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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03648008
Other study ID # 2018-014
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 5, 2018
Est. completion date September 1, 2018

Study information

Verified date August 2018
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 171
Est. completion date September 1, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China The second affiliated hospital of Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 0.5 hour after tracheal extubation
Primary 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. 8 p.m. at surgery day
Primary 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. 8 p.m. at surgery day
Primary 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. 8 a.m. at first day after surgery
Primary 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. 8 a.m. at first day after surgery
Primary 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. 8 p.m. at first day after surgery
Primary 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. 8 p.m. at first day after surgery
Primary 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. 8 a.m. at second day after surgery
Primary 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. 8 a.m. at second day after surgery
Primary 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. 8 p.m. at second day after surgery
Primary 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. 8 p.m. at second day after surgery
Primary 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. 8 a.m. at third day after surgery
Primary 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. 8 a.m. at third day after surgery
Primary 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. 8 p.m. at third day after surgery
Primary 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. 8 p.m. at third day after surgery
Secondary Ratio of Nausea Record whether patients experience nausea 8 p.m. at surgery day
Secondary Ratio of Vomiting Record whether patients experience vomiting and how many times do they experience 8 p.m. at surgery day
Secondary Ratio of Nausea Record whether patients experience nausea 8 a.m. at first day after surgery
Secondary Ratio of Vomiting Record whether patients experience vomiting and how many times do they experience 8 a.m. at first day after surgery
Secondary Ratio of Nausea Record whether patients experience nausea 8 p.m. at first day after surgery
Secondary Ratio of Vomiting Record whether patients experience vomiting and how many times do they experience 8 p.m. at first day after surgery
Secondary Ratio of Nausea Record whether patients experience nausea 8 a.m. at second day after surgery
Secondary Ratio of Vomiting Record whether patients experience vomiting and how many times do they experience 8 a.m. at second day after surgery
Secondary Ratio of Nausea Record whether patients experience nausea 8 p.m. at second day after surgery
Secondary Ratio of Vomiting Record whether patients experience vomiting and how many times do they experience 8 p.m. at second day after surgery
Secondary Ratio of Nausea Record whether patients experience nausea 8 a.m. at third day after surgery
Secondary Ratio of Vomiting Record whether patients experience vomiting and how many times do they experience 8 a.m. at third day after surgery
Secondary Ratio of Nausea Record whether patients experience nausea 8 p.m. at third day after surgery
Secondary Ratio of Vomiting Record whether patients experience vomiting and how many times do they experience 8 p.m. at third day after surgery
Secondary Total Analgesia usage Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump 8 p.m. at surgery day
Secondary Total Antiemetic usage Sum up any antiemetic 8 p.m. at surgery day
Secondary Total Analgesia usage 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
Secondary Total Antiemetic usage Sum up any antiemetic from last time point 8 p.m. at first day after surgery
Secondary Total Analgesia usage 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
Secondary Total Analgesia usage 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
Secondary Total Antiemetic usage Sum up any antiemetic from last time point 8 a.m. at second day after surgery
Secondary Total Analgesia usage 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
Secondary Total Antiemetic usage Sum up any antiemetic from last time point 8 p.m. at second day after surgery
Secondary Total Analgesia usage 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
Secondary Total Antiemetic usage Sum up any antiemetic from last time point 8 a.m. at third day after surgery
Secondary Total Analgesia usage 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
Secondary Total Antiemetic usage Sum up any antiemetic from last time point 8 p.m. at third day after surgery
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