Esophageal Cancer, NSAIDs, Opioid, Patient-controlled Analgesia, Perioperative Analgesia
Conditions
Brief summary
This study was designed to compare analgesic efficacy and safety of different perioperative analgesic modes in minimally invasive esophagectomy for esophageal cancer.
Interventions
DRUGPreemptive flurbiprofen axetil
50mg once，30min before induction anesthesia
DRUGPostoperative flurbiprofen axetil
50mg bid
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.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score | 4 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
| Measure | Time frame | Description |
|---|---|---|
| Time to first postoperative defaecation | Up to 14 days after surgery | Time from the end of surgery to the first defaecation. |
| Abdominal distension score | 24 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 | 24 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 flatus | Up to 14 days after surgery | Time from the end of surgery to the first flatus. |
| 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 |
| Time to first postoperative ambulation | Up to 14 days after surgery | Time from the end of surgery to the first postoperative ambulation |
Countries
China
Contacts
Primary Contactzhu zhixiang
Outcome results
None listed