The Efficacy and Safety of Liposomal Bupivacaine Plus Bupivacaine Local Incisional Infiltration for Postoperative Pain in Patients Undergoing Hemorrhoid 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
- 156
- 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
Hemorrhoids represents the most prevalent condition among anorectal disorders. Due to the unique anatomical characteristics of the perianal region, patients frequently experience severe postoperative pain, which may lead some individuals to delay treatment due to pain-related anxiety. Consequently, effective postoperative pain management is critical for the recovery of hemorrhoid patients. Developing a simplified, efficient, and safe analgesic approach to alleviate postoperative pain has become an urgent issue in perioperative care. Multimodal analgesia regimens recommend the combined use of local anesthetics to synergistically reduce perioperative pain intensity. However, the primary limitation of this analgesic modality lies in the relatively short duration of action following a single injection of local anesthetic.Liposomal bupivacaine is an innovative long-acting, extended-release amide-type local anesthetic that provides analgesic efficacy for up to 72 hours. However, its efficacy and safety for local infiltration analgesia following hemorrhoid surgery have not been fully validated. Against this backdrop, the present study aims to evaluate and compare the clinical outcomes and safety profile of liposomal bupivacaine versus conventional bupivacaine for postoperative pain management via local infiltration in patients undergoing Hemorrhoid 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective Hemorrhoid Surgery 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 group
干预措施: Bupivacaine hydrochloride (Drug)
Liposomal Bupivacaine plus Bupivacaine hydrochloride group
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
- 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.)
- Numeric Rating Scale at rest (NRSr) 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 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.)
- Total hospitalization expenses incurred during the patient's inpatient stay(Perioperation.)
- Postoperative nausea and vomiting，PONV(Postoperatively within 72 hours.)
- Adverse events，AEs(Within 72 hours postoperatively.)
- Area Under the Curve (AUC) of Numeric Rating Scale at move (NRSm) Pain Intensity Scores During 0-72 Hours Postoperatively(Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.)
- Numeric Rating Scale during movement (NRSm) at 1 week, 1 month, and 3 months postoperatively(Postoperative day 7, month 1, and month 3.)
- Total dosage of orally oxycodone and acetaminophen tablets(Within 3 months postoperatively.)
研究者
Fang Luo
Director, Department of Ambulatory Surgery, Principal Investigator, Clinical Professor
Beijing Tiantan Hospital