Preemptive Co-infiltration of Dexamethasone Palmitate Emulsion With Ropivacaine for Postoperative Pain in Patients Undergoing Major Spinal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- The cumulative consumption of sufentanil within 24 hours after spinal surgery via the PCA pump.
研究概览
简要总结
Patients undergoing major spinal surgery usually experience moderate-to-severe postoperative pain. Inadequate pain control may lead to severe complications. Dexamethasone as an adjunctive infiltration to local anesthesia (LA) presented a superior analgesic benefit compared with LA alone in various types of surgeries. However, a recent meta-analysis showed that the additional analgesic effect of dexamethasone in incision/wound infiltration was only statistically significant, but not clinically significant, and the overall benefits were marginal. Compared with dexamethasone, dexamethasone palmitate emulsion (DXP) is a targeted lipo-steroid with stronger anti-inflammatory effect, longer-acting duration and fewer adverse effects. To date, no studies have evaluated the additive analgesia effects of DXP on incision infiltration in major spinal surgery. The purpose of this trial is to determine whether preemptive co-infiltration of DXP emulsion and ropivacaine in surgical incision will further reduce postoperative opioid requirements and pain score after spinal surgery than that of ropivacaine alone.
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
- •Age 18-64 years;
- •Patients scheduled for elective laminoplasty or laminectomy with no more than 3 levels under general anesthesia
- •American Society of Anesthesiologists (ASA) physical status of I-III;
- •Anticipated full recovery and cooperation within 2 hours postoperatively.
排除标准
- •History of spinal surgery;
- •Inability to use a patient-controlled analgesia (PCA) pump or comprehend the pain visual analog scale (VAS);
- •Body mass index (BMI)<15kg/m2 or >35kg/m2;
- •Peri-incisional infection;
- •History of diabetes mellitus and other metabolic diseases;
- •History of severe cardiopulmonary, hepatic or renal dysfunction;
- •Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 times normal value);
- •History of allergies to any of the study drugs;
- •History of alcohol or drugs abuse (more than 2 weeks), or use of any analgesic within 24h before surgery;
- •Use of systemic steroids within 1 week before surgery;
- •History of psychiatric disorders, chronic neck or back pain;
- •History of radiation therapy and chemotherapy or with a high probability of such treatment postoperatively;
- •Pregnant or breastfeeding;
- •Refusal to sign informed consent.
研究组 & 干预措施
The dexamethasone palmitate emulsion(DXP) plus ropivacaine group
The local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of dexamethasone palmitate emulsion(DXP) and ropivacaine.
干预措施: Dexamethasone palmitate emulsion(DXP) plus ropivacaine (Drug)
The ropivacaine alone group
The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone.
干预措施: Ropivacaine alone (Drug)
结局指标
主要结局
The cumulative consumption of sufentanil within 24 hours after spinal surgery via the PCA pump.
时间窗: Within 24 hours after spinal surgery
All participates will receive an electronic intravenous patient-controlled analgesia (PCA) pump. Participates will be advised to push the analgesic demand button if they feel pain.
次要结局
- The time of first PCA demand(Within 48 hours after spinal surgery)
- Patient Satisfaction Score (PSS) with pain relief(At 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks 1 month and 3 months postoperatively)
- Duration of hospitalization after surgery(Approximately 1-2 weeks after surgery)
- Postoperative VAS score at rest(VASr)(At 2 hours, 4 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks, 1 month and 3 months postoperatively)
- Total consumption of Tylenol as supplementary analgesia(Four separate postoperative periods ( 0- postoperative 48 hours, postoperative 48 hours-postoperative 2 weeks, postoperative 2 weeks-postoperative 1 month, and postoperative 1 month-postoperative 3 months))
- Rate of steroid-related side effects and complications(Through the whole follow-up, an average of 3 months)
- Readmission rate within 3 months after spine surgery;(Through the whole follow-up, within 3 months after spine surgery)
- The cumulative consumption of sufentanil via PCA pump between 24 hours and 48 hours postoperatively.(Between 24 hours and 48 hours after spinal surgery)
- Number of patients without PCA press button(Within 48 hours after spinal surgery)
- The total number of PCA presses including both valid and invalid presses(Within 48 hours after spinal surgery)
- Ramsay Sedation Scale (RSS)(At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively)
- Postoperative visual analogue scale (VAS) score during movement(VASm)(At 2 hours, 4 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks, 1 month and 3 months postoperatively)
- Postoperative nausea and vomiting (PONV) score(At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively)
- Total consumption of loxoprofen(From postoperative 48 hours to approximately 1-2 weeks after surgery)
- Patient Scar Assessment and the Observer Scar Assessment Scale (POSAS)(At 2 weeks, 1 month and 3 months postoperatively)
- Length of Postoperative Anesthesia Care Unit (PACU) stay(Approximately 30 minutes to 2 hours after surgery)
- Total consumption of remifentanil during surgery(During surgery)
研究者
Fang Luo
Director of Department of Day Surgery and Pain Management
Beijing Tiantan Hospital