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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.

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.

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

Morphine hydrochloride injection is used for perioperative tumor ablation

Xiao-Yan Wang

Hai-Dong Zhu, MD

Gao-Jun Teng, MD

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.

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.

Nalbuphine Versus Morphine for Perioperative Tumor Ablation

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

Other researchers can contact the PI for data.

Adverse reactions related with nalbuphine or morphine according to "Common Terminology Criteria for Adverse Events" by "National Cancer Institute" (NCI-CTCAE, version5.0)

No. effective cases / No.Total cases \* 100%. The numerical rating scale score at the evaluation time point (at rest) ≤3 is considered as effective analgesia.

Pain assessment using the numerical rating scale (NRS), which is composed of 11 numbers spaced from 0 to 10, with 0 representing "no pain" and 10 representing "most intense pain". Patients chose 1 number to represent their pain intensity.

Scored using visual analogue scale, a 10 cm long scale, marked with 10 markers, both ends of 0 point and 10 points respectively. Participant and medical care personnel mark the corresponding position on a ruler that represents their satisfaction. A score of 0 represents extremely dissatisfied and a score of 10 represents very satisfied.

Days from the time of ablation to Discharge time

No. ablation without complaining of pain cases / No.Total cases \* 100%

Total dose of nalbuphine or morphine / Total days of analgesia

Assessed by telephone, using the standard of Quality of Life Question-Core by the European O-Rganization for Reasearch and Treatment of Cancer (EORTC QLQ-C30 scale,Version 3.0). The evaluation of quality of life from a multi-dimensional perspective can better reflect the connotation of quality of life, which has been applied to measure QOL of cancer patients in many countries and regions. A total of 30 questions will be replied with different points. Higher score represents lower quality of life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Nalbuphine Versus Morphine for Perioperative Tumor Ablation	NCT05073744	Nalbuphine Alle... Ablation Safety	Nalbuphine Morphine	18 Years - 80 Years	Zhongda Hospital
Nalbuphine Versus Morphine for Perioperative Tumor Ablation	NCT05073744	Nalbuphine Alle... Ablation Safety	Nalbuphine Morphine	18 Years - 80 Years	Zhongda Hospital

Spots Global Cancer Trial Database for nalbuphine

Every month we try and update this database with for nalbuphine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nalbuphine

Every month we try and update this database with for nalbuphine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nalbuphine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.