Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 75Years
All Genders
ID05504265

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

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-03-20

102

Participants Needed

1

Research Sites

11 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the pain relief effectiveness and safety of different pain management methods during and after minimally invasive esophagectomy surgery for esophageal cancer. This clinical trial compares various perioperative analgesic approaches to understand their impact on patient comfort and recovery. The study is conducted by the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, and spans phases 2 and 3 of clinical research. Participants will be randomly assigned to one of three groups: postoperative NSAIDs alone, preemptive analgesia followed by postoperative NSAIDs, or use of a postoperative patient-controlled analgesia pump. The preemptive analgesia involves a single 50mg dose of flurbiprofen axetil given 30 minutes before anesthesia. The NSAIDs are given at 50mg twice daily after surgery. The analgesia pump delivers sufentanil and ondansetron in a controlled dose. These treatments are compared to assess their pain control effects during the perioperative period. During the study, pain scores will be recorded at multiple time points up to 72 hours after surgery, alongside assessments of bowel function, abdominal discomfort, opioid-related side effects, early mobility, hospital stay length, and infection rates. Participants will be monitored closely for safety and recovery outcomes. The total participation duration and follow-up extend through the immediate postoperative period and up to 60 days after surgery to capture relevant health events and recovery progress.

CONDITIONS

Brief Title

Perioperative Analgesia Modes in Minimally Invasive Esophagectomy

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Undergoing laparoscopic, thoracoscopic, or robotic-assisted minimally invasive esophagectomy
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • History of cholecystitis or urolithiasis within the past 3 months
  • History of atherothrombosis, stroke, or myocardial infarction
  • Presence of lung diseases such as pneumonia, atelectasis, emphysema, or pulmonary bullae
  • Preoperative cardiac function grade III or higher or coronary artery stenosis
  • Preoperative indwelling thoracic drainage tube
  • Long-term heavy alcohol use (men: more than 4 drinks any day or 14 drinks per week; women: more than 3 drinks any day or 7 drinks per week)
  • Opioid tolerance defined as taking certain opioid doses for a week or longer
  • Painful skin complications like rashes or blisters
  • Conversion to open surgery
  • Limited postoperative ventilation function or endotracheal intubation lasting more than 24 hours

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 days after surgery

Participants receive analgesic treatments around the time of minimally invasive esophagectomy, including preemptive and postoperative drug therapies or patient-controlled analgesia pumps.

Visits for pain assessment at 4, 12, 24, 36, 48, 60, and 72 hours after surgery

Follow-up

Duration - Up to 60 days after surgery

Participants are monitored for recovery outcomes such as time to first postoperative flatus, defecation, ambulation, and incidence of complications up to 60 days after surgery.

Periodic visits up to 60 days after surgery

Trial Site Locations

Total: 1 location

1

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Actively Recruiting

Loading map...

Research Team

Z

zhu zhixiang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Similar Trials

18F-AraG PET/CT as a Non-Invasive Imaging Biomarker for Chem...

Esophageal Cancer

Actively Recruiting

1 location

A Phase 1/2a Study Utilizing 64Cu-LNTH-1363S (64Cu Radiolabe...

Metastatic Sarcoma

Actively Recruiting

5 locations

A Phase 1/2 Open Label, Dose Escalation and Expansion Study ...

Advanced Solid Tumor

Actively Recruiting

27 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here