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

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

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).

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Thoracic Surgery, Video-Assisted
• Intervention / Treatment: Drug: Morphine; Drug: Hydromorphone

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2018
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine; Hydromorphone
• Other Study ID Numbers: 2018-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No