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Trial Title:
Perioperative Analgesia Modes in Minimally Invasive Esophagectomy
NCT ID:
NCT05504265
Condition:
Esophageal Cancer
Perioperative Analgesia
NSAIDs
Opioid
Patient-controlled Analgesia
Conditions: Official terms:
Esophageal Neoplasms
Agnosia
Flurbiprofen
Flurbiprofen axetil
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Preemptive flurbiprofen axetil
Description:
50mg once，30min before induction anesthesia
Arm group label:
Preemptive analgesia followed by Postoperative NSAIDs
Intervention type:
Drug
Intervention name:
Postoperative flurbiprofen axetil
Description:
50mg bid
Arm group label:
Postoperative NSAIDs
Arm group label:
Preemptive analgesia followed by Postoperative NSAIDs
Intervention type:
Device
Intervention name:
Patient-controlled analgesia pump
Description:
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.
Arm group label:
Postoperative patient-controlled analgesia pump
Summary:
This study was designed to compare analgesic efficacy and safety of different
perioperative analgesic modes in minimally invasive esophagectomy for esophageal cancer.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Start date:
August 10, 2022
Completion date:
May 20, 2023
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05504265
