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Status unknownNCT05742256Updated Feb 23, 2023

Oxycodone in Combination With Parathoracic Nerve Block is Used for Postoperative Analgesia in Lung Cancer

A Phase 1 interventional study of Oxycodone 1mg/kg and Oxycodone 1.5mg/kg in Oxycodone, sponsored by Qianfoshan Hospital. Status unknown. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-02-23.

Sponsored by Qianfoshan Hospital · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

In this study, the effect of oxycodone combined with ultrasound-guided paravertebral nerve block on the postoperative analgesic effect of thoracoscopic lung cancer was investigated, and the effect and reasonable dose of oxycodone were explored, which provided a reference for the clinical multimodal analgesia after thoracoscopic lung cancer surgery.

02

Conditions studied

  • Oxycodone

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Keywords

  • Oxycodone
  • Postoperative analgesia
  • lung cancer
  • thoracic paravertebral nerve block
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 159 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Qianfoshan Hospital is the lead sponsor of 140 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female, age > 60 years
  2. Patients undergoing thoracoscopic lobectomy
  3. ASA (American Academy of Anesthesiologists) Grades I-III
  4. There were no obvious abnormalities in heart, liver, and kidney function
  5. Sign the informed consent form for this clinical study

Exclusion criteria

Exclusion Criteria:

  1. History of oxycodone or sufentanil allergy
  2. Renal or hepatic dysfunction
  3. History of drug or alcohol abuse
  4. Psychiatric disorders: schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis
  5. Those who have difficulty communicating due to coma, severe dementia, speech barrier, or those who cannot cooperate due to other diseases.
  6. People with head trauma or other brain diseases -
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
159 participants (estimated)

Study arms

  • Experimental
    Test group 1(OCA group)

    Drug: Oxycodone 1mg/kg

  • Experimental
    Test group 2(OCB group)

    Drug: Oxycodone 1.5mg/kg

  • Active comparator
    Control group(SF group)

    Drug: Sufentanil

Interventions

  • DrugOxycodone 1mg/kg

    Test group 1 (OCA group):oxycodone 1mg/kg + flurbiprofen 50mg + ondansetron 16mg + 0.9% normal saline diluted to 100ml

    Also known as: Oxycodone

  • DrugOxycodone 1.5mg/kg

    Test group 2 (OCB group): oxycodone 1.5mg/kg + flurbiprofen 50mg + ondansetron 16mg + 0.9% normal saline diluted to 100ml.

  • DrugSufentanil

    Control group (SF group): sufentanil 2ug/kg + flurbiprofen + ondansetron 16mg + 0.9% normal saline diluted to 100ml.

06

What researchers measure

Primary outcomes

  1. The main indicators were NRS scores at rest and cough at 24 h postoperatively.

    NRS (numerical rating scale) is composed of 11 numbers from 0 to 10, and patients use 11 numbers from 0 to 10 to describe the intensity of pain, and the higher the number, the more severe the pain.

    Time frame: at 24h after surgery

Secondary outcomes

  1. Time to double-lumen tracheal extraction

    Time to double-lumen tracheal extraction

    Time frame: Within two hours after surgery

  2. NRS score at rest and cough

    NRS (numerical rating scale) is composed of 11 numbers from 0 to 10, and patients use 11 numbers from 0 to 10 to describe the intensity of pain, and the higher the number, the more severe the pain.

    Time frame: at 2h , 4h, 12h, 48h after surgery

  3. sedation score (Ramsay sedation score)

    The Ramsay sedation score is the most widely used sedation scoring criterion in clinical practice. It is divided into six levels, reflecting three levels of wakefulness and three levels of sleep. The higher the level, the deeper the level of sedation.

    Time frame: at 2 h , 4 h , 12 h ,24 h,48 h postoperatively

  4. sufentanil consumption

    sufentanil consumption

    Time frame: Within 48 hours after surgery

  5. oxycodone consumption

    oxycodone consumption

    Time frame: Within 48 hours after surgery

  6. analgesic pump compressions

    analgesic pump compressions

    Time frame: Within 48 hours after surgery

  7. additional analgesic doses

    additional analgesic doses

    Time frame: Within 48 hours after surgery

  8. incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin

    incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin

    Time frame: Within 48 hours after surgery

  9. gastrointestinal recovery (exhaust time)

    gastrointestinal recovery (exhaust time)

    Time frame: Within 48 hours after surgery

  10. laboratory results of C-reactive protein 1 day before and after surgery

    laboratory results of C-reactive protein 1 day before and after surgery

    Time frame: Within 48 hours after surgery

  11. laboratory results of interleukin-6 laboratory test 1 day before and after surgery

    laboratory results of interleukin-6 laboratory test 1 day before and after surgery

    Time frame: Within 48 hours after surgery

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05742256
Lead sponsor
Qianfoshan Hospital
Responsible party
Pengcai Shi (Chief physician，Master Tutor, Qianfoshan Hospital) — Principal investigator
First posted
Feb 23, 2023
Start date
Mar 1, 2023 (estimated)
Primary completion
Jul 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Feb 23, 2023

Study contacts

Pengcai Shi, Chief physician
Contact
shipc1997@163.com
13791126828

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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