Nalbuphine Versus Morphine for Perioperative Tumor Ablation

Southeast University

Status and phase: Enrolling; Phase 4

Conditions: Ablation; Nalbuphine Allergy; Safety

Treatments: Drug: Nalbuphine; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT05073744

NPRCT001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 316 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients requiring tumor ablation;
• Voluntarily participate and sign the informed consent.

Exclusion criteria

• Allergic to contrast agent, test drug or other ingredients;
• With a history of substance abuse, chronic pain and mental illness;
• Use of any monamine oxidase inhibitor within 14 days prior to randomization;
• Pregnant or breastfeeding;
• Cannot tolerate ablation due to other reasons;
• Cannot express their wishes correctly;
• Poor compliance, unable to complete the trial;
• Have participated in other drug trials within 30 days prior to enrollment;
• Judged by the researcher to be unsuitable.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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316 participants in 2 patient groups

Tumor ablation using nalbuphine for pain control and anaesthesia

Experimental group

Description:

Nalbuphine hydrochloride injection (80mg) plus 0.9% saline are combined into 80 ml self-controlled analgesic pump, which will be run 25minutes before ablation under Electrocardiogram monitoring. Single pressure administration if numerical rating scale≥4 points.

Treatment:

Drug: Nalbuphine

Tumor ablation using morphine for pain control and anaesthesia

Active Comparator group

Description:

Morphine hydrochloride injection (80mg) plus 0.9% saline are combined into 80 ml self-controlled analgesic pump, which will be run 25minutes before ablation under Electrocardiogram monitoring. Single pressure administration if numerical rating scale≥4 points.

Treatment:

Drug: Morphine