Nalbuphine Versus Morphine for Perioperative Tumor Ablation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-05

Study Completion Date

2023-08-31

Brief Summary

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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

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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

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Nalbuphine Allergy Ablation Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Tumor ablation using nalbuphine for pain control and anaesthesia

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.

Group Type EXPERIMENTAL

Nalbuphine

Intervention Type DRUG

Nalbuphine hydrochloride injection or morphine hydrochloride injection is used for perioperative tumor ablation

Tumor ablation using morphine for pain control and anaesthesia

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.

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Morphine hydrochloride injection is used for perioperative tumor ablation

Interventions

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Nalbuphine

Nalbuphine hydrochloride injection or morphine hydrochloride injection is used for perioperative tumor ablation

Intervention Type DRUG

Morphine

Morphine hydrochloride injection is used for perioperative tumor ablation

Intervention Type DRUG

Other Intervention Names

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Tumor ablation using nalbuphine Tumor ablation using morphine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Gao-jun Teng

Chair, Center of IR and vascular surgery, Department of radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gao-Jun Teng, MD

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

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