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

Sponsor

Qianfoshan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05742256

Collaborator

(none)

159

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oxycodone	Drug: Oxycodone 1mg/kg Drug: Oxycodone 1.5mg/kg Drug: Sufentanil	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

159 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test group 1(OCA group)	Drug: Oxycodone 1mg/kg Test group 1 (OCA group):oxycodone 1mg/kg + flurbiprofen 50mg + ondansetron 16mg + 0.9% normal saline diluted to 100ml Other Names: Oxycodone
Experimental: Test group 2(OCB group)	Drug: Oxycodone 1.5mg/kg Test group 2 (OCB group): oxycodone 1.5mg/kg + flurbiprofen 50mg + ondansetron 16mg + 0.9% normal saline diluted to 100ml.
Active Comparator: Control group(SF group)	Drug: Sufentanil Control group (SF group): sufentanil 2ug/kg + flurbiprofen + ondansetron 16mg + 0.9% normal saline diluted to 100ml.

Arm

Intervention/Treatment

Experimental: Test group 1(OCA group)

Drug: Oxycodone 1mg/kg

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

Other Names:

Oxycodone

Experimental: Test group 2(OCB group)

Drug: Oxycodone 1.5mg/kg

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

Active Comparator: Control group(SF group)

Drug: Sufentanil

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

Outcome Measures

Primary Outcome Measures

The main indicators were NRS scores at rest and cough at 24 h postoperatively. [at 24h after surgery]
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.

Secondary Outcome Measures

Time to double-lumen tracheal extraction [Within two hours after surgery]
Time to double-lumen tracheal extraction
NRS score at rest and cough [at 2h , 4h, 12h, 48h after surgery]
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.
sedation score (Ramsay sedation score) [at 2 h , 4 h , 12 h ,24 h,48 h postoperatively]
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.
sufentanil consumption [Within 48 hours after surgery]
sufentanil consumption
oxycodone consumption [Within 48 hours after surgery]
oxycodone consumption
analgesic pump compressions [Within 48 hours after surgery]
analgesic pump compressions
additional analgesic doses [Within 48 hours after surgery]
additional analgesic doses
incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin [Within 48 hours after surgery]
incidence of adverse reactions: nausea, vomiting, respiratory depression, dizziness, itchin
gastrointestinal recovery (exhaust time) [Within 48 hours after surgery]
gastrointestinal recovery (exhaust time)
laboratory results of C-reactive protein 1 day before and after surgery [Within 48 hours after surgery]
laboratory results of C-reactive protein 1 day before and after surgery
laboratory results of interleukin-6 laboratory test 1 day before and after surgery [Within 48 hours after surgery]
laboratory results of interleukin-6 laboratory test 1 day before and after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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 -