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

NCT05742256 | Unknown Phase 1 DMC

• 1 other identifier: YXLL-KY-2022(116)
• Study Type: interventional
• Target: 159
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Oxycodone

Keywords

Oxycodone; Postoperative analgesia; lung cancer; thoracic paravertebral nerve block

Outcome Measures

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.

  at 24h after surgery

Secondary Outcomes (11)

• Time to double-lumen tracheal extraction

  Within two hours after surgery

• NRS score at rest and cough

  at 2h , 4h, 12h, 48h after surgery

• sedation score (Ramsay sedation score)

  at 2 h , 4 h , 12 h ,24 h,48 h postoperatively

• sufentanil consumption

  Within 48 hours after surgery

• oxycodone consumption

  Within 48 hours after surgery

Study Arms (3)

Test group 1(OCA group)

EXPERIMENTAL

Drug: Oxycodone 1mg/kg

Test group 2(OCB group)

EXPERIMENTAL

Drug: Oxycodone 1.5mg/kg

Control group(SF group)

ACTIVE COMPARATOR

Drug: Sufentanil

Interventions

Oxycodone 1mg/kg DRUG

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

Also known as: Oxycodone

Test group 1(OCA group)

Oxycodone 1.5mg/kg DRUG

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

Test group 2(OCB group)

Sufentanil DRUG

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

Control group(SF group)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Related Publications (1)

• Wang Y, Wu G, Liu Z, Wei X, Feng H, Su J, Shi P. Effect of oxycodone combined with ultrasound-guided thoracic paravertebral nerve block on postoperative analgesia in patients with lung cancer undergoing thoracoscopic surgery: protocol for a randomised controlled study. BMJ Open. 2023 Oct 16;13(10):e074416. doi: 10.1136/bmjopen-2023-074416.

  PMID: 37844986 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Oxycodone; Sufentanil

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Pengcai Shi, Chief physician

CONTACT

13791126828; shipc1997@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician，Master Tutor

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 23, 2023
• Study Start: March 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 23, 2023

Record last verified: 2023-02