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

Oxycodone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05742256
• Other study ID #: YXLL-KY-2022(116)
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Qianfoshan Hospital
• Contact: Pengcai Shi, Chief physician
• Phone: 13791126828
• Email: shipc1997[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 159
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Lung Neoplasms
• Oxycodone

Intervention

Drug:
• Oxycodone 1mg/kg
Test group 1 (OCA group):oxycodone 1mg/kg + flurbiprofen 50mg + ondansetron 16mg + 0.9% normal saline diluted to 100ml
• Oxycodone 1.5mg/kg
Test group 2 (OCB group): oxycodone 1.5mg/kg + flurbiprofen 50mg + ondansetron 16mg + 0.9% normal saline diluted to 100ml.
• Sufentanil
Control group (SF group): sufentanil 2ug/kg + flurbiprofen + ondansetron 16mg + 0.9% normal saline diluted to 100ml.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to double-lumen tracheal extraction	Time to double-lumen tracheal extraction	Within two hours after surgery
Secondary	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.	at 2h , 4h, 12h, 48h after surgery
Secondary	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.	at 2 h , 4 h , 12 h ,24 h,48 h postoperatively
Secondary	sufentanil consumption	sufentanil consumption	Within 48 hours after surgery
Secondary	oxycodone consumption	oxycodone consumption	Within 48 hours after surgery
Secondary	analgesic pump compressions	analgesic pump compressions	Within 48 hours after surgery
Secondary	additional analgesic doses	additional analgesic doses	Within 48 hours after surgery
Secondary	incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin	incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin	Within 48 hours after surgery
Secondary	gastrointestinal recovery (exhaust time)	gastrointestinal recovery (exhaust time)	Within 48 hours after surgery
Secondary	laboratory results of C-reactive protein 1 day before and after surgery	laboratory results of C-reactive protein 1 day before and after surgery	Within 48 hours after surgery
Secondary	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	Within 48 hours after surgery