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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
316
Nalbuphine hydrochloride injection or morphine hydrochloride injection is used for perioperative tumor ablation
Morphine hydrochloride injection is used for perioperative tumor ablation
Anhui Province Cancer Hospital
Hefei, Anhui, China
Analgesic efficiency
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.
Time frame: From the begin to 48 hours after procedure
Pain intensity
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.
Time frame: From the begin to 48 hours after procedure
Analgesia satisfaction
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.
Time frame: Up to 4 hours
Duration of ablation
Duration of the whole procedure
Time frame: Up to 4 hours
Postoperative hospital stay
Days from the time of ablation to Discharge time
Time frame: Up to 10 days
Rate of continuous ablation without complaining of pain
No. ablation without complaining of pain cases / No.Total cases \* 100%
Time frame: Up to 4 hours
Average daily dosage
Total dose of nalbuphine or morphine / Total days of analgesia
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The Second Hospital of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGThe First Hospital of Lanzhou University
Lanzhou, Gansu, China
NOT_YET_RECRUITINGGuangxi Medical University Affiliated Tumor Hospita
Nanning, Guangxi, China
NOT_YET_RECRUITINGThe People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
NOT_YET_RECRUITINGThe Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
NOT_YET_RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
NOT_YET_RECRUITINGJingmen NO.2People's Hospital
Jingmen, Hubei, China
NOT_YET_RECRUITING...and 10 more locations
Time frame: From nalbuphine/morphine use to 48 hours after procedure
Health-related quality of life
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.
Time frame: 7 days after procedure