Perioperative Analgesia Modes in Minimally Invasive Esophagectomy

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05504265
• Other study ID #: 22/166-3367
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: August 10, 2022
• Est. completion date: May 20, 2023

Study information

• Verified date: August 2022
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: zhu zhixiang
• Phone: 13311131231
• Email: zhuzhixiang2010[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: May 20, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• NSAIDs
• Opioid
• Patient-controlled Analgesia
• Perioperative Analgesia

Intervention

Drug:
• Preemptive flurbiprofen axetil
50mg once,30min before induction anesthesia
• Postoperative flurbiprofen axetil
50mg bid

Device:
• Patient-controlled analgesia pump
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.

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Time to first postoperative flatus	Time from the end of surgery to the first flatus.	Up to 14 days after surgery
Secondary	Time to first postoperative defaecation	Time from the end of surgery to the first defaecation.	Up to 14 days after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to first postoperative ambulation	Time from the end of surgery to the first postoperative ambulation	Up to 14 days after surgery
Secondary	Hospital duration from operation to discharge	Time from the end of surgery to discharge from the hospital	Up to 60 days after surgery
Secondary	Rate of pulmonary infection	Rate of pulmonary infection up to 30 days after surgery	Up to 30 days after surgery