NCT05073744

Nalbuphine Versus Morphine for Perioperative Tumor Ablation

Analgesic Efficacy and Safety of Nalbuphine Versus Morphine for Perioperative Tumor Ablation: a Randomized, Control, Multicentre Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 316 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This randomized, positive control, multicentre trial is designed to compare the analgesic efficacy and safety of nalbuphine hydrochloride injection and morphine hydrochloride injection for perioperative tumor ablation.

Detailed description

Sedation and analgesia use in tumor ablation is a necessary part of the procedure. However, the optimal medicine for sedation and analgesia for tumor ablation remains controversial. Currently, morphine is a traditional opioid used for pain control and anaesthesia. As no publications have compared the anaesthetic and analgesic effects between nalbuphine and morphine during tumor ablation, this trial aims to compare the analgesic efficacy and safety of nalbuphine and morphine for perioperative tumor ablation. In addition, other endpoints in term of perioperative analgesia indexes, such as ablation time, daily dose, analgesia satisfaction, quality of life, and safety, etc. will be compared.

Conditions

• Nalbuphine Allergy
• Ablation
• Safety

Interventions

Type	Name	Description
DRUG	Nalbuphine	Nalbuphine hydrochloride injection or morphine hydrochloride injection is used for perioperative tumor ablation
DRUG	Morphine	Morphine hydrochloride injection is used for perioperative tumor ablation

Timeline

• Start date: 2021-09-05
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2021-10-11
• Last updated: 2022-12-29

Locations

20 sites across 1 country: China