Youhua Xue1, Zhengli Huang1, Bingwei Cheng2, Jie Sun3, Haidong Zhu1, Yuting Tang4, Xiaoyan Wang5. 1. Center of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, Jiangsu, China. 2. Department of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, 210009, China. 3. Department of Anaesthesiology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, China. 4. Nursing Department, Zhongda Hospital, Medical School, Southeast University, Nanjing, 210009, China. 5. Nursing Department, Zhongda Hospital, Medical School, Southeast University, Nanjing, 210009, China. xywangseu@163.com.
Abstract
BACKGROUND: The study will compare the efficacy and safety of nalbuphine hydrochloride injection and morphine hydrochloride injection for perioperative analgesia in tumor ablation and the differences between the two groups regarding duration of surgery, average daily dose, patient satisfaction with analgesia, quality of life, and other indicators. Furthermore, it will evaluate the clinical application of nalbuphine and morphine for perioperative analgesia in ablation surgery and provides important reference and guidance for clinical practice. METHODS: This is a randomized controlled study. Patients who were diagnosed by clinicians and required tumor ablation are enrolled and randomized to the experimental groups. In the test group, nalbuphine 80 mg + 0.9% normal saline (72 ml) is set in the patient-controlled analgesia pump, which is connected 15 min before ablation under electrocardiogram monitoring and surgery is performed immediately. The doses are as follows: initial,: 0.15 ml/kg,; background:, 0.5 ml/h,; compression:, 2 ml,; and lockout time:, 15 min. If the numeric rating scale is ≥ 4 points, the drug is administered by compression. The control group receives similar treatment under similar conditions as the test group except morphine (80 mg) is administered instead of nalbuphine (80 mg). The primary endpoints are the effective rate of analgesia and the incidence of adverse reactions (nausea and vomiting, dizziness, itching, constipation, hypoxemia, and urinary retention); the secondary endpoints are pain intensity, satisfaction with analgesia, duration of surgery, postoperative hospital stay, average daily dose, uninterrupted completion rate of surgery without complaints of pain, quality of life assessment, and vital signs. DISCUSSION: This study, to the best of our knowledge, is the first randomized controlled trial of nalbuphine patient-controlled analgesia in ablation surgery. TRIAL REGISTRATION: U.S. Clinical Trials Network Registration No.: NCT05073744 . Registered on 11 October, 2021.
BACKGROUND: The study will compare the efficacy and safety of nalbuphine hydrochloride injection and morphine hydrochloride injection for perioperative analgesia in tumor ablation and the differences between the two groups regarding duration of surgery, average daily dose, patient satisfaction with analgesia, quality of life, and other indicators. Furthermore, it will evaluate the clinical application of nalbuphine and morphine for perioperative analgesia in ablation surgery and provides important reference and guidance for clinical practice. METHODS: This is a randomized controlled study. Patients who were diagnosed by clinicians and required tumor ablation are enrolled and randomized to the experimental groups. In the test group, nalbuphine 80 mg + 0.9% normal saline (72 ml) is set in the patient-controlled analgesia pump, which is connected 15 min before ablation under electrocardiogram monitoring and surgery is performed immediately. The doses are as follows: initial,: 0.15 ml/kg,; background:, 0.5 ml/h,; compression:, 2 ml,; and lockout time:, 15 min. If the numeric rating scale is ≥ 4 points, the drug is administered by compression. The control group receives similar treatment under similar conditions as the test group except morphine (80 mg) is administered instead of nalbuphine (80 mg). The primary endpoints are the effective rate of analgesia and the incidence of adverse reactions (nausea and vomiting, dizziness, itching, constipation, hypoxemia, and urinary retention); the secondary endpoints are pain intensity, satisfaction with analgesia, duration of surgery, postoperative hospital stay, average daily dose, uninterrupted completion rate of surgery without complaints of pain, quality of life assessment, and vital signs. DISCUSSION: This study, to the best of our knowledge, is the first randomized controlled trial of nalbuphine patient-controlled analgesia in ablation surgery. TRIAL REGISTRATION: U.S. Clinical Trials Network Registration No.: NCT05073744 . Registered on 11 October, 2021.
Authors: Henrik Petrowsky; Ralph Fritsch; Matthias Guckenberger; Michelle L De Oliveira; Philipp Dutkowski; Pierre-Alain Clavien Journal: Nat Rev Gastroenterol Hepatol Date: 2020-07-17 Impact factor: 46.802
Authors: E Van Cutsem; A Cervantes; R Adam; A Sobrero; J H Van Krieken; D Aderka; E Aranda Aguilar; A Bardelli; A Benson; G Bodoky; F Ciardiello; A D'Hoore; E Diaz-Rubio; J-Y Douillard; M Ducreux; A Falcone; A Grothey; T Gruenberger; K Haustermans; V Heinemann; P Hoff; C-H Köhne; R Labianca; P Laurent-Puig; B Ma; T Maughan; K Muro; N Normanno; P Österlund; W J G Oyen; D Papamichael; G Pentheroudakis; P Pfeiffer; T J Price; C Punt; J Ricke; A Roth; R Salazar; W Scheithauer; H J Schmoll; J Tabernero; J Taïeb; S Tejpar; H Wasan; T Yoshino; A Zaanan; D Arnold Journal: Ann Oncol Date: 2016-07-05 Impact factor: 32.976
Authors: F Cardoso; A Costa; E Senkus; M Aapro; F André; C H Barrios; J Bergh; G Bhattacharyya; L Biganzoli; M J Cardoso; L Carey; D Corneliussen-James; G Curigliano; V Dieras; N El Saghir; A Eniu; L Fallowfield; D Fenech; P Francis; K Gelmon; A Gennari; N Harbeck; C Hudis; B Kaufman; I Krop; M Mayer; H Meijer; S Mertz; S Ohno; O Pagani; E Papadopoulos; F Peccatori; F Penault-Llorca; M J Piccart; J Y Pierga; H Rugo; L Shockney; G Sledge; S Swain; C Thomssen; A Tutt; D Vorobiof; B Xu; L Norton; E Winer Journal: Ann Oncol Date: 2017-01-01 Impact factor: 32.976