MedPath

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

Phase 4
Completed
Conditions
Thoracic Surgery, Video-Assisted
Pain, Postoperative
Interventions
Registration Number
NCT03648008
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
171
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group MMorphineDrug: Morphine Background: No Bolus infusion: 0.015 mg\*kg-1
Group NBHHydromorphoneDrug: Hydromorphone Background: No Bolus infusion: 0.002 mg\*kg-1
Group BHHydromorphoneDrug: Hydromorphone Background: 0.002 mg\*kg-1\*h-1 Bolus infusion: 0.002 mg\*kg-1
Primary Outcome Measures
NameTimeMethod
Rest pain assessment at 8 a.m. at first day after surgery8 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.

Activity pain assessment at 8 a.m. at first day after surgery8 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.

Rest pain assessment at 8 a.m. at second day after surgery8 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.

Activity pain assessment at 8 p.m. at third day after surgery8 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.

Rest pain assessment at 0.5 hour after tracheal extubation0.5 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.

Activity pain assessment at 8 p.m. at second day after surgery8 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.

Activity pain assessment at 8 a.m. at third day after surgery8 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.

Rest pain assessment at 8 p.m. surgery day8 p.m. at 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.

Activity pain assessment at 8 p.m. surgery day8 p.m. at 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.

Activity pain assessment at 8 a.m. at second day after surgery8 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.

Rest pain assessment at 8 p.m. at second day after surgery8 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.

Rest pain assessment at 8 p.m. at third day after surgery8 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.

Rest pain assessment at 8 p.m. at first day after surgery8 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.

Activity pain assessment at 8 p.m. at first day after surgery8 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.

Rest pain assessment at 8 a.m. at third day after surgery8 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.

Secondary Outcome Measures
NameTimeMethod
Total Analgesia usage8 p.m. at third day after surgery

Sum up any extra analgesia when analgesic failure (VAS persistently \> 4) with PCIA pump from last time point

Ratio of Nausea8 p.m. at third day after surgery

Record whether patients experience nausea

Ratio of Vomiting8 p.m. at third day after surgery

Record whether patients experience vomiting and how many times do they experience

Total Antiemetic usage8 p.m. at third day after surgery

Sum up any antiemetic from last time point

Trial Locations

Locations (1)

The second affiliated hospital of Zhejiang University

🇨🇳

Hangzhou, Zhejiang, China

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