Ablation, Nalbuphine Allergy, Safety
Conditions
Brief 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.
Interventions
DRUGNalbuphine
Nalbuphine hydrochloride injection or morphine hydrochloride injection is used for perioperative tumor ablation
DRUGMorphine
Morphine hydrochloride injection is used for perioperative tumor ablation
Sponsors
Zhongda Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic efficiency | From the begin to 48 hours after procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | From the begin to 48 hours after procedure | 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. |
| Analgesia satisfaction | Up to 4 hours | 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. |
| Duration of ablation | Up to 4 hours | Duration of the whole procedure |
| Rate of continuous ablation without complaining of pain | Up to 4 hours | No. ablation without complaining of pain cases / No.Total cases \* 100% |
| Average daily dosage | From nalbuphine/morphine use to 48 hours after procedure | Total dose of nalbuphine or morphine / Total days of analgesia |
| Health-related quality of life | 7 days after procedure | 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. |
| Postoperative hospital stay | Up to 10 days | Days from the time of ablation to Discharge time |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety end point | From nalbuphine/morphine use to 48 hours after procedure | Adverse reactions related with nalbuphine or morphine according to Common Terminology Criteria for Adverse Events by National Cancer Institute (NCI-CTCAE, version5.0) |
Countries
China
Contacts
Primary ContactXiao-Yan Wang
Backup ContactHai-Dong Zhu, MD
Outcome results
None listed