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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648008
• Other study ID #: 2018-014
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Thoracic Surgery, Video-Assisted

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