Effects of Pre-emptive Scalp Infiltration With Low-dose Ketorolac and Ropivacaine for Postoperative Pain Relief After Elective Supratentorial Craniotomy (PAINLESS): a Randomized Controlled Pilot Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 主要终点
- cumulative doses of patient-controlled analgesia (PCA) sufentanil consumption
研究概览
简要总结
The PAINLESS study is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled clinical pilot 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.
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 scalpinfiltration will be performed using 30ml of 60 mgropivacaine and 0.1mg epinephrine.
干预措施: Ropivacaine (Drug)
The control group
In the control group, preoperative peri-incisional scalpinfiltration will be performed using 30ml of 60 mgropivacaine 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) sufentanil consumption
时间窗: 0 to 48 hours postoperatively
cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively The primary outcome measure will be cumulative doses of PCA butorphanol consumption from 0 to 48 h postoperatively
次要结局
- The time to first request for PCA sufentanil(0 to 48 hours postoperatively)
- frequency of pressing PCA pump(Within 48hours postoperatively)
- postoperative nausea and vomiting(PONV)(within 48 hours postoperatively)
- The incidence of haematoma, wound infection or gastric ulcers(during hospitalization, within 2 weeks postoperatively)
- Pain control satisfaction score (PCSS) postoperatively(at 24 hours and 48 hours post-operation)
- 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)
- 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)
- Length of hospital stay(Length of hospital stay, an arverage of 2 weeks)
- numeral rating scale (NRS) Score(at 2 hours, 4 hours, 8 hours, 24 hours, 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 postope)
- Ramsay sedation score (RSS)(at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours postoperatively)
- The presence of respiratory depression(within 48 hours postoperatively)
研究者
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital