Celiac Plexus Block to Reduce Opioid Consumption Following Hepato-pancreato-biliary Mini-invasive Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Postoperative opioid use
研究概览
简要总结
The goal of this study is to assess the efficacy of intraoperative celiac plexus block (CPB) to reduce opioid consumption following laparoscopic hepato-pancreato-biliary surgery
详细描述
A bilateral CPB is convenient and safe to perform under the direct laparoscopic vision of the surgeons during surgery; however, perspective data are warranted. The investigators hypothesize that a bilateral CPB using 0.5% ropivacaine will improve the quality of recovery following a laparoscopic hepato-pancreato-biliary surgery. The primary endpoint is the Postoperative opioid use. Secondary endpoints include acute postoperative pain, opioid consumption, the incidence of postoperative nausea or vomiting (PONV), the 15-item quality of recovery questionnaire (QoR-15), length of post-anesthesia care unit (PACU) stay, length of post-operative hospital stay, and chronic post-surgical pain at 90 d after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over age 18
- •Undergoing laparoscopic hepato-pancreato-biliary surgery
排除标准
- •Patient refuse
- •Relatively contraindications: severe heart, liver, or kidney dysfunction, coagulation dysfunction, and local anesthetic allergy history
- •Intervention unlikely to be effective: drug abuse history, receiving other types of nerve block treatment
- •Unlikely to complete the follow-up: alcoholism, planned to replace WeChat and phone within three months; the expected life span less than three months
- •Unable to cooperate with the questionnaire and use the patient-controlled analgesia pump
研究组 & 干预措施
Never block
Prior to the end of the laparoscopic surgery and any additional procedures, the bilateral celiac plexus block will be performed by the surgeon after identification of the aorta at the superior border of body of pancreas. A 22-gauge spinal needle will be inserted into the retroperitoneal fat on either side of the aorta under direct vision. Needle aspiration will be performed to exclude entry into vessels before administration of the interventional drug.
The block will contain 20 mL of 0.5% ropivacaine hydrochloride + 1:400000 adrenaline.
Intervention: Drug: 20 mL of 0.5% Ropivacaine
干预措施: Ropivacaine 0.5% (Drug)
Placebo block
Patients in the control arm will undergo the celiac plexus block procedure as well. The block will contain 20 ml of 0.9% normal saline + 1:400000 adrenaline.
Intervention: Drug: 20 mL of 0.9% normal saline
干预措施: Normal Saline (Drug)
结局指标
主要结局
Postoperative opioid use
时间窗: Up to 24 h after surgery
The primary outcome will be morphine equivalent during the first postoperative 24 h
次要结局
- Postoperative opioid use(Up to 72 h after surgery)
- Post-anesthesia care unit (PACU) time(Through study completion, an average of 1 year)
- Post-operative hospital time(Through study completion, an average of 1 year)
- Postoperative vomiting(Up to 72 h after surgery)
- Quality of recovery using the 15-item quality of recovery questionnaire (QoR-15)(Up to 72 h after surgery)
- Numeric rating scale (NRS) for pain(Up to 72 h after surgery)