Perioperative Analgesia Modes in Minimally Invasive Esophagectomy

NCT ID: NCT05504265

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2025-12-20

Brief Summary

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Postoperative NSAIDs

Group Type: OTHER

Postoperative flurbiprofen axetil

Intervention Type: DRUG

50mg bid

Preemptive analgesia followed by Postoperative NSAIDs

Group Type: EXPERIMENTAL

Preemptive flurbiprofen axetil

Intervention Type: DRUG

50mg once，30min before induction anesthesia

Postoperative flurbiprofen axetil

Intervention Type: DRUG

50mg bid

Postoperative patient-controlled analgesia pump

Group Type: EXPERIMENTAL

Patient-controlled analgesia pump

Intervention Type: DEVICE

Sufentanil 2.5 μg/kg+ondansetron 8mg, prepared to 100ml normal saline; background dose: 2 ml/h, single press analgesic pump injection volume: 0.5 ml, locking time: 15 min.

Interventions

Preemptive flurbiprofen axetil

50mg once，30min before induction anesthesia

Intervention Type: DRUG

Postoperative flurbiprofen axetil

50mg bid

Intervention Type: DRUG

Patient-controlled analgesia pump

Sufentanil 2.5 μg/kg+ondansetron 8mg, prepared to 100ml normal saline; background dose: 2 ml/h, single press analgesic pump injection volume: 0.5 ml, locking time: 15 min.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

zhu zhixiang

Role: CONTACT

zhuzhixiang2010@163.com

13311131231

Facility Contacts

Yin Li, MD

Role: primary

liyin@cicams.ac.cn

861087788052

Other Identifiers

22/166-3367

Identifier Type: -

Identifier Source: org_study_id