Pilot Comparative Study on the Efficacy of Multimodal Management With Peritoneal Lavage Using Saline Solution Versus Saline Solution With Ondansetron in Laparoscopic Cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total Pain Burden as Measured by the Area Under the Curve (AUC) of Visual Analog Scale (VAS) Scores Over the First 24 Postoperative Hours
研究概览
简要总结
Brief Summary Background: Laparoscopic cholecystectomy is a common procedure where postoperative pain and nausea/vomiting (PONV) remain significant issues, impairing recovery. Standardized multimodal analgesia (e.g., PROSPECT guidelines) is effective for pain, but PONV incidence stays high. Preliminary evidence suggests that adding ondansetron to the standard intraperitoneal saline lavage could provide additional analgesic and antiemetic benefits by blocking peripheral 5-HT3 receptors at the trauma site.
Objective: This pilot study aims to evaluate if intraperitoneal lavage with saline + 8mg ondansetron reduces the total burden of postoperative pain over the first 24 hours (Area Under the Curve of the Visual Analog Scale, AUC-VAS/24h) compared to saline lavage alone, within a standardized multimodal protocol.
Methods: This is a phase IV, pilot, randomized, controlled, triple-blind clinical trial. 40 adult patients (ASA I-II) undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis (Nassar Grade I-II difficulty) will be randomly assigned (1:1) to:
Control Group: 500 ml of 0.9% saline intraperitoneal lavage.
Intervention Group: 500 ml of 0.9% saline + 8 mg ondansetron intraperitoneal lavage.
The lavage is performed for 5 minutes at the end of surgery, followed by complete aspiration. All patients receive a strict multimodal perioperative protocol, including pre-incisional port site infiltration with bupivacaine 0.75%, standardized anesthesia, and postoperative analgesics. The use of intravenous ondansetron is prohibited to avoid confounding.
Primary Outcome: Total postoperative pain burden (AUC-VAS/24h). Secondary Outcomes (Exploratory): PONV incidence; time to first rescue analgesia; rescue analgesic consumption (buprenorphine); postoperative sleep quality (Richards-Campbell Sleep Questionnaire); safety and adverse events.
详细描述
- Study Rationale and Background Postoperative pain and PONV are prevalent after laparoscopic cholecystectomy, leading to patient discomfort, prolonged hospitalization, and increased resource use. The PROSPECT guidelines recommend a multimodal approach, including intraperitoneal saline lavage, to mitigate pain by diluting irritants and reducing acidosis. However, even with this approach, PONV rates remain high (30-50%).
Ondansetron, a 5-HT3 antagonist, is a established antiemetic. Emerging evidence indicates a peripheral analgesic mechanism via blocking 5-HT3 receptors on nociceptive neurons, inhibiting neuropeptide release, and potential local anesthetic effects. Administering it intraperitoneally targets the site of surgical trauma. A previous study (Abdelaziz et al., 2021) using 4mg showed promise, but it had a small sample size and was not integrated into a strict, modern multimodal protocol. This pilot study addresses this gap by testing an 8mg dose within a rigorous, standardized PROSPECT-aligned protocol, using the AUC-VAS/24h to comprehensively capture the pain burden. 2. Overall Study Design and Methodology This is a single-center, prospective, phase IV, randomized, controlled, triple-blind, parallel-group pilot study, designed and reported according to CONSORT guidelines for pilot trials.
Blinding (Triple):
Patients are unaware of their assignment.
Care Providers & Outcome Assessors: Surgeons, anesthesiologists, nurses, and research interns collecting data are all blinded.
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)
盲法说明
This is a triple-blind study. Beyond the participant, the following key parties are masked: the surgeons performing the procedure, the anesthesiologists managing perioperative care, and the post-operative outcome assessors (e.g., research interns collecting pain scores and other clinical data). A designated "blinding coordination nurse," who is not involved in any clinical or assessment roles, prepares the identical-looking solutions according to the randomization sequence. The data analyst will also remain masked to group allocation (coded as A/B) until the completion of the primary statistical analysis.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Saline Lavage Only
Participants in this arm will receive intraoperative peritoneal lavage with 500 mL of 0.9% saline solution for 5 minutes at the end of laparoscopic cholecystectomy. The solution will be fully aspirated before abdominal closure. The solution will remain in the peritoneal cavity for 5 minutes and then be completely aspirated before closure. All participants will also receive standard multimodal analgesia including paracetamol, diclofenac, and local wound infiltration with bupivacaine.
干预措施: Saline Intraperitoneal Lavage (Drug)
Saline Lavage With Ondansetron
Participants in this arm will undergo peritoneal lavage with 500 mL of 0.9% saline solution combined with 8 mg of ondansetron, administered intraperitoneally at the end of elective laparoscopic cholecystectomy. The solution will remain in the peritoneal cavity for 5 minutes and then be completely aspirated before closure. All participants will also receive standard multimodal analgesia including paracetamol, diclofenac, and local wound infiltration with bupivacaine.
干预措施: Ondansetron Intraperitoneal Lavage (Drug)
结局指标
主要结局
Total Pain Burden as Measured by the Area Under the Curve (AUC) of Visual Analog Scale (VAS) Scores Over the First 24 Postoperative Hours
时间窗: 0, 2, 6, 12, and 24 hours postoperatively
The primary outcome is the total burden of postoperative pain, quantified as the Area Under the Curve (AUC) of serial Visual Analog Scale (VAS) scores measured at 0, 2, 6, 12, and 24 hours after surgery. The AUC is calculated using the trapezoidal rule, which integrates both the intensity and duration of pain into a single composite measure (units: mm\*hour). This provides a more comprehensive assessment of the patient's pain experience over the critical first postoperative day than isolated time-point measurements. A lower AUC indicates superior pain control.
次要结局
- Incidence of Postoperative Nausea and Vomiting (PONV)(0, 2, 6, 12, and 24 hours postoperatively)
- Use of Rescue Analgesia Within 24 Hours Postoperatively(0 to 24 hours postoperatively)
- Postoperative Sleep Quality Assessed by the Richards-Campbell Sleep Questionnaire(Night of surgery to morning after surgery)
- Incidence of Adverse Events Possibly Related to Intraperitoneal Ondansetron(0 to 24 hours postoperatively)
研究者
Francisco Aguilar Espinosa
General Surgery department: Dr. Francisco Aguilar Espinosa, Clinical Research
Instituto Mexicano del Seguro Social