Perioperative Analgesia Modes in Minimally Invasive Esophagectomy

Phase 2

Recruiting

• Conditions: Patient-controlled Analgesia; NSAIDs; Opioid; Esophageal Cancer; Perioperative Analgesia
• Interventions: Device: Patient-controlled analgesia pump; Drug: Preemptive flurbiprofen axetil; Drug: Postoperative flurbiprofen axetil

• Registration Number: NCT05504265
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Study Start: 2022-10-10
• Status Verified: 2024-07
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preemptive analgesia followed by Postoperative NSAIDs	Postoperative flurbiprofen axetil	-
Postoperative patient-controlled analgesia pump	Patient-controlled analgesia pump	-
Postoperative NSAIDs	Postoperative flurbiprofen axetil	-
Preemptive analgesia followed by Postoperative NSAIDs	Preemptive flurbiprofen axetil	-

Primary Outcome Measures

Name	Time	Method
Postoperative pain score	72 hours after surgery	In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.

Secondary Outcome Measures

Name	Time	Method
Time to first postoperative flatus	Up to 14 days after surgery	Time from the end of surgery to the first flatus.
Time to first postoperative defaecation	Up to 14 days after surgery	Time from the end of surgery to the first defaecation.
Abdominal distension score	72 hours after surgery	Abdominal distension was measured using a scoring system, '0' is the minimum value that indicates no abdominal distension, while '10' is the maximum value that defines the most severe abdominal distension.
Side effects related to opioids	72 hours after surgery	Nausea and vomiting were measured using a scoring system(0 = no nausea, 1 = only nausea, 2 = both nausea and vomiting).
Time to first postoperative ambulation	Up to 14 days after surgery	Time from the end of surgery to the first postoperative ambulation
Hospital duration from operation to discharge	Up to 60 days after surgery	Time from the end of surgery to discharge from the hospital
Rate of pulmonary infection	Up to 30 days after surgery	Rate of pulmonary infection up to 30 days after surgery

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China