跳至主要内容
临床试验/NCT04153396
NCT04153396已完成4 期

Preemptive Infiltration With Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE)

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
116
试验地点
1
主要终点
The cumulative butorphanol dose during the 48 hours after surgery via the PCA device.

研究概览

简要总结

Laminoplasty and laminectomy have been used for decades for the treatment of intraspinal space occupying lesions, spinal stenosis, disc herniation, injuries, etc. After these procedures, patients often experience severe postoperative pain at the surgical site. However, current methods of pain control are mostly insufficient. At present, several pain controlling methods are available, to reduce postoperative pain after laminoplasty or laminectomy. Methods for systemic administration include: oral analgesics, intermittent intravenous, intramuscular injections, patient- controlled intravenous analgesia, etc. However, the aforementioned methods may have a lot of side effects, and are usually used after the occurrence of pain and the analgesic effects are sometimes inadequate. Topical administration options use a lower dose of drugs and therefore have less systemic side effects. Pre-emptive injection of local anesthetics can significantly reduce postoperative pain during rest and movement, however, the analgesic effect is maintained for a relatively short period of time. It is necessary to use more cases to explore the other compatibility of drugs with longer duration of action and stronger analgesic effect. Betamethasone as the stereoisomer of dexamethasone is a long-acting corticosteroid, which has long lasting anti-inflammatory properties. Whether betamethasone combined with local anesthetic for laminoplasty or laminectomy has better short-term and long-term effects than the local anesthetic alone has not been reported yet. Therefore, a prospective, randomized, controlled, blinded-endpoint study is needed to compare the postoperative analgesic efficacy of preemptive wound infilteration of ropivacaine alone and betamethasone plus ropivacaine for laminectomy or laminoplasty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for surgery under general anaesthesia for laminectomy or laminoplasty;
  • American Society of Anaesthesiologists (ASA) classification of I or II;
  • Age 18 to 64 years;
  • Participates with an anticipated full recovery within 2 hours postoperatively.

排除标准

  • Patient refusal;
  • Participants who cannot use a patient-controlled analgesia (PCA) device and cannot understand the instructions of a Visual Analogue Score (VAS);
  • Previous history of spinal surgery;
  • Allergy to opioids, betamethasone or ropivacaine;
  • Peri-incisional infection;
  • History of stroke or a major neurological deficit;
  • Trauma, deformity;
  • Psychological problems;
  • Extreme body mass index (BMI) (< 15 or > 35);
  • History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects;
  • Patients using systemic steroids;
  • Pregnant or breastfeeding;
  • Preoperative Glasgow Coma Scale < 15;
  • Participants who have received radiation therapy or chemotherapy preoperatively, or with a high probability to require a postoperative radiation therapy or chemotherapy according to the preoperative imaging.
  • Not able to give written informed consent

研究组 & 干预措施

The Treatment Group

Experimental

The local infiltration solution in the treatment group will consist of betamethasone and ropivacaine.

干预措施: The Treatment group (Drug)

The Control group

Active Comparator

The local infiltration solution in the control group will consist of ropivacaine.

干预措施: The Control group (Drug)

结局指标

主要结局

The cumulative butorphanol dose during the 48 hours after surgery via the PCA device.

时间窗: Within 48 hours after the operation

All participates will receive an electronic intravenous patient-controlled analgesia (PCA) device. Participates will be advised to push the analgesic demand button if they feel pain.

次要结局

  • The Visual Analogue Scale (VAS) during movement (VASm)(At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours, and 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months and 6 months after surgery.)
  • The Postoperative Nausea and Vomiting (PONV)(At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery)
  • The first analgesia demand on the PCA device(Within 48 hours postoperatively)
  • The World Health Organization Quality of Life-BREF (WHOQOL-BREF) scores(At 6 months postoperatively)
  • The Visual Analogue Scale (VAS) at rest (VASr)(At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours, and 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months and 6 months after surgery.)
  • The Oswestry Disability Index (ODI)(Preoperatively and at 4 weeks, 6 weeks and 3 months, 6 months after surgery.)
  • The total times that participants press patient-controlled analgesia button(Within 48 hours after the operation)
  • Patient Satisfaction Score (PSS)(At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 4 weeks, 6 weeks, 3 months and 6 months after surgery)
  • Ramsay Sedation Scale (RSS)(At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery)
  • Patient Scar Assessment and the Observer Scar Assessment Scale (POSAS)(At 6 months postoperatively)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fang Luo

Director of Department of Pain Management

Beijing Tiantan Hospital

研究点 (1)

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