Effect of Low-dose Epidural Morphine Combined With Single-injection Femoral Nerve Block on Postoperative Analgesia in Patients After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Percent of patients with moderate to severe pain (Numeric Rating Scale pain score of 4 or higher)
研究概览
简要总结
Single femoral nerve blockade combined with patient-controlled intravenous analgesia are used for postoperative analgesia for patients after TKA in the hospital of the investigators. Although this method provides acceptable analgesia, the incidence of opioid-associated side effects is relatively high. Low-dose epidural morphine is commonly used in postoperative analgesia after cesarean section, and the effect of single dose morphine lasts more than 20 hours, with low incidences of itching, nausea, vomiting, and respiratory depression. The investigators hypothesize that, for patients undergoing TKA, the addition of low-dose epidural morphine to single femoral nerve block and intravenous opioids can improve the postoperative analgesia, reduce the consumption of intravenous opioids and decrease opioid-associated side effects.
详细描述
Total knee arthroplasty (TKA) is an important therapy for patients with serious knee osteoarthritis in order to improve quality of life and relieve pain. But a large number of patients who undergo this surgery experience moderate to severe postoperative pain. Previously, the investigators used single femoral nerve blockade combined with patient-controlled intravenous analgesia for postoperative analgesia for patients after TKA. Although this method provides acceptable analgesia, the incidence of opioid-associated side effects is relatively high. Low-dose epidural morphine is commonly used in postoperative analgesia after cesarean section, and the effect of single dose morphine lasts more than 20 hours, with low incidences of itching, nausea, vomiting, and respiratory depression. The investigators hypothesize that, for patients undergoing TKA, the addition of low-dose epidural morphine to single femoral nerve block and intravenous opioids can improve the postoperative analgesia, reduce the consumption of intravenous opioids and decrease opioid-associated side effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult patients (age of 18 years or older);
- •American Society of Anesthesiologists classification I-III;
- •Scheduled to undergo unilateral TKA under combined spinal and epidural anesthesia.
排除标准
- •Age higher than 90 years old;
- •Presence of any contraindication to neuraxial block or peripheral nerve block;
- •Continuous use of opioid analgesics during the last month;
- •Unable to understand Numeric Rating Scale for pain evaluation or existence of language barrier;
- •Severe renal insufficiency (requirement of renal replacement therapy);
- •History of asthma;
- •Recruited in another clinical trials.
研究组 & 干预措施
Epidural morphine
- Epidural morphine (2 mg morphine in 5 ml normal saline) is administered through the epidural catheter at the end of surgery.
- Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.
- Intravenous morphine analgesia is provided with a patient-controlled analgesia pump which is established with 100 ml of 0.5 mg/mL morphine, programmed to deliver a 2 ml bolus with a lockout interval of 8-10 min and a background infusion of 0.5 mL/h.
干预措施: Epidural morphine (Procedure)
Epidural morphine
- Epidural morphine (2 mg morphine in 5 ml normal saline) is administered through the epidural catheter at the end of surgery.
- Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.
- Intravenous morphine analgesia is provided with a patient-controlled analgesia pump which is established with 100 ml of 0.5 mg/mL morphine, programmed to deliver a 2 ml bolus with a lockout interval of 8-10 min and a background infusion of 0.5 mL/h.
干预措施: Single femoral nerve block (Procedure)
Epidural morphine
- Epidural morphine (2 mg morphine in 5 ml normal saline) is administered through the epidural catheter at the end of surgery.
- Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.
- Intravenous morphine analgesia is provided with a patient-controlled analgesia pump which is established with 100 ml of 0.5 mg/mL morphine, programmed to deliver a 2 ml bolus with a lockout interval of 8-10 min and a background infusion of 0.5 mL/h.
干预措施: Intravenous morphine analgesia (Drug)
Epidural placebo
- Epidural placebo (5 ml normal saline) is administered through the epidural catheter at the end of surgery.
- Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.
- Intravenous morphine analgesia is provided with a patient-controlled analgesia pump which is established with 100 ml of 0.5 mg/mL morphine, programmed to deliver a 2 ml bolus with a lockout interval of 8-10 min and a background infusion of 0.5 mL/h.
干预措施: Epidural placebo (Procedure)
Epidural placebo
- Epidural placebo (5 ml normal saline) is administered through the epidural catheter at the end of surgery.
- Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.
- Intravenous morphine analgesia is provided with a patient-controlled analgesia pump which is established with 100 ml of 0.5 mg/mL morphine, programmed to deliver a 2 ml bolus with a lockout interval of 8-10 min and a background infusion of 0.5 mL/h.
干预措施: Single femoral nerve block (Procedure)
Epidural placebo
- Epidural placebo (5 ml normal saline) is administered through the epidural catheter at the end of surgery.
- Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.
- Intravenous morphine analgesia is provided with a patient-controlled analgesia pump which is established with 100 ml of 0.5 mg/mL morphine, programmed to deliver a 2 ml bolus with a lockout interval of 8-10 min and a background infusion of 0.5 mL/h.
干预措施: Intravenous morphine analgesia (Drug)
结局指标
主要结局
Percent of patients with moderate to severe pain (Numeric Rating Scale pain score of 4 or higher)
时间窗: Until 48 hours after surgery.
Pain severity is evaluated with Numeric Rating Scale (NRS, an 11-point scale where 0 = no pain and 10 = the worst pain) both at rest and with movement.
次要结局
- NRS pain scores (at rest and with movement) at various timepoints after surgery(At 6, 12, 24, 36 and 48 hours after surgery.)
- Recovery of motor function of the lower limb from blockade(At the end of the surgery and at 0.5, 6, 12, 24, 36, 48 hours after surgery.)
- Time to begin functional exercise and ground walking(During hospital stay, up to 1 week after surgery.)
- Cumulative morphine consumption(Until 48 hours after surgery.)
- Patient's satisfaction with analgesia(At 48 hours after surgery.)
- The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index(At 30 days after surgery.)
- Length of stay in hospital after surgery(Until hospital discharge up to 30 days after surgery.)
- Incidence of postoperative complication(Until 30 days after surgery.)
- Quality of life (SF-12) at 30 days after surgery(At 30 days after surgery.)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Peking University First Hospital