Do Peripheral Nerve Blocks When Used as Part of a Multimodal Regimen Inclusive on Intrathecal Morphine Improve Analgesia After Unilateral Total Knee Arthroplasty? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Postoperative parenteral morphine consumption
研究概览
简要总结
The purpose of this study is to determine whether intrathecal morphine (ITM) alone or its combination with peripheral nerve blocks (PNB) provides better analgesia for patients undergoing total knee arthroplasty (TKA).
详细描述
Total knee arthroplasty (TKA) surgery is associated with severe pain. The success of knee rehabilitation following surgery depends largely on adequate pain control that permits early physical therapy. Postoperative modern analgesic recommendations specific to TKA propose either spinal block with intrathecal morphine (ITM) or a combination of general anesthesia with single shot femoral nerve block (SFNB). Femoral nerve block (FNB) too has proven analgesic advantages in TKA surgery. However, we do not know if the combination of the two analgesic techniques, ITM and peripheral nerve blocks (PNB), provides superior analgesia to ITM alone.
Thus, this study aims to determine whether ITM alone or its combination with PNB provides better analgesia for patients undergoing total knee arthroplasty (TKA).
Eligible patients undergoing unilateral TKA under spinal anesthesia consenting to a multimodal analgesic regimen inclusive of ITM, FNB, and SNB will be recruited. All patients will receive spinal with intrathecal morphine. Patients will be randomly assigned using a computer generated table of random numbers to receive either spinal with intrathecal morphine (morphine group), a combination of intrathecal morphine and femoral nerve block (morphine-femoral group), or a combination of intrathecal morphine and femoral nerve block as well as sciatic nerve block (morphine-femoral-sciatic group).
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •ASA I-III patients undergoing unilateral TKA under spinal anesthesia and nerve blocks
- •Ages 18-80
- •BMI ≤ 38 kg/m2
排除标准
- •BMI > 38 kg/m2
- •chronic pain disorders
- •Significant pre-existing neurological deficits or peripheral neuropathy affecting the lower extremity
- •abuse of drugs or alcohol
- •Contraindication to a component of multi-modal analgesia
- •Contraindication to spinal anesthesia or failure to institute spinal anesthesia after performing femoral and sciatic blocks
- •Bilateral TKA surgeries
- •History of significant psychiatric conditions that may affect patient assessment
- •Pregnancy
- •Moderate to severe obstructive sleep apnea.
- •Previous adverse reactions resulting from intrathecal opioids (respiratory depression, urinary retention, severe pruritis, severe nausea or vomiting, severe sedation)
- •inability to provide informed consent.
研究组 & 干预措施
Morphine group
Patients will receive a combined spinal epidural anesthesia technique with intrathecal morphine
干预措施: Combined spinal epidural anesthesia technique with intrathecal morphine (Drug)
Morphine-femoral group
Patients will receive a combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block
干预措施: A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block (Drug)
Morphine-femoral-sciatic group
Patients will receive a combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block
干预措施: A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block (Drug)
结局指标
主要结局
Postoperative parenteral morphine consumption
时间窗: first 24 hours post-operation
次要结局
- Visual analogue pain scores (VAS) in anterior and posterior knee(within 24-48 hours after surgery)
- Severity of pain in anterior and posterior knee(1 week postoperatively)
- Time to first IV PCA bolus(within first 12 hours)
- Total IV PCA consumption upon discontinuation of PCA(24-48 hours after surgery)
- Side effects(within 24 hours after surgery)
- Patient satisfaction with pain control(24-48 hours after surgery)
- complications(1 month after surgery)
研究者
Ghassan Kanazi
Professor and Chairman
American University of Beirut Medical Center