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临床试验/NCT06430112
NCT06430112招募中3 期

Liposomal Bupivacaine vs Ropivacaine for Ultrasound-guided Transversus Abdominis Plane Blocks in Laparoscopic Lower Abdominal Tumor Resection: A Prospective Randomized Trial

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2023年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
74
试验地点
1
主要终点
Postoperative opioid use

研究概览

简要总结

Few studies have compared the efficacy of ultrasound (US)-guided TAP blocks with Liposomal bupivacaine(LB) versus ropivacaine in reducing postoperative opioid usage in patients undergoing laparoscopic lower abdominal tumor Resection. Therefore, we are conducting this prospective, randomized controlled trial to compare the postoperative analgesic effects of LB and ropivacaine for TAP blocks among patients undergoing laparoscopic colorectal procedures.

详细描述

This study aimed to investigate the impact of liposomal bupivacaine (LB) on postoperative opioid usage for ultrasound(US)-guided transversus abdominis plane (TAP) blocks in laparoscopic colorectal resections. We divided 76 patients into two groups. An injection of bilateral TAP blocks was administered to LB group using 133mg liposomal bupivacaine in each block (266mg total), and to R group using 20 ml 0.25% ropivacaine in each block (40 ml total). Opioid consumption and pain scores at 6h, 24h, 48h and 72h were recorded postoperatively, as well as the total intraoperative remifentanil dose, the hospital stay lengths after surgery, and adverse events including dizziness, nausea, and vomiting.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing laparoscopic resection of lower abdominal tumors
  • ASA grade II-III
  • Age: 18-70 years.

排除标准

  • (1) The patient does not agree to participate in the clinical study
  • (2) The patient has a clear history of opioid tolerance or allergy
  • (3) The patient has a history of local anesthetic allergy
  • (4) Previous history of dementia, mental illness or other central nervous system diseases
  • (5) Have a history of chronic pain or are taking opioids and other analgesics
  • (6) Patients are generally in poor condition with a history of serious diseases of cardiovascular system, respiratory system, digestive system, urinary system or central nervous system, and may not survive for more than 3 months
  • (7) The patient had any of the following conditions in the 12 months before surgery: myocardial infarction, severe/unstable angina pectoris, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident, pulmonary embolism
  • (8) Pregnant women
  • (9) Unable to cooperate with follow-up or poor compliance
  • (10) Patients with acute myocardial infarction, cardiac arrest or shock during surgery or hospitalization
  • (11) ASA score above grade III.

研究组 & 干预措施

Liposomal Bupivacaine group

Experimental

Liposomal Bupivacaine was used in the group

干预措施: Liposomal Bupivacaine (Drug)

Ropivacaine group

Active Comparator

Ropivacaine was used in this group

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Postoperative opioid use

时间窗: 3 days postoperatively

The amount of drug used in the postoperative analgesia pump

次要结局

  • Postoperative adverse reactions(3 days postoperatively)
  • Postoperative pain score(3 days postoperatively)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ping Yu

Doctor

Sun Yat-sen University

研究点 (1)

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