Clinical trial

Effect of Oxycodone Combined With Ultrasound Guided Thoracic Paravertebral Nerve Block on Postoperative Analgesia in Patients With Lung Cancer Undergoing Thoracoscopic Surgery

Name

YXLL-KY-2022(116)

Description

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.

Trial arms

Trial start

2023-03-01

Estimated PCD

2024-07-31

Trial end

2024-12-31

Status

Not yet recruiting

Phase

Early phase I

Treatment

Oxycodone 1mg/kg

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

Arms:

Test group 1(OCA group)

Other names:

Oxycodone

Oxycodone 1.5mg/kg

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

Arms:

Test group 2(OCB group)

Sufentanil

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

Arms:

Control group(SF group)

Size

159

Primary endpoint

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

at 24h after surgery

Eligibility criteria

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: 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 -

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 159, 'type': 'ESTIMATED'}}

Updated at

2023-02-23

1 organization

2 products

1 indication

Organization

Product

Indication

Product