Perioperative Analgesia Modes in Minimally Invasive Esophagectomy

March 17, 2025 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative pain score
Time Frame: 4 hours after surgery
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
Time Frame: 12 hours after surgery
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
Time Frame: 24 hours after surgery
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
Time Frame: 36 hours after surgery
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
Time Frame: 48 hours after surgery
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
Time Frame: 60 hours after surgery
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
Time Frame: 72 hours after surgery
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to first postoperative flatus
Time Frame: Up to 14 days after surgery
Time from the end of surgery to the first flatus.
Up to 14 days after surgery
Time to first postoperative defaecation
Time Frame: Up to 14 days after surgery
Time from the end of surgery to the first defaecation.
Up to 14 days after surgery
Abdominal distension score
Time Frame: 24 hours after surgery
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
Time Frame: 48 hours after surgery
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
Time Frame: 72 hours after surgery
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
Time Frame: 24 hours after surgery
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
Time Frame: 48 hours after surgery
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
Time Frame: 72 hours after surgery
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 Frame: Up to 14 days after surgery
Time from the end of surgery to the first postoperative ambulation
Up to 14 days after surgery
Hospital duration from operation to discharge
Time Frame: Up to 60 days after surgery
Time from the end of surgery to discharge from the hospital
Up to 60 days after surgery
Rate of pulmonary infection
Time Frame: Up to 30 days after surgery
Rate of pulmonary infection up to 30 days after surgery
Up to 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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