NCT05504265

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

March 20, 2025

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

July 18, 2022

Last Update Submit

March 17, 2025

Conditions

Esophageal CancerPerioperative AnalgesiaNSAIDsOpioidPatient-controlled Analgesia

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (11)

  • Time to first postoperative flatus

    Up to 14 days after surgery

  • Time to first postoperative defaecation

    Up to 14 days after surgery

  • Abdominal distension score

    24 hours after surgery

  • Abdominal distension score

    48 hours after surgery

  • Abdominal distension score

    72 hours after surgery

  • +6 more secondary outcomes

Study Arms (3)

Postoperative NSAIDs

OTHER
Drug: Postoperative flurbiprofen axetil

Preemptive analgesia followed by Postoperative NSAIDs

EXPERIMENTAL
Drug: Preemptive flurbiprofen axetilDrug: Postoperative flurbiprofen axetil

Postoperative patient-controlled analgesia pump

EXPERIMENTAL
Device: Patient-controlled analgesia pump

Interventions

Preemptive flurbiprofen axetilDRUG

50mg once，30min before induction anesthesia

Preemptive analgesia followed by Postoperative NSAIDs
Postoperative flurbiprofen axetilDRUG

50mg bid

Postoperative NSAIDsPreemptive analgesia followed by Postoperative NSAIDs
Patient-controlled analgesia pumpDEVICE

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.

Postoperative patient-controlled analgesia pump

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years;
  • Patients underwent laparoscopic and thoracoscopic or robotic-assisted minimally invasive esophagectomy ;
  • Informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Central Study Contacts

zhu zhixiang

CONTACT

13311131231zhuzhixiang2010@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2022

First Posted

August 17, 2022

Study Start

October 10, 2022

Primary Completion

September 30, 2025

Study Completion

December 20, 2025

Last Updated

March 20, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)