drugset / Trial / NCT07315022
Enhanced Recovery After Surgery-Based Multimodal Preemptive Analgesia for Perioperative Management in Transarterial Chemoembolization of Intermediate-to-Advanced Hepatocellular Carcinoma
Phase 4
Completed
129 enrolled
First Affiliated Hospital, Sun Yat-Sen University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University · collabJinshazhou Hospital of Guangzhou University of Chinese Medicine · collab
RandomizedSingle-groupOpen-labelTreatment
Summary
To evaluate the effectiveness of the combination of hydrochloride hydromorphone and flurbiprofen ester for post-TACE intravenous patient-controlled intravenous analgesia (PCIA).
Timeline
- Start
- 2024-08-01
- Primary completion
- 2025-08-30
- Completion
- 2025-08-30
Publications
- Results Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
- Results Thompson AR, Vernamonti JP, Rollins P, Speck KE. Implementing Change: Sustaining Enhanced Recovery After Surgery Protocols in Pediatric Surgery Using Iterative Assessments. J Surg Res. 2024 Jun;298:371-378. doi: 10.1016/j.jss.2024.03.039. Epub 2024 Apr 25.
- Results Ribero L, Santia MC, Borchardt K, Zabaneh F, Beck A, Sadhu A, Edwards K, Harrelson M, Pinales-Rodriguez A, Yates EM, Ramirez PT. Surgical site infection prevention bundle in gynecology oncology surgery: a key element in the implementation of an enhanced recovery after surgery (ERAS) program. Int J Gynecol Cancer. 2024 Sep 2;34(9):1445-1453. doi: 10.1136/ijgc-2024-005423.
- Results Zhou J, Sun H, Wang Z, Cong W, Zeng M, Zhou W, Liu L, Wen T, Kuang M, Zhang B, Tao K, Han G, Yan Z, Wang M, Liu R, Guo J, Zeng Z, Liang P, Ren Z, Hou J, Zhang Y, Liu X, Pan H, Bi F, Liang C, Chen M, Yan F, Xu H, Xie X, Ju S, Ji Y, Yun J, Li Z, Bai X, Cai D, Chen W, Chen Y, Chen Y, Cheng W, Cheng S, Dai Z, Dai C, Gao Q, Guo R, Guo W, Guo Y, Hua B, Huang X, Jiang H, Jia W, Li Q, Li T, Li X, Li X, Li Y, Li Y, Liang J, Liang X, Ling C, Liu H, Liu T, Lu S, Lv G, Mao Y, Meng Z, Peng T, Ren W, Shi G, Shi H, Shi M, Song T, Tan G, Wang J, Wang K, Wang L, Wang W, Wang X, Wang Z, Xiang B, Xia J, Xing B, Xu J, Xu J, Yang J, Yang X, Yang Y, Yang Y, Yao X, Yin Z, Yuan Z, Zeng Y, Zeng Y, Zhang B, Zhang L, Zhang S, Zhang T, Zhang Z, Zhao M, Zhao Y, Zheng H, Zhou L, Zhu J, Zhu K, Shi Y, Liu R, Zhang L, Xiao Y, Yang C, Wu Z, Ding Z, Zhu X, Tang Z, Huang X, Han H, Wu H, Chen M, Wang W, Li Q, Cai J, Shen F, Cai X, Qin S, Teng G, Fan J. China Liver Cancer Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2024 Edition). Liver Cancer. 2025 Jul 10;14(6):779-835. doi: 10.1159/000546574. eCollection 2025 Dec.
- Results Liu J, Zhang W, Lu H, Li H, Zhou X, Li J, Han X. Drug-eluting bead trans-arterial chemoembolization combined with microwave ablation therapy vs. microwave ablation alone for early stage hepatocellular carcinoma: a preliminary investigation of clinical value. J Cancer Res Clin Oncol. 2022 Jul;148(7):1781-1788. doi: 10.1007/s00432-021-03760-x. Epub 2021 Aug 17.
- Results Zhu XD, Li KS, Sun HC. Adjuvant therapies after curative treatments for hepatocellular carcinoma: Current status and prospects. Genes Dis. 2020 Feb 29;7(3):359-369. doi: 10.1016/j.gendis.2020.02.002. eCollection 2020 Sep.
- Results Jones DB, Abu-Nuwar MRA, Ku CM, Berk LS, Trainor LS, Jones SB. Less pain and earlier discharge after implementation of a multidisciplinary enhanced recovery after surgery (ERAS) protocol for laparoscopic sleeve gastrectomy. Surg Endosc. 2020 Dec;34(12):5574-5582. doi: 10.1007/s00464-019-07358-w. Epub 2020 Jan 14.
- Results Interventional perioperative committee of Chinese College of Interventionalists, clinical practice guideline committee of Chinese college of interventionalists. Expert consensus on perioperative pain management for interventional treatment of hepatic malignancies (2022). J Interv Radiol. 2022;31(10):943-948.
- Results Meyer T, Fox R, Ma YT, Ross PJ, James MW, Sturgess R, Stubbs C, Stocken DD, Wall L, Watkinson A, Hacking N, Evans TRJ, Collins P, Hubner RA, Cunningham D, Primrose JN, Johnson PJ, Palmer DH. Sorafenib in combination with transarterial chemoembolisation in patients with unresectable hepatocellular carcinoma (TACE 2): a randomised placebo-controlled, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2017 Aug;2(8):565-575. doi: 10.1016/S2468-1253(17)30156-5. Epub 2017 Jun 23.
- Results Golfieri R, Giampalma E, Renzulli M, Cioni R, Bargellini I, Bartolozzi C, Breatta AD, Gandini G, Nani R, Gasparini D, Cucchetti A, Bolondi L, Trevisani F; PRECISION ITALIA STUDY GROUP. Randomised controlled trial of doxorubicin-eluting beads vs conventional chemoembolisation for hepatocellular carcinoma. Br J Cancer. 2014 Jul 15;111(2):255-64. doi: 10.1038/bjc.2014.199. Epub 2014 Jun 17.
- Results Benzakoun J, Ronot M, Lagadec M, Allaham W, Garcia Alba C, Sibert A, Vilgrain V. Risks factors for severe pain after selective liver transarterial chemoembolization. Liver Int. 2017 Apr;37(4):583-591. doi: 10.1111/liv.13235. Epub 2016 Sep 2.
- Results Zhou B, Wang J, Yan Z, Shi P, Kan Z. Liver cancer: effects, safety, and cost-effectiveness of controlled-release oxycodone for pain control after TACE. Radiology. 2012 Mar;262(3):1014-21. doi: 10.1148/radiol.11110552.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydromorphone | Other / unclassified | 6 mg | — |
| Subject | flurbiprofen axetil | Other / unclassified | 50 mg | Intravenous |
| Comparator | Tramadol | Other / unclassified | 100 mg | Intramuscular |
Indications
No indication recorded.