Application of Celiac Plexus Block in Postoperative Analgesia of Whipple Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Opioid consumption
研究概览
简要总结
This subject intends to explore the value of intraoperative celiac plexus block in postoperative acute pain management and its promoting effect on patients' rapid recovery during Whipple surgery through a randomized controlled trial.
详细描述
This study is a single center, randomized, single-blind controlled study. After calculating the sample size, 66 subjects would be randomly assigned to nerve block group (NB group: local anesthetic injection at the target position) and blank control group (GC group: no celiac plexus block) according to the ratio of 1:1, in order to evaluate the effectiveness and safety of celiac plexus block (CPB) as a part of multimodal analgesia for postoperative pain management.
Anesthesia protocol: the standard anesthesia protocol for open Whipple surgery in our hospital was adopted.
Postoperative analgesia plan: before abdominal closure at the end of operation, The surgeon was instructed to perform a single celiac plexus block (CPB) under direct vision. Ropivacaine was injected into the target nerve in NB group, but no injection in GC group. After the operation, the anesthesiologist used ropivacaine to perform ultrasound-guided abdominal wall nerve block. When leaving the operating room, connect intravenous analgesia pump. Patients with subjective pain score of 3 or above can press. If the analgesia is insufficient, intravenous injection of dezocine can be added temporarily. The intravenous analgesia pump shall be withdrawn after 72 hours of use. If the analgesia pump is used up and is still needed, the anesthesiologist can evaluate and add medicine.
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
- Double (Participant, 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
- •age ≥ 18years;
- •received open Whipple surgery.
排除标准
- •patients unable to cooperate with evaluations;
- •patients with history of drug abuse, local anesthetic allergy, anatomical variation of the celiac ganglia indicated by abdominal CT, abdominal aortic diseases;
- •non-standard surgical procedures, planned postoperative ICU admission;
- •American Society of Anesthesiologists (ASA) classification of 4 or
- •Withdrawal criteria:
- •Patients who underwent unplanned surgeries, required reintubation or a second surgery, received ICU care within three days post-surgery, died within two weeks post-surgery, or experienced any unexpected events were withdrawn from the study.
研究组 & 干预措施
NB group
Celiac plexus block (CPB) was added to the postoperative analgesia plan.
CPB: the target nerve is located in the retroperitoneal space, embedded in the fat in front of the aorta, and distributed in a network along the anterolateral wall of the aorta, just at the beginning of the celiac trunk. During direct vision (anterior) block, first expose the upper edge of the pancreas, palpate the abdominal aorta and abdominal trunk, and palpate the pulsation of the common hepatic artery and splenic artery at the level of the abdominal trunk. Use a 25g 6cm puncture needle with an extension tube and a syringe pumped back by an assistant to form a negative pressure, then the needle is inserted into the fat on both sides of the abdominal aorta. If there is no blood or fluid outflow, slowly inject 10ml of 0.5% ropivacaine each side. After pulling out the needle, observe whether there is damage and bleeding. If necessary, use low-energy electrocoagulation to stop bleeding.
干预措施: Celiac plexus block (Procedure)
NB group
Celiac plexus block (CPB) was added to the postoperative analgesia plan.
CPB: the target nerve is located in the retroperitoneal space, embedded in the fat in front of the aorta, and distributed in a network along the anterolateral wall of the aorta, just at the beginning of the celiac trunk. During direct vision (anterior) block, first expose the upper edge of the pancreas, palpate the abdominal aorta and abdominal trunk, and palpate the pulsation of the common hepatic artery and splenic artery at the level of the abdominal trunk. Use a 25g 6cm puncture needle with an extension tube and a syringe pumped back by an assistant to form a negative pressure, then the needle is inserted into the fat on both sides of the abdominal aorta. If there is no blood or fluid outflow, slowly inject 10ml of 0.5% ropivacaine each side. After pulling out the needle, observe whether there is damage and bleeding. If necessary, use low-energy electrocoagulation to stop bleeding.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Opioid consumption
时间窗: 72 hours after surgery
Morphine equivalent
次要结局
- Press of the analgesic pump(Every 24 hours post-surgery for 72 hours)
- White blood cell count(At the end of surgery and 24 hours post-surgery)
- C-reactive protein(At the end of surgery and 24 hours post-surgery)
- Interleukin-6(At the end of surgery and 24 hours post-surgery)
- Systemic vascular resistance index changes during celiac plexus block(Before and 5、10、20 minutes after CPB)
- Time to first flatus(72 hours after surgery)
- Erythrocyte sedimentation rate(At the end of surgery and 24 hours post-surgery)
- Length of postoperative hospitalization(After surgery to before discharge, up to 2 months)
- Procalcitonin(At the end of surgery and 24 hours post-surgery)
- Pain scores(6, 12, 24, 48, 72 hours after surgery)
- Postoperative mean arterial pressure(Every 12 hours post-surgery for 72 hours)
- Cardiac index changes during celiac plexus block(Before and 5、10、20 minutes after CPB)
- Postoperative heart rate(Every 12 hours post-surgery for 72 hours)