Pain, Postoperative Clinical Trial
Official title:
Postoperative Analgesic Effect of Hydromorphone on Chinese Patients Receiving Partial Pulmonary Resection Under Video-assisted Thoracoscopy
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 |
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).
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 |
Country | Name | City | State |
---|---|---|---|
China | The second affiliated hospital of Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
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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