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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648008
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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).

Condition or disease Intervention/treatment Phase
Pain, Postoperative Thoracic Surgery, Video-Assisted Drug: Hydromorphone Drug: Morphine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Analgesic Effect of Hydromorphone on Chinese Patients Receiving Partial Pulmonary Resection Under Video-assisted Thoracoscopy
Actual Study Start Date : May 5, 2018
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.


Secondary Outcome Measures :
  1. Ratio of Nausea [ Time Frame: 8 p.m. at surgery day ]
    Record whether patients experience nausea

  2. Ratio of Vomiting [ Time Frame: 8 p.m. at surgery day ]
    Record whether patients experience vomiting and how many times do they experience

  3. Ratio of Nausea [ Time Frame: 8 a.m. at first day after surgery ]
    Record whether patients experience nausea

  4. 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

  5. Ratio of Nausea [ Time Frame: 8 p.m. at first day after surgery ]
    Record whether patients experience nausea

  6. 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

  7. Ratio of Nausea [ Time Frame: 8 a.m. at second day after surgery ]
    Record whether patients experience nausea

  8. 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

  9. Ratio of Nausea [ Time Frame: 8 p.m. at second day after surgery ]
    Record whether patients experience nausea

  10. 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

  11. Ratio of Nausea [ Time Frame: 8 a.m. at third day after surgery ]
    Record whether patients experience nausea

  12. 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

  13. Ratio of Nausea [ Time Frame: 8 p.m. at third day after surgery ]
    Record whether patients experience nausea

  14. 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

  15. 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

  16. Total Antiemetic usage [ Time Frame: 8 p.m. at surgery day ]
    Sum up any antiemetic

  17. 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

  18. Total Antiemetic usage [ Time Frame: 8 p.m. at first day after surgery ]
    Sum up any antiemetic from last time point

  19. 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

  20. 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

  21. Total Antiemetic usage [ Time Frame: 8 a.m. at second day after surgery ]
    Sum up any antiemetic from last time point

  22. 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

  23. Total Antiemetic usage [ Time Frame: 8 p.m. at second day after surgery ]
    Sum up any antiemetic from last time point

  24. 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

  25. Total Antiemetic usage [ Time Frame: 8 a.m. at third day after surgery ]
    Sum up any antiemetic from last time point

  26. 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

  27. Total Antiemetic usage [ Time Frame: 8 p.m. at third day after surgery ]
    Sum up any antiemetic from last time point



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648008


Locations
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China, Zhejiang
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Chair: Min Yan, Doctor Zhejiang University
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03648008    
Other Study ID Numbers: 2018-014
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Morphine
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents