Perioperative Analgesia Modes in Minimally Invasive Esophagectomy

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

Official Title
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Comparison of Efficacy and Safety of Different Analgesic Modes in Minimally Invasive Esophagectomy for Esophageal Cancer

Conditions
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Esophageal Cancer, Perioperative Analgesia, NSAIDs, Opioid, Patient-controlled Analgesia

Intervention / Treatment
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* Drug: Preemptive flurbiprofen axetil
* Drug: Postoperative flurbiprofen axetil
* Device: Patient-controlled analgesia pump


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Postoperative NSAIDs<br> | Drug: Postoperative flurbiprofen axetil<br>* 50mg bid<br>|
| Experimental: Preemptive analgesia followed by Postoperative NSAIDs<br> | Drug: Preemptive flurbiprofen axetil<br>* 50mg once，30min before induction anesthesia<br>Drug: Postoperative flurbiprofen axetil<br>* 50mg bid<br>|
| Experimental: Postoperative patient-controlled analgesia pump<br> | Device: Patient-controlled analgesia pump<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score | 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. | 4 hours after surgery | 
| Postoperative pain score | 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. | 12 hours after surgery | 
| Postoperative pain score | 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. | 24 hours after surgery | 
| Postoperative pain score | 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. | 36 hours after surgery | 
| Postoperative pain score | 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. | 48 hours after surgery | 
| Postoperative pain score | 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. | 60 hours after surgery | 
| Postoperative pain score | 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. | 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first postoperative flatus | Time from the end of surgery to the first flatus. | Up to 14 days after surgery | 
| Time to first postoperative defaecation | Time from the end of surgery to the first defaecation. | Up to 14 days after surgery | 
| Abdominal distension score | 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. | 24 hours after surgery | 
| Abdominal distension score | 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. | 48 hours after surgery | 
| Abdominal distension score | 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. | 72 hours after surgery | 
| Side effects related to opioids | Nausea and vomiting were measured using a scoring system(0 = no nausea, 1 = only nausea, 2 = both nausea and vomiting). | 24 hours after surgery | 
| Side effects related to opioids | Nausea and vomiting were measured using a scoring system(0 = no nausea, 1 = only nausea, 2 = both nausea and vomiting). | 48 hours after surgery | 
| Side effects related to opioids | Nausea and vomiting were measured using a scoring system(0 = no nausea, 1 = only nausea, 2 = both nausea and vomiting). | 72 hours after surgery | 
| Time to first postoperative ambulation | Time from the end of surgery to the first postoperative ambulation | Up to 14 days after surgery | 
| Hospital duration from operation to discharge | Time from the end of surgery to discharge from the hospital | Up to 60 days after surgery | 
| Rate of pulmonary infection | Rate of pulmonary infection up to 30 days after surgery | Up to 30 days after surgery |