NCT03648008

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 26, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

August 13, 2018

Last Update Submit

September 24, 2018

Conditions

Pain, PostoperativeThoracic Surgery, Video-Assisted

Outcome Measures

Primary Outcomes (15)

  • 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 Outcomes (27)

  • Ratio of Nausea

    8 p.m. at surgery day

  • Ratio of Vomiting

    8 p.m. at surgery day

  • Ratio of Nausea

    8 a.m. at first day after surgery

  • Ratio of Vomiting

    8 a.m. at first day after surgery

  • Ratio of Nausea

    8 p.m. at first day after surgery

  • +22 more secondary outcomes

Study Arms (3)

Group M

ACTIVE COMPARATOR

Drug: Morphine Background: No Bolus infusion: 0.015 mg\*kg-1

Drug: Morphine

Group NBH

EXPERIMENTAL

Drug: Hydromorphone Background: No Bolus infusion: 0.002 mg\*kg-1

Drug: Hydromorphone

Group BH

EXPERIMENTAL

Drug: Hydromorphone Background: 0.002 mg\*kg-1\*h-1 Bolus infusion: 0.002 mg\*kg-1

Drug: Hydromorphone

Interventions

HydromorphoneDRUG

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.

Group BHGroup NBH
MorphineDRUG

0.015 mg\*kg-1 bolus without background infusion for group M Drug is administered through PCIA pump.

Group M

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

HydromorphoneMorphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Min Yan, Doctor

    Zhejiang University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 27, 2018

Study Start

May 5, 2018

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

September 26, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)