoperative pain control and to explore factors associated with hypotension and other perioperative complications. Findings may support optimization of perioperative analgesia and guide clinical decision-making in anesthesia management for TKA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-100 years
- •Primary total knee arthroplasty (TKA)
- •ASA physical status I-III
- •Glasgow Coma Scale (GCS) score of 15
- •Ability to understand study procedures and provide informed consent
- •Ability to cooperate during pre-anesthetic evaluation
- •No severe sensory impairment (e.g., blindness, deafness)
排除标准
- •Revision or reoperation of TKA
- •ASA score IV or higher
- •Refusal to participate or inability to provide informed consent
- •Limited legal capacity
- •Active psychiatric disorder
- •Chronic use of strong opioid analgesics
- •Neurological disease affecting pain perception or cooperation
- •Cognitive impairment or language barrier preventing questionnaire completion
- •Use of anesthesia techniques other than GA + PNB or SA + PNB (e.g., epidural anesthesia, local infiltration without PNB)
研究组 & 干预措施
Spinal Anesthesia (SA)
Patients receiving spinal anesthesia alone without an additional peripheral nerve block. Spinal anesthesia provides sensory and motor blockade of the lower body during surgery. This group allows evaluation of postoperative pain and analgesic requirements in patients managed with spinal anesthesia as the sole regional technique.
General Anesthesia + Peripheral Nerve Block (CA + PNB)
Patients undergoing total knee arthroplasty under general anesthesia combined with a peripheral nerve block. General anesthesia is induced using intravenous and inhalational agents. A peripheral nerve block (most commonly femoral or saphenous) is administered preoperatively to reduce postoperative pain and opioid requirements. This group represents a commonly used multimodal analgesic approach in routine clinical practice.
General Anesthesia + Epidural Catheter (CA + EDA)
Patients undergoing total knee arthroplasty under general anesthesia with an epidural catheter placed for intraoperative and postoperative analgesia. General anesthesia is induced using intravenous and inhalational agents. The epidural catheter allows continuous administration of analgesics and individualized dose adjustment to maintain postoperative pain control. This group represents a commonly used technique for providing extended regional analgesia following TKA.
Spinal Anesthesia + Peripheral Nerve Block (SA + PNB)
Patients undergoing total knee arthroplasty under spinal anesthesia supplemented with a peripheral nerve block. Spinal anesthesia is administered into the subarachnoid space to provide intraoperative analgesia. A peripheral nerve block (femoral or saphenous) is added to enhance postoperative pain control and reduce the need for systemic analgesics. This combination represents a commonly used multimodal analgesic strategy.
结局指标
主要结局
Postoperative pain intensity
时间窗: 6 hours, 24 hours, and 48 hours after surgery
Pain intensity will be assessed using the Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) at predefined postoperative intervals. Both scales range from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent worse pain intensity.
次要结局
- Number of participants requiring therapeutic interventions(Up to 48 hours after surgery.)
- Analgesic consumption(First 48 hours after surgery)
- Adverse effects(First 48 hours after surgery)
- Patient satisfaction(48 hours after surgery)
- Length of hospital stay(From the day of surgery (Day 0) through hospital discharge (typically 3-14 days).)
研究者
Klára Nekvindová
Clinical Research Lead, omas Bata Hospital
Tomas Bata Hospital, Czech Republic