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

Study Overview
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Brief Summary
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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).

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

Conditions
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Pain, Postoperative, Thoracic Surgery, Video-Assisted

Intervention / Treatment
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* Drug: Hydromorphone
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group M<br>Drug: Morphine Background: No Bolus infusion: 0.015 mg*kg-1 | Drug: Morphine<br>* 0.015 mg*kg-1 bolus without background infusion for group M Drug is administered through PCIA pump.<br>|
| Experimental: Group NBH<br>Drug: Hydromorphone Background: No Bolus infusion: 0.002 mg*kg-1 | Drug: Hydromorphone<br>* 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.<br>|
| Experimental: Group BH<br>Drug: Hydromorphone Background: 0.002 mg*kg-1*h-1 Bolus infusion: 0.002 mg*kg-1 | Drug: Hydromorphone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

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