Safety Clinical Trial
Official title:
Analgesic Efficacy and Safety of Nalbuphine Versus Morphine for Perioperative Tumor Ablation: a Randomized, Control, Multicentre Trial
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.
Status | Recruiting |
Enrollment | 316 |
Est. completion date | August 31, 2023 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Bethune Hospital of Jilin University | Changchun | Jilin |
China | The Second Xiangya Hospital of Central South University | Changsha | Hunan |
China | The Affiliated Cancer Hospital of Guizhou Medical University | Guiyang | Guizhou |
China | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang |
China | Anhui Province Cancer Hospital | Hefei | Anhui |
China | The Second Hospital of Anhui Medical University | Hefei | Anhui |
China | Jingmen NO.2People's Hospital | Jingmen | Hubei |
China | The First Hospital of Lanzhou University | Lanzhou | Gansu |
China | Lishui Municipal Central Hospital | Lishui | Zhejiang |
China | Zhongda Hospital Southeast University | Nanjing | Jiangsu |
China | Guangxi Medical University Affiliated Tumor Hospita | Nanning | Guangxi |
China | The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi |
China | Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai |
China | Shanghai Tenth People's Hospital | Shanghai | Shanghai |
China | Shengjing Hospital of China Medical University | Shengyang | Liaoning |
China | Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei |
China | The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu |
China | Yichang Central People's Hospital | Yichang | Hubei |
China | Henan Provincial People's Hospital | Zhengzhou | Henan |
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Zhongda Hospital |
China,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | 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. | Up to 4 hours | |
Secondary | Duration of ablation | Duration of the whole procedure | Up to 4 hours | |
Secondary | Postoperative hospital stay | Days from the time of ablation to Discharge time | Up to 10 days | |
Secondary | Rate of continuous ablation without complaining of pain | No. ablation without complaining of pain cases / No.Total cases * 100% | Up to 4 hours | |
Secondary | Average daily dosage | Total dose of nalbuphine or morphine / Total days of analgesia | From nalbuphine/morphine use to 48 hours after procedure | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03969641 -
Safety of RIV4 Versus IIV4 in Pregnant Women
|
Phase 4 | |
Completed |
NCT05592951 -
Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers
|
N/A | |
Completed |
NCT04693429 -
Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+
|
Phase 1 | |
Completed |
NCT01636024 -
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594
|
Phase 1 | |
Completed |
NCT01415102 -
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
|
Phase 1 | |
Completed |
NCT01243502 -
A Study to Assess the Pharmacokinetics, Safety and Tolerability of CT327 in Healthy Male Volunteers
|
Phase 1 | |
Completed |
NCT06072170 -
Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience
|
Phase 1 | |
Completed |
NCT05076253 -
Efficacy of Ivermectin in COVID-19
|
Phase 1/Phase 2 | |
Recruiting |
NCT06060379 -
Giochiamo 626 - Gaming for Health and Safety in Workplaces
|
N/A | |
Recruiting |
NCT05298800 -
Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23
|
Phase 4 | |
Completed |
NCT05188638 -
Safety of Ascending Single and Multiple Doses of Nebulised SoftOx Inhalation Solution in Healthy Subjects
|
Phase 1 | |
Completed |
NCT05145621 -
Oral Bio-equivalence Study
|
Phase 1 | |
Recruiting |
NCT05580159 -
New Generation mRNA Booster Vaccine Against Emerging VOCs
|
Phase 3 | |
Not yet recruiting |
NCT04596956 -
Safety and Efficacy of Sodium Bicarbonate Ringer Injection
|
Phase 4 | |
Completed |
NCT03033329 -
Single Dose Escalation and Multiple Dose Escalation Trial of an Intravenous Formulation of MRX-4
|
Phase 1 | |
Terminated |
NCT01929811 -
NeoMET Study in Neoadjuvant Treatment of Breast Cancer
|
Phase 2 | |
Completed |
NCT01193335 -
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
|
Phase 4 | |
Completed |
NCT03300466 -
A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
|
N/A | |
Active, not recruiting |
NCT05686161 -
mRNA Booster Vaccine(SW-BIC-213) Compared With Pfizer andSinopharm Against Emerging VOCs
|
Phase 3 | |
Recruiting |
NCT06046053 -
MATRIX-002: Trial to Assess Acceptability and Safety of Two Placebo Vaginal Films
|
Early Phase 1 |