Comparing pain relief methods for minimally invasive esophagectomy

Comparison of Efficacy and Safety of Different Analgesic Modes in Minimally Invasive Esophagectomy for Esophageal Cancer

This study is testing different ways to manage pain for people with esophageal cancer undergoing minimally invasive surgery to see which method works best and has the fewest side effects.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05504265 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of various analgesic methods during and after minimally invasive esophagectomy for patients with esophageal cancer. It will compare preemptive and postoperative administration of flurbiprofen axetil and the use of a patient-controlled analgesia pump. The goal is to determine which method provides the best pain management while minimizing side effects. Participants will be monitored for pain levels and any adverse reactions throughout the perioperative period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who are scheduled for laparoscopic, thoracoscopic, or robotic-assisted minimally invasive esophagectomy.

Not a fit: Patients with recent history of certain medical conditions, severe lung diseases, or those who are opioid-tolerant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing esophagectomy, enhancing recovery and quality of life.

How similar studies have performed: Previous studies have shown promising results in pain management using similar analgesic approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* 18-75 years;
* Patients underwent laparoscopic and thoracoscopic or robotic-assisted minimally invasive esophagectomy ;
* Informed consent.

Exclusion Criteria:

* Has a history of cholecystitis or urolithiasis within 3 months;
* Has a history of atherothrombosis (peripheral arterial disease), stroke, myocardial infarction;
* With lung diseases, such as pneumonia, atelectasis, emphysema, pulmonary bullae, etc;
* Preoperative cardiac function grade ≥ III or coronary artery stenosis;
* Preoperative indwelling of a thoracic drainage tube;
* Long-term heavy drinker(heavy drinking was defined as follows: for men, consuming more than 4 drinks on any day or more than 14 drinks per week; For women, consuming more than 3 drinks on any day or more than 7 drinks per week);
* Opioid-tolerant patients(defined as those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid);
* With painful skin complications, such as rashes and blisters;
* Conversion to open surgery;
* The postoperative ventilation function was limited, or the duration of endotracheal intubation was more than 24h.

Where this trial is running

Beijing

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: zhu zhixiang

Conditions: Esophageal Cancer, Perioperative Analgesia, NSAIDs, Opioid, Patient-controlled Analgesia