Back to resultsPostoperative Analgesic Effect of Hydromorphone on Partial Pulmonary Resection Under Video-assisted Thoracoscopy
Primary Purpose
Pain, Postoperative, Thoracic Surgery, Video-Assisted
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Hydromorphone
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
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
Sites / Locations
- The second affiliated hospital of Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Group M
Group NBH
Group BH
Arm Description
Drug: Morphine Background: No Bolus infusion: 0.015 mg*kg-1
Drug: Hydromorphone Background: No Bolus infusion: 0.002 mg*kg-1
Drug: Hydromorphone Background: 0.002 mg*kg-1*h-1 Bolus infusion: 0.002 mg*kg-1
Outcomes
Primary Outcome Measures
Rest pain assessment at 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.
Rest pain assessment at 8 p.m. 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.
Activity pain assessment at 8 p.m. 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.
Rest pain assessment at 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.
Activity pain assessment at 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.
Rest pain assessment at 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.
Activity pain assessment at 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.
Rest pain assessment at 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.
Activity pain assessment at 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.
Rest pain assessment at 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.
Activity pain assessment at 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.
Rest pain assessment at 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.
Activity pain assessment at 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.
Rest pain assessment at 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.
Activity pain assessment at 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.
Secondary Outcome Measures
Ratio of Nausea
Record whether patients experience nausea
Ratio of Vomiting
Record whether patients experience vomiting and how many times do they experience
Ratio of Nausea
Record whether patients experience nausea
Ratio of Vomiting
Record whether patients experience vomiting and how many times do they experience
Ratio of Nausea
Record whether patients experience nausea
Ratio of Vomiting
Record whether patients experience vomiting and how many times do they experience
Ratio of Nausea
Record whether patients experience nausea
Ratio of Vomiting
Record whether patients experience vomiting and how many times do they experience
Ratio of Nausea
Record whether patients experience nausea
Ratio of Vomiting
Record whether patients experience vomiting and how many times do they experience
Ratio of Nausea
Record whether patients experience nausea
Ratio of Vomiting
Record whether patients experience vomiting and how many times do they experience
Ratio of Nausea
Record whether patients experience nausea
Ratio of Vomiting
Record whether patients experience vomiting and how many times do they experience
Total Analgesia usage
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump
Total Antiemetic usage
Sum up any antiemetic
Total Analgesia usage
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Total Antiemetic usage
Sum up any antiemetic from last time point
Total Analgesia usage
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Total Analgesia usage
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Total Antiemetic usage
Sum up any antiemetic from last time point
Total Analgesia usage
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Total Antiemetic usage
Sum up any antiemetic from last time point
Total Analgesia usage
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Total Antiemetic usage
Sum up any antiemetic from last time point
Total Analgesia usage
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Total Antiemetic usage
Sum up any antiemetic from last time point
Full Information
NCT ID
NCT03648008
First Posted
August 13, 2018
Last Updated
September 24, 2018
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT03648008
Brief Title
Postoperative Analgesic Effect of Hydromorphone on Partial Pulmonary Resection Under Video-assisted Thoracoscopy
Official Title
Postoperative Analgesic Effect of Hydromorphone on Chinese Patients Receiving Partial Pulmonary Resection Under Video-assisted Thoracoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 5, 2018 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Thoracic Surgery, Video-Assisted
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
171 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group M
Arm Type
Active Comparator
Arm Description
Drug: Morphine Background: No Bolus infusion: 0.015 mg*kg-1
Arm Title
Group NBH
Arm Type
Experimental
Arm Description
Drug: Hydromorphone Background: No Bolus infusion: 0.002 mg*kg-1
Arm Title
Group BH
Arm Type
Experimental
Arm Description
Drug: Hydromorphone Background: 0.002 mg*kg-1*h-1 Bolus infusion: 0.002 mg*kg-1
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
0.015 mg*kg-1 bolus without background infusion for group M Drug is administered through PCIA pump.
Primary Outcome Measure Information:
Title
Rest pain assessment at 0.5 hour after tracheal extubation
Description
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.
Time Frame
0.5 hour after tracheal extubation
Title
Rest pain assessment at 8 p.m. surgery day
Description
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.
Time Frame
8 p.m. at surgery day
Title
Activity pain assessment at 8 p.m. surgery day
Description
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.
Time Frame
8 p.m. at surgery day
Title
Rest pain assessment at 8 a.m. at first day after surgery
Description
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.
Time Frame
8 a.m. at first day after surgery
Title
Activity pain assessment at 8 a.m. at first day after surgery
Description
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.
Time Frame
8 a.m. at first day after surgery
Title
Rest pain assessment at 8 p.m. at first day after surgery
Description
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.
Time Frame
8 p.m. at first day after surgery
Title
Activity pain assessment at 8 p.m. at first day after surgery
Description
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.
Time Frame
8 p.m. at first day after surgery
Title
Rest pain assessment at 8 a.m. at second day after surgery
Description
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.
Time Frame
8 a.m. at second day after surgery
Title
Activity pain assessment at 8 a.m. at second day after surgery
Description
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.
Time Frame
8 a.m. at second day after surgery
Title
Rest pain assessment at 8 p.m. at second day after surgery
Description
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.
Time Frame
8 p.m. at second day after surgery
Title
Activity pain assessment at 8 p.m. at second day after surgery
Description
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.
Time Frame
8 p.m. at second day after surgery
Title
Rest pain assessment at 8 a.m. at third day after surgery
Description
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.
Time Frame
8 a.m. at third day after surgery
Title
Activity pain assessment at 8 a.m. at third day after surgery
Description
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.
Time Frame
8 a.m. at third day after surgery
Title
Rest pain assessment at 8 p.m. at third day after surgery
Description
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.
Time Frame
8 p.m. at third day after surgery
Title
Activity pain assessment at 8 p.m. at third day after surgery
Description
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.
Time Frame
8 p.m. at third day after surgery
Secondary Outcome Measure Information:
Title
Ratio of Nausea
Description
Record whether patients experience nausea
Time Frame
8 p.m. at surgery day
Title
Ratio of Vomiting
Description
Record whether patients experience vomiting and how many times do they experience
Time Frame
8 p.m. at surgery day
Title
Ratio of Nausea
Description
Record whether patients experience nausea
Time Frame
8 a.m. at first day after surgery
Title
Ratio of Vomiting
Description
Record whether patients experience vomiting and how many times do they experience
Time Frame
8 a.m. at first day after surgery
Title
Ratio of Nausea
Description
Record whether patients experience nausea
Time Frame
8 p.m. at first day after surgery
Title
Ratio of Vomiting
Description
Record whether patients experience vomiting and how many times do they experience
Time Frame
8 p.m. at first day after surgery
Title
Ratio of Nausea
Description
Record whether patients experience nausea
Time Frame
8 a.m. at second day after surgery
Title
Ratio of Vomiting
Description
Record whether patients experience vomiting and how many times do they experience
Time Frame
8 a.m. at second day after surgery
Title
Ratio of Nausea
Description
Record whether patients experience nausea
Time Frame
8 p.m. at second day after surgery
Title
Ratio of Vomiting
Description
Record whether patients experience vomiting and how many times do they experience
Time Frame
8 p.m. at second day after surgery
Title
Ratio of Nausea
Description
Record whether patients experience nausea
Time Frame
8 a.m. at third day after surgery
Title
Ratio of Vomiting
Description
Record whether patients experience vomiting and how many times do they experience
Time Frame
8 a.m. at third day after surgery
Title
Ratio of Nausea
Description
Record whether patients experience nausea
Time Frame
8 p.m. at third day after surgery
Title
Ratio of Vomiting
Description
Record whether patients experience vomiting and how many times do they experience
Time Frame
8 p.m. at third day after surgery
Title
Total Analgesia usage
Description
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump
Time Frame
8 p.m. at surgery day
Title
Total Antiemetic usage
Description
Sum up any antiemetic
Time Frame
8 p.m. at surgery day
Title
Total Analgesia usage
Description
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Time Frame
8 a.m. at first day after surgery
Title
Total Antiemetic usage
Description
Sum up any antiemetic from last time point
Time Frame
8 p.m. at first day after surgery
Title
Total Analgesia usage
Description
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Time Frame
8 p.m. at first day after surgery
Title
Total Analgesia usage
Description
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Time Frame
8 a.m. at second day after surgery
Title
Total Antiemetic usage
Description
Sum up any antiemetic from last time point
Time Frame
8 a.m. at second day after surgery
Title
Total Analgesia usage
Description
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Time Frame
8 p.m. at second day after surgery
Title
Total Antiemetic usage
Description
Sum up any antiemetic from last time point
Time Frame
8 p.m. at second day after surgery
Title
Total Analgesia usage
Description
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Time Frame
8 a.m. at third day after surgery
Title
Total Antiemetic usage
Description
Sum up any antiemetic from last time point
Time Frame
8 a.m. at third day after surgery
Title
Total Analgesia usage
Description
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Time Frame
8 p.m. at third day after surgery
Title
Total Antiemetic usage
Description
Sum up any antiemetic from last time point
Time Frame
8 p.m. at third day after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Yan, Doctor
Organizational Affiliation
Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
The second affiliated hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Postoperative Analgesic Effect of Hydromorphone on Partial Pulmonary Resection Under Video-assisted Thoracoscopy
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