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Open Access 01-12-2022 | Analgesics in Dentistry | Study protocol

Analgesic efficacy and safety of nalbuphine versus morphine for perioperative tumor ablation: a randomized, controlled, multicenter trial

Authors: Youhua Xue, Zhengli Huang, Bingwei Cheng, Jie Sun, Haidong Zhu, Yuting Tang, Xiaoyan Wang

Published in: Trials | Issue 1/2022

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.

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Chen W, Zheng R, Baade PD, et al. Cancer statistics in China, 2015. CA Cancer J Clin. 2016. 2017;66:115–32. https://doi.org/10.3322/caac.21338 China Science and Technology Press.CrossRef

World Health Organization (WHO). World cancer Report 2020. 2020. https://www.iarc.fr/cards_page/world-cancer-report/CrossRef

Zhang S, Sun K, Zheng R, et al. Cancer incidence and mortality in China, 2015. J Natl Cancer Center. 2020. https://doi.org/10.1016/j.jncc.2020.12.001.

Feng RM, Zong YN, Cao SM, Xu RH. Current cancer situation in China: good or bad news from the 2018 Global Cancer Statistics? Cancer Commun (Lond). 2019;39:22. https://doi.org/10.1186/s40880-019-0368-6.CrossRef

Cao B, Bray F, Ilbawi A, et al. Effect on longevity of one-third reduction in premature mortality from non-communicable diseases by 2030: a global analysis of the Sustainable Development Goal health target. Lancet Glob Health. 2018;6:e1288–96. https://doi.org/10.1016/S2214-109X(18)30411-X.CrossRefPubMed

Petrowsky H, Fritsch R, Guckenberger M, De Oliveira ML, Dutkowski P, Clavien PA. Modern therapeutic approaches for the treatment of malignant liver tumours. Nat Rev Gastroenterol Hepatol. 2020;17:755–72. https://doi.org/10.1038/s41575-020-0314-8.CrossRefPubMed

Grasso A, Watkinson AF, Tibballs JM, Burroughs AK. Radiofrequency ablation in the treatment of hepatocellular carcinoma--a clinical viewpoint. J Hepatol. 2000;33:667–72. https://doi.org/10.1034/j.1600-0641.2000.033004667.x.CrossRefPubMed

Van Cutsem E, Cervantes A, Adam R, Sobrero A, Van Krieken JH, Aderka D, et al. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol. 2016;27:1386–422. https://doi.org/10.1093/annonc/mdw235.CrossRefPubMed

Bersanelli M, Brunelli M, Gnetti L, Maestroni U, Buti S. Pazopanib as a possible option for the treatment of metastatic non-clear cell renal carcinoma patients: a systematic review. Ther Adv Med Oncol. 2020;12:1758835920915303. https://doi.org/10.1177/1758835920915303.CrossRefPubMedPubMedCentral

10.

Pacini F, Castagna MG, Brilli L, et al. Thyroid cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up;29 Suppl 4:iv257-iv258. Ann Oncol. 2012;23(Suppl 7):vii110–9. https://doi.org/10.1093/annonc/mds230.CrossRefPubMed

11.

Horwich A, Parker C, de Reijke T, Kataja V. ESMO Guidelines Working Group. Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24(Suppl 6):vi106–14. https://doi.org/10.1093/annonc/mdt208.CrossRefPubMed

12.

Pentheroudakis G, Guidelines ESMO, Committee. Recent eUpdates to the ESMO Clinical Practice Guidelines on hepatocellular carcinoma, cancer of the pancreas, soft tissue and visceral sarcomas, cancer of the prostate and gastric cancer. Ann Oncol. 2019;30:1395–7. https://doi.org/10.1093/annonc/mdz180 PMID: 31168599.CrossRefPubMed

13.

Cardoso F, Costa A, Senkus E, et al. 3rd ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 3) (12):3111. Ann Oncol. 2017;28:16–33. https://doi.org/10.1093/annonc/mdw544.CrossRefPubMed

14.

Ying W, Weijun F. Development history, current situation and prospect of tumor ablation therapy. China Res Hosp. 2021;8:22–6.

15.

Cashman JN, Ng L. The management of peri- and postprocedural pain in interventional radiology: a narrative review. Pain Manag. 2017;7:523–35. https://doi.org/10.2217/pmt-2017-0024.CrossRefPubMed

16.

Lee S, Rhim H, Kim YS, Choi D, Lee WJ, Lim HK, et al. Percutaneous radiofrequency ablation of hepatocellular carcinomas: factors related to intraprocedural and postprocedural pain. AJR Am J Roentgenol. 2009;192:1064–70. https://doi.org/10.2214/AJR.08.1350.CrossRefPubMed

17.

Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, et al. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018;35:6–24. https://doi.org/10.1097/EJA.0000000000000683.CrossRefPubMed

18.

Practice guidelines for moderate procedural sedation and analgesia. A report by the American Society of Anesthesiologists Task Force on Moderate Procedural Sedation and Analgesia, the American Association of Oral and Maxillofacial Surgeons, American College of Radiology, American Dental Association, American Society of Dentist Anesthesiologists, and Society of Interventional Radiology. Anesthesiology. 2018;2018(128):437–79. https://doi.org/10.1097/ALN.0000000000002043.CrossRef

19.

Kaye AD, Jones MR, Viswanath O, Candido KD, Boswell MV, Soin A, et al. ASIPP guidelines for sedation and fasting status of patients undergoing interventional pain management procedures. Pain Physician. 2019;22:201–7.PubMed

20.

Romagnoli S, Fanelli F, Barbani F, Uberoi R, Esteban E, Lee MJ, et al. CIRSE standards of practice on analgesia and sedation for interventional radiology in adults. Cardiovasc Intervent Radiol. 2020;43:1251–60. https://doi.org/10.1007/s00270-020-02536-z.CrossRefPubMed

21.

Caraceni A, Hanks G, Kaasa S, Bennett MI, Brunelli C, Cherny N, et al. Use of opioid analgesics in the treatment of cancer pain: evidence-based recommendations from the EAPC. Lancet Oncol. 2012;13:e58–68. https://doi.org/10.1016/S1470-2045(12)70040-2.CrossRefPubMed

22.

Shanthanna H, Ladha KS, Kehlet H, Joshi GP. Perioperative opioid administration. Anesthesiology. 2021;134:645–59. https://doi.org/10.1097/ALN.0000000000003572.CrossRefPubMed

23.

Christrup LL. Morphine metabolites. Acta Anaesthesiol Scand. 1997;41:116–22. https://doi.org/10.1111/j.1399-6576.1997.tb04625.x.CrossRefPubMed

24.

Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, et al. Opioid complications and side effects. Pain Physician. 2008;11(2):S105–20.CrossRef

25.

Verberkt CA, van den Beuken-van Everdingen MHJ, Schols JMGA, Datla S, Dirksen CD, Johnson MJ, et al. Respiratory adverse effects of opioids for breathlessness: a systematic review and meta-analysis. Eur Respir J. 2017;50:29167300. https://doi.org/10.1183/13993003.01153-2017.CrossRef

26.

Kiyatkin EA. Respiratory depression and brain hypoxia induced by opioid drugs: morphine, oxycodone, heroin, and fentanyl. Neuropharmacology. 2019;151:219–26. https://doi.org/10.1016/j.neuropharm.2019.02.008.CrossRefPubMedPubMedCentral

27.

Bennett MW, Shah MV, Bembridge JL. A comparison of the effect on gastric emptying of alfentanil or morphine given during anaesthesia for minor surgery. Anaesthesia. 1994;49:155–6. https://doi.org/10.1111/j.1365-2044.1994.tb03376.x.CrossRefPubMed

28.

Duthie DJ, Nimmo WS. Adverse effects of opioid analgesic drugs. Br J Anaesth. 1987;59:61–77. https://doi.org/10.1093/bja/59.1.61.CrossRefPubMed

29.

Zeng Z, Lu J, Shu C, Chen Y, Guo T, Wu Q, et al. A comparison of nalbuphine with morphine for analgesic effects and safety: meta-analysis of randomized controlled trials. Sci Rep. 2015;5:10927. https://doi.org/10.1038/srep10927.CrossRefPubMedPubMedCentral

30.

Momeni M, Crucitti M, De Kock M. Patient-controlled analgesia in the management of postoperative pain. Drugs. 2006;66:2321–37. https://doi.org/10.2165/00003495-200666180-00005.CrossRefPubMed

31.

Zacny JP, Conley K, Marks S. Comparing the subjective, psychomotor and physiological effects of intravenous nalbuphine and morphine in healthy volunteers. J Pharmacol Exp Ther. 1997;280:1159–69.PubMed

32.

Stene JK, Stofberg L, MacDonald G, Myers RA, Ramzy A, Burns B. Nalbuphine analgesia in the prehospital setting. Am J Emerg Med. 1988;6:634–9. https://doi.org/10.1016/0735-6757(88)90109-x.CrossRefPubMed

33.

Chambers JA, Guly HR. Prehospital intravenous nalbuphine administered by paramedics. Resuscitation. 1994;27:153–8. https://doi.org/10.1016/0300-9572(94)90008-6.CrossRefPubMed

34.

Moustafa AA, Baaror AS, Abdelazim IA. Comparative study between nalbuphine and ondansetron in prevention of intrathecal morphine-induced pruritus in women undergoing cesarean section. Anesth Essays Res. 2016;10:238–44. https://doi.org/10.4103/0259-1162.167839.CrossRefPubMedPubMedCentral

35.

Weibel S, Jelting Y, Afshari A, Pace NL, Eberhart LH, Jokinen J, et al. Patient-controlled analgesia with remifentanil versus alternative parenteral methods for pain management in labour. Cochrane Database Syst Rev. 2017;4:CD011989. https://doi.org/10.1002/14651858.CD011989.pub2.CrossRefPubMed

36.

Peng Z, Zhang Y, Guo J, Guo X, Feng Z. Patient-controlled intravenous analgesia for advanced cancer patients with pain: A retrospective series study. Pain Res Manag. 2018;2018:7323581. https://doi.org/10.1155/2018/7323581.CrossRefPubMedPubMedCentral

37.

Lin LF, Hung CJ. Patient value of patient-controlled analgesia. J Chin Med Assoc. 2020;83:512. https://doi.org/10.1097/JCMA.0000000000000305.CrossRefPubMed

38.

Mann C, Ouro-Bang’na F, Eledjam JJ. Patient-controlled analgesia. Curr Drug Targets. 2005;6:815–9. https://doi.org/10.2174/138945005774574524.CrossRefPubMed

39.

Deflandre E, Jaucot J. Patient-controlled analgesia: past, present and future. Minerva Anestesiol. 2016;82:811–3.PubMed

Title: Analgesic efficacy and safety of nalbuphine versus morphine for perioperative tumor ablation: a randomized, controlled, multicenter trial
Authors: Youhua Xue
Zhengli Huang
Bingwei Cheng
Jie Sun
Haidong Zhu
Yuting Tang
Xiaoyan Wang
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Analgesics in Dentistry
Morphine
Nalbuphine
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06825-5

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Analgesic efficacy and safety of nalbuphine versus morphine for perioperative tumor ablation: a randomized, controlled, multicenter trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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