Effects of Pre-emptive Scalp Infiltration With Ropivacaine and Methylprednisolone- Ropivacaine on Pain After Craniotomy in Adults
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Cumulative butorphanol consumption within 48 hours postoperatively
研究概览
简要总结
Pain is common for the first 2 days after major craniotomy. A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. Inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications. Adequate pain control is essential for patients' prognosis and their postoperative life quality. Pain after craniotomy derives from the scalp and pericranial muscles. Local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. Pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp infiltration does not seem to meet the requirements of craniotomy. Steroid such as methylprednisolone as an adjuvant to local anesthetics intra-articular injected locally reduced pain intensity after total knee arthroplasty or lumbar discectomy. However, there has not been reported about local application of methylprednisolone on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (methylprednisolone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.
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
- Double (Participant, 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
- 否
入选标准
- •Patients scheduled for elective craniotomy for resection of tumour under general anaesthesia;
- •American Society of Anesthesiologists (ASA) physical status of I , II or III;
- •Participates with an anticipated fully recovery within 2 hours postoperatively.
排除标准
- •History of craniotomy;
- •Expected delayed extubation or no plan to extubate;
- •Participants who cannot use a patient-controlled analgesia (PCA) device;
- •• Participants who cannot understand the instructions of a numeral rating scale (NRS) 35 before surgery;
- •Extreme body mass index (BMI) (< 15 or > 35);
- •Allergy to opioids, methylprednisolone or ropivacaine;
- •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;
- •History of psychiatric disorders, uncontrolled epilepsy or chronic headache;
- •Pregnant or at breastfeeding;
- •Symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes;
- •Preoperative Glasgow Coma Scale< 15;
- •Suspicion of intracranial hypertension;
- •Peri-incisional infection;
- •Participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.
研究组 & 干预措施
The MP/RP group
Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, 40mg methylprednisolone, plus 10ml saline;
干预措施: The MP/RP group (Drug)
The RP group
Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, plus 10ml saline;
干预措施: The RP group (Drug)
结局指标
主要结局
Cumulative butorphanol consumption within 48 hours postoperatively
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 first time to press the patient-controlled analgesia button(Within 48 hours after the operation)
- The total times that participants press patient-controlled analgesia button(Within 48 hours postoperatively)
- Numerical rating scale (NRS)(At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months after surgery)
- Postoperative nausea and vomiting(At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery)
- Ramsay Sedation Scale (RSS)(At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery)
- Respiratory depression(Within 48 hours after the operation)
- The times of emergency reducing blood pressure after the operation(Within 48 hours after the operation)
- Patient satisfactory scale (PSS)(At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months after surgery)
- The total consumption of opioids during the operation(During procedure)
- The length of stay(Approximately 2 weeks after the surgery)
- The World Health Organization Quality of Life (WHOQOL)-BREF(At 1 month, 3 months and 6 months after surgery)
- The number of participants who have no butorphanol consumption(Within 48 hours after the operation)
- Wound Healing Score(At 1 month after surgery)
研究者
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital