Clinical trial NCT03648008: Postoperative Analgesic Effect of Hydromorphone on Partial Pulmonary Resection Under Video-assisted Thoracoscopy
Official title: Postoperative Analgesic Effect of Hydromorphone on Chinese Patients Receiving Partial Pulmonary Resection Under Video-assisted Thoracoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Thoracic Surgery, Video-Assisted
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Rest pain assessment at 0.5 hour after tracheal extubation
timeFrame: 0.5 hour after tracheal extubation
measure: Rest pain assessment at 8 p.m. surgery day
timeFrame: 8 p.m. at surgery day
measure: Activity pain assessment at 8 p.m. surgery day
timeFrame: 8 p.m. at surgery day
measure: Rest pain assessment at 8 a.m. at first day after surgery
timeFrame: 8 a.m. at first day after surgery
measure: Activity pain assessment at 8 a.m. at first day after surgery
timeFrame: 8 a.m. at first day after surgery
measure: Rest pain assessment at 8 p.m. at first day after surgery
timeFrame: 8 p.m. at first day after surgery
measure: Activity pain assessment at 8 p.m. at first day after surgery
timeFrame: 8 p.m. at first day after surgery
measure: Rest pain assessment at 8 a.m. at second day after surgery
timeFrame: 8 a.m. at second day after surgery
measure: Activity pain assessment at 8 a.m. at second day after surgery
timeFrame: 8 a.m. at second day after surgery
measure: Rest pain assessment at 8 p.m. at second day after surgery
timeFrame: 8 p.m. at second day after surgery
measure: Activity pain assessment at 8 p.m. at second day after surgery
timeFrame: 8 p.m. at second day after surgery
measure: Rest pain assessment at 8 a.m. at third day after surgery
timeFrame: 8 a.m. at third day after surgery
measure: Activity pain assessment at 8 a.m. at third day after surgery
timeFrame: 8 a.m. at third day after surgery
measure: Rest pain assessment at 8 p.m. at third day after surgery
timeFrame: 8 p.m. at third day after surgery
measure: Activity pain assessment at 8 p.m. at third day after surgery
timeFrame: 8 p.m. at third day after surgery
Secondary outcomes:
measure: Ratio of Nausea
timeFrame: 8 p.m. at surgery day
measure: Ratio of Vomiting
timeFrame: 8 p.m. at surgery day
measure: Ratio of Nausea
timeFrame: 8 a.m. at first day after surgery
measure: Ratio of Vomiting
timeFrame: 8 a.m. at first day after surgery
measure: Ratio of Nausea
timeFrame: 8 p.m. at first day after surgery
measure: Ratio of Vomiting
timeFrame: 8 p.m. at first day after surgery
measure: Ratio of Nausea
timeFrame: 8 a.m. at second day after surgery
measure: Ratio of Vomiting
timeFrame: 8 a.m. at second day after surgery
measure: Ratio of Nausea
timeFrame: 8 p.m. at second day after surgery
measure: Ratio of Vomiting
timeFrame: 8 p.m. at second day after surgery
measure: Ratio of Nausea
timeFrame: 8 a.m. at third day after surgery
measure: Ratio of Vomiting
timeFrame: 8 a.m. at third day after surgery
measure: Ratio of Nausea
timeFrame: 8 p.m. at third day after surgery
measure: Ratio of Vomiting
timeFrame: 8 p.m. at third day after surgery
measure: Total Analgesia usage
timeFrame: 8 p.m. at surgery day
measure: Total Antiemetic usage
timeFrame: 8 p.m. at surgery day
measure: Total Analgesia usage
timeFrame: 8 a.m. at first day after surgery
measure: Total Antiemetic usage
timeFrame: 8 p.m. at first day after surgery
measure: Total Analgesia usage
timeFrame: 8 p.m. at first day after surgery
measure: Total Analgesia usage
timeFrame: 8 a.m. at second day after surgery
measure: Total Antiemetic usage
timeFrame: 8 a.m. at second day after surgery
measure: Total Analgesia usage
timeFrame: 8 p.m. at second day after surgery
measure: Total Antiemetic usage
timeFrame: 8 p.m. at second day after surgery
measure: Total Analgesia usage
timeFrame: 8 a.m. at third day after surgery
measure: Total Antiemetic usage
timeFrame: 8 a.m. at third day after surgery
measure: Total Analgesia usage
timeFrame: 8 p.m. at third day after surgery
measure: Total Antiemetic usage
timeFrame: 8 p.m. at third day after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Min Yan, Doctor
role: STUDY_CHAIR
References: