Perioperative Analgesia Modes in Minimally Invasive Esophagectomy

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Not yet enrolling; Phase 3; Phase 2

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

Treatments: Drug: Preemptive flurbiprofen axetil; Drug: Postoperative flurbiprofen axetil; Device: Patient-controlled analgesia pump

Study type: Interventional

Funder types: Other

Identifiers

NCT05504265

22/166-3367

Details and patient eligibility

About

This study was designed to compare analgesic efficacy and safety of different perioperative analgesic modes in minimally invasive esophagectomy for esophageal cancer.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 3 patient groups

Postoperative NSAIDs

Other group

Treatment:

Drug: Postoperative flurbiprofen axetil

Preemptive analgesia followed by Postoperative NSAIDs

Experimental group

Treatment:

Drug: Postoperative flurbiprofen axetil

Drug: Preemptive flurbiprofen axetil

Postoperative patient-controlled analgesia pump

Experimental group

Treatment:

Device: Patient-controlled analgesia pump