Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Postoperative Pain Relief After Elective Supratentorial Craniotomy (PAINLESS)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 主要终点
- cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively
研究概览
简要总结
The PAINLESS study is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled clinical study to compare the efficacy and safety of pre-emptive scalp infiltration with ropivacaine plus ketorolac and ropivacaine alone for postoperative pain relief in adults undergoing elective supratentorial craniotomies.
详细描述
The proposed study will be a single-center, prospective, randomized, open-label, blinded-endpoint clinical trial designed to test the hypothesis that the addition of ketorolac to pre-emptive scalp infiltration analgesia can significantly improve analgesia after craniotomies. One hundred participants will be randomized to the ketorolac group or the control group. Patients in the ketorolac group will receive pre-emptive scalp infiltration with opivacaine,ketorolac and epinephrine while patients in the control group will receive pre-emptive scalp infiltration with ropivacaine and epinephrine.The primary outcome measure will be cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective supratentorial tumour resection;
- •Planned general anaesthesia;
- •American Society of Anesthesiologists (ASA) physical status I - II;
- •Age ranging from 18 to 65 years old;
- •Participates required to fix their head in a head clamp intraoperatively;
- •Participates with an anticipated awake within 2 hours after surgery.
排除标准
- •Allergy/intolerance to study drugs including anesthetic drugs, ketorolac and epinephrine;
- •Expected delayed extubation or no plan to extubate;
- •History of neurosurgeries;
- •Long-term use of analgesics and sedatives (more than 2 weeks)
- •Receiving any painkiller within 24 h before the operation;
- •Extreme body mass index (BMI) (less than 15 or more than 35);
- •Patients with impaired cardiopulmonary;
- •Patients with impaired renal function;
- •Patients with impaired hepatic function;
- •History of chronic headache;
- •Patients with cognitive deficit;
- •Patients with intellectual disability;
- •Patients with uncontrolled epilepsy;
- •Patients with psychiatric disorders;
- •Difficulties in using PCA device
- •Difficulties in understanding the use of numeral rating scale (NRS) ;
- •Patients with suspected intracranial hypertension;
- •Pregnant or at breastfeeding;
- •Infection at the incisional site；
- •History of radiation therapy and chemotherapy preoperatively
- •With great likelihood of postoperative radiation therapy and chemotherapy based on preoperative imaging.
研究组 & 干预措施
The ketorolac group
Patients assigned to the ketorolac group will receive pre-emptive scalp infiltration with 30ml of local infiltration solution containing 60 mg ropivacaine, 6 mg ketorolac and 0.1mg epinephrine.
干预措施: Ketorolac (Drug)
The ketorolac group
Patients assigned to the ketorolac group will receive pre-emptive scalp infiltration with 30ml of local infiltration solution containing 60 mg ropivacaine, 6 mg ketorolac and 0.1mg epinephrine.
干预措施: Ropivacaine (Drug)
The ketorolac group
Patients assigned to the ketorolac group will receive pre-emptive scalp infiltration with 30ml of local infiltration solution containing 60 mg ropivacaine, 6 mg ketorolac and 0.1mg epinephrine.
干预措施: Epinephrine (Drug)
The control group
In the control group, preoperative peri-incisional scalp infiltration will be performed using 30ml of 60 mg ropivacaine and 0.1mg epinephrine.
干预措施: Ropivacaine (Drug)
The control group
In the control group, preoperative peri-incisional scalp infiltration will be performed using 30ml of 60 mg ropivacaine and 0.1mg epinephrine.
干预措施: Epinephrine (Drug)
结局指标
主要结局
cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively
时间窗: 0 to 48 hours postoperatively
The primary outcome measure will be cumulative doses of PCA butorphanol consumption from 0 to 48 h postoperatively
次要结局
- pulse oxygen saturation(SpO2)(1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively)
- frequency of pressing patient-controlled analgesia pump(Within 48hours postoperatively)
- numeral rating scale (NRS) Score(at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months postoperatively)
- Pain control satisfaction score (PCSS) postoperatively(at 24 hours, 48 hours, 72 hours, 1 week, 1 month, 3 months and 6 months)
- Ramsay sedation score (RSS)(at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours and 72 hours postoperatively)
- mean arterial blood pressure(MAP)(1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively)
- heart rate(HR)(1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively)
- respiratory rate(RR)(1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively)
- Length of hospital stay(Length of hospital stay, an arverage of 2 weeks)
- Wound healing score(at 3 weeks and 6 weeks after surgery)
- postoperative nausea and vomiting(PONV)(within 48 hours postoperatively)
- The presence of respiratory depression(within 48 hours postoperatively)
- The incidence of haematoma, wound infection or gastric ulcers(during hospitalization, within 2 weeks postoperatively)
- The time to first request for patient-controlled analgesia butorphanol(Within 48hours postoperatively)
研究者
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital