Clinical trial NCT05504265: Perioperative Analgesia Modes in Minimally Invasive Esophagectomy
Official title: Comparison of Efficacy and Safety of Different Analgesic Modes in Minimally Invasive Esophagectomy for Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Esophageal Cancer
Perioperative Analgesia
NSAIDs
Opioid
Patient-controlled Analgesia
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Postoperative pain score
timeFrame: 4 hours after surgery
measure: Postoperative pain score
timeFrame: 12 hours after surgery
measure: Postoperative pain score
timeFrame: 24 hours after surgery
measure: Postoperative pain score
timeFrame: 36 hours after surgery
measure: Postoperative pain score
timeFrame: 48 hours after surgery
measure: Postoperative pain score
timeFrame: 60 hours after surgery
measure: Postoperative pain score
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: Time to first postoperative flatus
timeFrame: Up to 14 days after surgery
measure: Time to first postoperative defaecation
timeFrame: Up to 14 days after surgery
measure: Abdominal distension score
timeFrame: 24 hours after surgery
measure: Abdominal distension score
timeFrame: 48 hours after surgery
measure: Abdominal distension score
timeFrame: 72 hours after surgery
measure: Side effects related to opioids
timeFrame: 24 hours after surgery
measure: Side effects related to opioids
timeFrame: 48 hours after surgery
measure: Side effects related to opioids
timeFrame: 72 hours after surgery
measure: Time to first postoperative ambulation
timeFrame: Up to 14 days after surgery
measure: Hospital duration from operation to discharge
timeFrame: Up to 60 days after surgery
measure: Rate of pulmonary infection
timeFrame: Up to 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
Study officials:
References: