The Efficacy and Safety of Liposomal Bupivacaine Plus Bupivacaine Local Incisional Infiltration 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
- 190
- 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
Compared with traditional laparotomy, laparoscopic surgery offers advantages including minimal invasiveness, accelerated patient recovery, and reduced hospital stay. Although postoperative incision pain is generally less severe than that following laparotomy, it remains a notable clinical issue that impedes patient recovery. The majority of patients report incisional discomfort, with approximately 30% to 50% requiring oral analgesics to alleviate pain symptoms. Within the first two days after laparoscopic procedures, most patients experience varying degrees of incisional pain, with peak intensity typically occurring within hours after surgery and gradually subsiding over two to three days. Studies indicate that local infiltration anesthesia at the surgical site significantly ameliorates postoperative incision pain, enhances analgesic efficacy, and shortens recovery time in patients undergoing laparoscopic surgery.Liposomal bupivacaine(LB) is a novel, long-acting, sustained-release amide-type local anesthetic, providing localized analgesic effects for up to 72 hours. Some researchers have reported the analgesic effects of LB VS traditional local anesthetics infiltration, but the current research results are highly heterogeneous. More prospective studies are needed to evaluate whether LB infiltration is superior to the traditional local anesthetics for the management of postoperative pain. The investigators designed this study to compare the analgesic effect of using LB plus bupivacaine for local infiltration with bupivacaine along for patients after 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
- Postoperative nausea and vomiting，PONV(Postoperatively within 72 hours.)
- 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.)
- 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.)
- 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.)
- Duration days of Oral Oxycodone and Acetaminophen Tablets Administration(Within 3 months postoperatively.)
- 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 length 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.)
- Total hospitalization expenses incurred during the patient's inpatient stay(Perioperation.)
- Total dosage of orally oxycodone and acetaminophen tablets(Within 3 months postoperatively.)
- Adverse events，AEs(Within 72 hours postoperatively.)
研究者
Fang Luo
Director, Department of Ambulatory Surgery, Principal Investigator, Clinical Professor
Beijing Tiantan Hospital