Perioperative Analgesia Modes in Minimally Invasive Esophagectomy

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

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

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer; Patient-controlled Analgesia; NSAIDs; Perioperative Analgesia; Opioid
• Intervention / Treatment: Drug: Postoperative flurbiprofen axetil; Drug: Preemptive flurbiprofen axetil; Device: Patient-controlled analgesia pump

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: zhu zhixiang; Phone Number: 13311131231; Email: zhuzhixiang2010@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Cancer Hospital Chinese Academy of Medical Sciences
    • Contact: Yin Li, MD; Phone Number: 861087788052; Email: liyin@cicams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neurobehavioral Manifestations; Head and Neck Neoplasms; Esophageal Diseases; Perceptual Disorders; Esophageal Neoplasms; Agnosia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Flurbiprofen; Flurbiprofen axetil
• Other Study ID Numbers: 22/166-3367

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No