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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor ablation using nalbuphine for pain control and anaesthesia | Experimental | 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. |
|
| Tumor ablation using morphine for pain control and anaesthesia | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalbuphine | Drug | Nalbuphine hydrochloride injection or morphine hydrochloride injection is used for perioperative tumor ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the begin to 48 hours after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the begin to 48 hours after procedure |
| Analgesia satisfaction |
| Measure | Description | Time Frame |
|---|---|---|
| Safety end point | Adverse reactions related with nalbuphine or morphine according to "Common Terminology Criteria for Adverse Events" by "National Cancer Institute" (NCI-CTCAE, version5.0) | From nalbuphine/morphine use to 48 hours after procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao-Yan Wang | Contact | 86 13851821464 | xywangseu@163.com | |
| Hai-Dong Zhu, MD | Contact | 86-25-83262224 | zhuhaidong9509@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Gao-Jun Teng, MD | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Province Cancer Hospital | Not yet recruiting | Hefei | Anhui | China | ||
| The Second Hospital of Anhui Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16650261 | Background | Laurent G, Bertaux G, Martel A, Fraison M, Fromentin S, Gonzalez S, Pierre FS, Wolf JE. A randomized clinical trial of continuous flow nitrous oxide and nalbuphine infusion for sedation of patients during radiofrequency atrial flutter ablation. Pacing Clin Electrophysiol. 2006 Apr;29(4):351-7. doi: 10.1111/j.1540-8159.2006.00352.x. | |
| 33364949 |
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Other researchers can contact the PI for data.
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| ID | Term |
|---|---|
| D009266 | Nalbuphine |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
| Morphine | Drug | Morphine hydrochloride injection is used for perioperative tumor ablation |
|
|
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. |
| Up to 4 hours |
| Duration of ablation | Duration of the whole procedure | Up to 4 hours |
| Postoperative hospital stay | Days from the time of ablation to Discharge time | Up to 10 days |
| Rate of continuous ablation without complaining of pain | No. ablation without complaining of pain cases / No.Total cases * 100% | Up to 4 hours |
| Average daily dosage | Total dose of nalbuphine or morphine / Total days of analgesia | 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. | 7 days after procedure |
| Not yet recruiting |
| Hefei |
| Anhui |
| China |
| The First Hospital of Lanzhou University | Not yet recruiting | Lanzhou | Gansu | China |
| Guangxi Medical University Affiliated Tumor Hospita | Not yet recruiting | Nanning | Guangxi | China |
| The People's Hospital of Guangxi Zhuang Autonomous Region | Not yet recruiting | Nanning | Guangxi | China |
| The Affiliated Cancer Hospital of Guizhou Medical University | Not yet recruiting | Guiyang | Guizhou | China |
| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | China |
| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | China |
| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | China |
| Jingmen NO.2People's Hospital | Not yet recruiting | Jingmen | Hubei | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | China |
| Yichang Central People's Hospital | Not yet recruiting | Yichang | Hubei | China |
| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | China |
| Zhongda Hospital Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
| The Affiliated Hospital of Xuzhou Medical University | Not yet recruiting | Xuzhou | Jiangsu | China |
| The First Bethune Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | China |
| Shengjing Hospital of China Medical University | Not yet recruiting | Shengyang | Liaoning | China |
| Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | China |
| Shanghai Tenth People's Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
| Lishui Municipal Central Hospital | Not yet recruiting | Lishui | Zhejiang | China |
| Sun S, Guo Y, Wang T, Huang S. Analgesic Effect Comparison Between Nalbuphine and Sufentanil for Patient-Controlled Intravenous Analgesia After Cesarean Section. Front Pharmacol. 2020 Nov 16;11:574493. doi: 10.3389/fphar.2020.574493. eCollection 2020. |
| 33887111 | Background | Yu P, Zhang J, Wang J. Nalbuphine for spinal anesthesia: A systematic review and meta-analysis. Pain Pract. 2022 Jan;22(1):91-106. doi: 10.1111/papr.13021. Epub 2021 Jun 2. |
| 36273202 | Derived | Xue Y, Huang Z, Cheng B, Sun J, Zhu H, Tang Y, Wang X. Analgesic efficacy and safety of nalbuphine versus morphine for perioperative tumor ablation: a randomized, controlled, multicenter trial. Trials. 2022 Oct 22;23(1):887. doi: 10.1186/s13063-022-06825-5. |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009022 | Morphine Derivatives |