Perioperative Analgesia Modes in Minimally Invasive Esophagectomy

Chinese Academy of Medical Sciences & Peking Union Medical College logo

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)

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

Trial contacts and locations

1

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Central trial contact

zhu zhixiang

Data sourced from clinicaltrials.gov

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