The Efficacy and Safety of Liposomal Bupivacaine Plus Bupivacaine Transversus Abdominis Plane Block for Postoperative Pain in Patients Undergoing Laparoscopic Surgery:A Multi-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
研究概览
简要总结
Laparoscopic surgery has become the preferred approach for abdominal surgical interventions due to its advantages of minimal invasiveness, rapid recovery, and reduced complication rates. Despite its minimally invasive nature, postoperative pain persists and adversely affects patient recovery. In the absence of effective pain management, acute pain may progress to chronic pain. Although opioids provide reliable analgesic effects, their associated adverse reactions limit their application following minimally invasive procedures. Regional analgesia serves as the cornerstone of multimodal analgesia, and ultrasound-guided nerve block techniques have become increasingly refined. Ultrasound-guided transversus abdominis plane block(TAPB) generally fulfills intraoperative and postoperative analgesic requirements for laparoscopic surgeries by inhibiting the transmission of nociceptive stimuli in the targeted region, thereby aiding in the prevention of central sensitization. Conventional TAPB utilize local anesthetics, which demonstrate excellent efficacy in alleviating incisional pain. However, the short duration of analgesia provided by conventional local anesthetics significantly compromises their clinical utility.Liposomal bupivacaine(LB) is a novel, long-acting, sustained-release amide-type local anesthetic, providing localized analgesic effects for up to 72 hours.However, its efficacy and safety in laparoscopic surgery not yet been fully validated. Based on this premise, the present study aims to evaluate and compare the clinical outcomes of Ultrasound-guided TAPB utilizing liposomal bupivacaine plus bupivacaine for postoperative pain management in patients undergoing laparoscopic surgery.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Patients scheduled for elective laparoscopic cholecystectomy, hernia repair, and appendectomy under general anesthesia;
- •Ages 18 to 64 years old；
- •American Society of Anesthesiologists (ASA) physical status of I-III；
- •Glasgow Coma Scale (GCS) score of 15；
- •Patients must be able to understand the nature and potential personal consequences of the clinical trial, signing of the informed consent form.
排除标准
- •History of chronic pain syndrome of any cause.
- •Patients with heart conduction block (sinus block or atrioventricular block).
- •Patients with unstable coronary artery disease.
- •Patients with gastric ulcer or gastric bleeding.
- •Patients with diabetes and are being treated with insulin.
- •Subjects with coagulation dysfunction (prothrombin time or activated partial thromboplastin time is higher than the normal threshold) or patients who are taking oral anticoagulants for other medical reasons and have not stopped it before surgery, such as warfarin or new anticoagulants rivaroxaban or dabigatran.
- •Patients with abnormal liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2× the upper limit of normal (ULN) or total bilirubin (TBIL) ≥ 1.5×ULN.
- •Patients with renal impairment (serum creatinine > 176 µmol/L) or receiving dialysis treatment within 28 days before surgery.
- •Patients with a history of diagnosed mental illness or currently taking psychotropic medication.
- •Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 h before surgery.
- •Pregnancy or breastfeeding.
- •Extreme body mass index (BMI) (< 15 or > 35).
- •Participation in another interventional trial that interferes with the intervention or outcome of this trial.
- •Patients with a history of allergy to local anaesthetics or one of the study drugs.
研究组 & 干预措施
Bupivacaine hydrochloride
干预措施: Bupivacaine hydrochloride (Drug)
Liposomal bupivacaine plus bupivacaine
干预措施: Liposomal bupivacaine plus bupivacaine (Drug)
结局指标
主要结局
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
时间窗: The postoperative period 48 hours.
次要结局
- Total hospitalization expenses incurred during the patient's inpatient stay(Perioperation.)
- Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively(Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.)
- Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively(Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.)
- Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively(Postoperative day 7, month 1, and month 3.)
- Postoperative nausea and vomiting，PONV(Postoperatively within 72 hours.)
- Cumulative sufentanil dose for four separate periods (0-4, 4-8, 8-24, and 24-48 h), a total press count including both valid and invalid presses(Postoperative Hours 4, 8, 24, and 48.)
- Numeric Rating Scale during movement (NRSm) at 1 week, 1 month, and 3 months postoperatively(Postoperative day 7, month 1, and month 3.)
- Time to request of first analgesia(Within 48 hours postoperatively.)
- Duration days of Oral Oxycodone and Acetaminophen Tablets Administration(Within 3 months postoperatively.)
- Total dosage of orally oxycodone and acetaminophen tablets(Within 3 months postoperatively.)
- Intraoperative Anesthetic Dosage(During the surgical anesthesia phase.)
- Patient Satisfaction Scale，PSS(Postoperative hours 2, 24, 48, and 72; week 1; month 1; and month 3.)
- Ramsay Sedation Scale，RSS(Postoperative at 2 hours, 24 hours, 48 hours, and 72 hours.)
- Quality of Recovery-40，QoR-40(Postoperative hours 24, 48, and 72.)
- The duration of stay in the post-anesthesia care unit（PACU）(The time from the end of surgery until transferred back to the ward.Typically, patients are transferred back to the ward after approximately 30 to 60 minute.)
- Length of Stay (LOS)(Perioperation.)
- Adverse events，AEs(Within 72 hours postoperatively.)
研究者
Fang Luo
Director, Department of Ambulatory Surgery, Principal Investigator, Clinical Professor
Beijing Tiantan Hospital