Postoperative Analgesic Effect of Hydromorphone on Partial Pulmonary Resection Under Video-assisted Thoracoscopy

September 24, 2018 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Postoperative Analgesic Effect of Hydromorphone on Chinese Patients Receiving Partial Pulmonary Resection Under Video-assisted Thoracoscopy

Postoperative pain remains relatively high within 48h for Chinese patients who receive video-assisted thoracoscopic surgery. Multimodal analgesia combines several agents and/or techniques to function on diverse nociceptive mechanisms to enhance pain relief and lessen side effect. Hydromorphone is a hydrogenated ketone of morphine and approximately 5-10 times more potent. There lacks about efficacy and efficiency of hydromorphone in electrical pump for patient controlled intravenous analgesic (PCIA).

Study Overview

Status

Status

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

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 (Actual)

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.
171

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 4

Contacts and Locations

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

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The Second Affiliated Hospital of Zhejiang University

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 70≥ Age ≥18
  • Selective operation lung section with video-assisted thoracic surgery (VATS)
  • III ≥ American Society of Anesthesiologists classification (ASA classification) ≥I
  • Patients informed and agreed to join the study

Exclusion Criteria:

  • Abnormal function of liver and kidney
  • Allergic- dependence history of alcohol, opioids and Local anesthetics
  • No noncompliance
  • Mental disease history，language communication disorder，cicatricial diathesis
  • Underweight or overweight（BMI<18 or >30)
  • Patients not suitable for clinical subjects for other reasons
  • Sedatives, analgesics, antiemetic drugs and anti pruritus drugs were used within 24 hours before the operation.
  • History of previous abnormal anaesthesia
  • Women during pregnancy or lactation

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: Quadruple

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.
Active Comparator: Group M
Drug: Morphine Background: No Bolus infusion: 0.015 mg*kg-1
Drug: Morphine
0.015 mg*kg-1 bolus without background infusion for group M Drug is administered through PCIA pump.
Experimental: Group NBH
Drug: Hydromorphone Background: No Bolus infusion: 0.002 mg*kg-1
Drug: Hydromorphone
0.002 mg*kg-1 bolus with 0.002 mg*kg-1 background infusion for group BH 0.002 mg*kg-1 bolus without background infusion for group NBH Drug is administered through PCIA pump.
Experimental: Group BH
Drug: Hydromorphone Background: 0.002 mg*kg-1*h-1 Bolus infusion: 0.002 mg*kg-1
Drug: Hydromorphone
0.002 mg*kg-1 bolus with 0.002 mg*kg-1 background infusion for group BH 0.002 mg*kg-1 bolus without background infusion for group NBH Drug is administered through PCIA pump.

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
Rest pain assessment at 0.5 hour after tracheal extubation
Time Frame: 0.5 hour after tracheal extubation
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
0.5 hour after tracheal extubation
Rest pain assessment at 8 p.m. surgery day
Time Frame: 8 p.m. at surgery day
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
8 p.m. at surgery day
Activity pain assessment at 8 p.m. surgery day
Time Frame: 8 p.m. at surgery day
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
8 p.m. at surgery day
Rest pain assessment at 8 a.m. at first day after surgery
Time Frame: 8 a.m. at first day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
8 a.m. at first day after surgery
Activity pain assessment at 8 a.m. at first day after surgery
Time Frame: 8 a.m. at first day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
8 a.m. at first day after surgery
Rest pain assessment at 8 p.m. at first day after surgery
Time Frame: 8 p.m. at first day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
8 p.m. at first day after surgery
Activity pain assessment at 8 p.m. at first day after surgery
Time Frame: 8 p.m. at first day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
8 p.m. at first day after surgery
Rest pain assessment at 8 a.m. at second day after surgery
Time Frame: 8 a.m. at second day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
8 a.m. at second day after surgery
Activity pain assessment at 8 a.m. at second day after surgery
Time Frame: 8 a.m. at second day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
8 a.m. at second day after surgery
Rest pain assessment at 8 p.m. at second day after surgery
Time Frame: 8 p.m. at second day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
8 p.m. at second day after surgery
Activity pain assessment at 8 p.m. at second day after surgery
Time Frame: 8 p.m. at second day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
8 p.m. at second day after surgery
Rest pain assessment at 8 a.m. at third day after surgery
Time Frame: 8 a.m. at third day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
8 a.m. at third day after surgery
Activity pain assessment at 8 a.m. at third day after surgery
Time Frame: 8 a.m. at third day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
8 a.m. at third day after surgery
Rest pain assessment at 8 p.m. at third day after surgery
Time Frame: 8 p.m. at third day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
8 p.m. at third day after surgery
Activity pain assessment at 8 p.m. at third day after surgery
Time Frame: 8 p.m. at third day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
8 p.m. at third day 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
Ratio of Nausea
Time Frame: 8 p.m. at surgery day
Record whether patients experience nausea
8 p.m. at surgery day
Ratio of Vomiting
Time Frame: 8 p.m. at surgery day
Record whether patients experience vomiting and how many times do they experience
8 p.m. at surgery day
Ratio of Nausea
Time Frame: 8 a.m. at first day after surgery
Record whether patients experience nausea
8 a.m. at first day after surgery
Ratio of Vomiting
Time Frame: 8 a.m. at first day after surgery
Record whether patients experience vomiting and how many times do they experience
8 a.m. at first day after surgery
Ratio of Nausea
Time Frame: 8 p.m. at first day after surgery
Record whether patients experience nausea
8 p.m. at first day after surgery
Ratio of Vomiting
Time Frame: 8 p.m. at first day after surgery
Record whether patients experience vomiting and how many times do they experience
8 p.m. at first day after surgery
Ratio of Nausea
Time Frame: 8 a.m. at second day after surgery
Record whether patients experience nausea
8 a.m. at second day after surgery
Ratio of Vomiting
Time Frame: 8 a.m. at second day after surgery
Record whether patients experience vomiting and how many times do they experience
8 a.m. at second day after surgery
Ratio of Nausea
Time Frame: 8 p.m. at second day after surgery
Record whether patients experience nausea
8 p.m. at second day after surgery
Ratio of Vomiting
Time Frame: 8 p.m. at second day after surgery
Record whether patients experience vomiting and how many times do they experience
8 p.m. at second day after surgery
Ratio of Nausea
Time Frame: 8 a.m. at third day after surgery
Record whether patients experience nausea
8 a.m. at third day after surgery
Ratio of Vomiting
Time Frame: 8 a.m. at third day after surgery
Record whether patients experience vomiting and how many times do they experience
8 a.m. at third day after surgery
Ratio of Nausea
Time Frame: 8 p.m. at third day after surgery
Record whether patients experience nausea
8 p.m. at third day after surgery
Ratio of Vomiting
Time Frame: 8 p.m. at third day after surgery
Record whether patients experience vomiting and how many times do they experience
8 p.m. at third day after surgery
Total Analgesia usage
Time Frame: 8 p.m. at surgery day
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump
8 p.m. at surgery day
Total Antiemetic usage
Time Frame: 8 p.m. at surgery day
Sum up any antiemetic
8 p.m. at surgery day
Total Analgesia usage
Time Frame: 8 a.m. at first day after surgery
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
8 a.m. at first day after surgery
Total Antiemetic usage
Time Frame: 8 p.m. at first day after surgery
Sum up any antiemetic from last time point
8 p.m. at first day after surgery
Total Analgesia usage
Time Frame: 8 p.m. at first day after surgery
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
8 p.m. at first day after surgery
Total Analgesia usage
Time Frame: 8 a.m. at second day after surgery
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
8 a.m. at second day after surgery
Total Antiemetic usage
Time Frame: 8 a.m. at second day after surgery
Sum up any antiemetic from last time point
8 a.m. at second day after surgery
Total Analgesia usage
Time Frame: 8 p.m. at second day after surgery
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
8 p.m. at second day after surgery
Total Antiemetic usage
Time Frame: 8 p.m. at second day after surgery
Sum up any antiemetic from last time point
8 p.m. at second day after surgery
Total Analgesia usage
Time Frame: 8 a.m. at third day after surgery
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
8 a.m. at third day after surgery
Total Antiemetic usage
Time Frame: 8 a.m. at third day after surgery
Sum up any antiemetic from last time point
8 a.m. at third day after surgery
Total Analgesia usage
Time Frame: 8 p.m. at third day after surgery
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
8 p.m. at third day after surgery
Total Antiemetic usage
Time Frame: 8 p.m. at third day after surgery
Sum up any antiemetic from last time point
8 p.m. at third day 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.
Second Affiliated Hospital, School of Medicine, Zhejiang University

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.
May 5, 2018

Primary Completion (Actual)

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 1, 2018

Study Completion (Actual)

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.
September 1, 2018

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).
August 13, 2018

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 23, 2018

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 27, 2018

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.
September 26, 2018

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.
September 24, 2018

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.
August 1, 2018

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.
  • 2018-014

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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