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Completed

NCT Number: NCT03648008

Postoperative Analgesic Effect of Hydromorphone on 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).

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Thoracic Surgery, Video-Assisted

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydromorphone

Drug

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.

Morphine

Drug

0.015 mg*kg-1 bolus without background infusion for group M Drug is administered through PCIA pump.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 27, 2018
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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