Ultrasound-guided Block of the Saphenous Nerve and Obturator Nerve, Posterior Branch, for Postoperative Pain Management After Ambulatory Knee Arthroscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain on knee flexion
研究概览
简要总结
In this study, we wish to investigate the effect of ultrasound (US) -guided block of the saphenous nerve (SN) and the posterior branch of the obturator nerve (ONP) on postoperative pain and the use of opioids (morphine-like pain medicine) in the first 24 hours following ambulatory knee arthroscopy.
We wish to investigate the analgesic effect of these two blocks compared to placebo (injection of local anesthetic with known pain blocking properties compared with injection of a saline solution), when used as a supplement to conventional oral analgesics.
We hypothesize that patients receiving the active treatment may experience less pain during the first 24 hours after their operation than patients receiving the placebo treatment, and possibly require less opioid analgesics, experience less opioid related side effects and have a higher function level in this period than patients receiving the placebo treatment.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Planned ambulatory knee arthroscopy, except cruciate ligament surgery
- •American Society of Anesthesiologists (ASA) class 1-3
排除标准
- •Cannot cooperate
- •Do not speak or understand Danish
- •Daily use of opioid analgesics
- •Allergy towards any of the drugs used in the investigation
- •Medicine abuse (at the investigators discretion)
- •Alcohol abuse, as defined by the National Board of Health
- •General anesthesia contraindicated, or the patient wants spinal anesthesia
- •Visualization of necessary structures by ultrasound not possible, or block not possible for other technical reasons
研究组 & 干预措施
Block arm
Ultrasound guided block of the SN and ONP with 7.5 ml of Ropivacaine 7.5 mg/ml injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.
干预措施: Block of the SN and ONP (Procedure)
Block arm
Ultrasound guided block of the SN and ONP with 7.5 ml of Ropivacaine 7.5 mg/ml injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.
干预措施: Paracetamol (Drug)
Block arm
Ultrasound guided block of the SN and ONP with 7.5 ml of Ropivacaine 7.5 mg/ml injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.
干预措施: Morphine (Drug)
Block arm
Ultrasound guided block of the SN and ONP with 7.5 ml of Ropivacaine 7.5 mg/ml injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.
干预措施: Ondansetron (Drug)
Block arm
Ultrasound guided block of the SN and ONP with 7.5 ml of Ropivacaine 7.5 mg/ml injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.
干预措施: Metoclopramide (Drug)
Placebo arm
Ultrasound guided placebo block of the SN and ONP with 7.5 ml of isotonic saline solution injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.
干预措施: Placebo block (Procedure)
Placebo arm
Ultrasound guided placebo block of the SN and ONP with 7.5 ml of isotonic saline solution injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.
干预措施: Paracetamol (Drug)
Placebo arm
Ultrasound guided placebo block of the SN and ONP with 7.5 ml of isotonic saline solution injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.
干预措施: Morphine (Drug)
Placebo arm
Ultrasound guided placebo block of the SN and ONP with 7.5 ml of isotonic saline solution injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.
干预措施: Ondansetron (Drug)
Placebo arm
Ultrasound guided placebo block of the SN and ONP with 7.5 ml of isotonic saline solution injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.
干预措施: Metoclopramide (Drug)
结局指标
主要结局
Pain on knee flexion
时间窗: 24 hours postoperatively
VRS (Verbal Rating Scale) score 0-10 on active flexion of the knee to 45 degrees, measured at 0, ½, 1, 2, 3, 4, 6, 8, 12 and 24 hours postoperatively and analyzed by area under curve (AUC) analysis.
次要结局
- Use of antiemetics(24 hours)
- PACU length of stay(24 hours)
- Nausea(24 hours postoperatively)
- Function level: Short form (SF) -8(24 hours)
- Pain at rest(24 hours postoperatively)
- Time to opioid intake(24 hours postoperatively)
- Total opioid intake(24 hours)
- Vomiting(24 hours)
- Function level: Barthel Index/100(24 hours)
研究者
Jens Borglum Neimann
MD, PhD, MBA
Bispebjerg Hospital