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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03648008

Enrollment

171

Registered

2018-08-27

Start date

2018-05-05

Completion date

2018-09-01

Last updated

2018-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Thoracic Surgery, Video-Assisted

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).

Interventions

DRUGHydromorphone

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.

DRUGMorphine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Secondary

Measure	Time frame	Description
Ratio of Vomiting	8 p.m. at surgery day	Record whether patients experience vomiting and how many times do they experience
Total Analgesia usage	8 p.m. at surgery day	Sum up any extra analgesia when analgesic failure (VAS persistently \> 4) with PCIA pump
Total Antiemetic usage	8 p.m. at surgery day	Sum up any antiemetic
Ratio of Nausea	8 p.m. at surgery day	Record whether patients experience nausea

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Measure	Time frame	Description
Activity pain assessment at 8 p.m. at third day after surgery	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.
Activity pain assessment at 8 p.m. at second day after surgery	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.
Rest pain assessment at 8 a.m. at third day after surgery	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.
Activity pain assessment at 8 a.m. at third day after surgery	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.
Rest pain assessment at 8 p.m. at third day after surgery	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.
Rest pain assessment at 0.5 hour after tracheal extubation	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.
Rest pain assessment at 8 p.m. surgery day	8 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 day	8 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.
Rest pain assessment at 8 a.m. at first day after surgery	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.
Activity pain assessment at 8 a.m. at first day after surgery	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.
Rest pain assessment at 8 p.m. at first day after surgery	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.
Activity pain assessment at 8 p.m. at first day after surgery	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.
Rest pain assessment at 8 a.m. at second day after surgery	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.
Activity pain assessment at 8 a.m. at second day after surgery	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.
Rest pain assessment at 8 p.m. at second day after surgery	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.