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Enhanced Recovery After SurgeryPhase 4NCT07315022

Enhanced Recovery After Surgery-Based Multimodal Preemptive Analgesia for Perioperative Management in Transarterial Chemoembolization of Intermediate-to-Advanced Hepatocellular Carcinoma

A Phase 4 study testing hydrochloride hydromorphone + flurbiprofen axetil and conventional analgesia in people with Enhanced Recovery After Surgery and Multimodal Analgesia, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the effectiveness of the combination of hydrochloride hydromorphone and flurbiprofen ester for post-TACE intravenous patient-controlled intravenous analgesia (PCIA). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
hydrochloride hydromorphone + flurbiprofen axetil and conventional analgesia
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
1 siteChina
Study dates
1 Aug 2024to 30 Aug 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically or clinically diagnosed with hepatocellular carcinoma according to the "Guidelines for Diagnosis and Treatment of Primary Liver Cancer" issued by the National Health Commission of China in 2024;
  • staged as China Liver Cancer Stage II-III1 or 2022 Barcelona Clinic Liver Cancer stage B-C14;
  • liver function classified as Child-Pugh grade A or B;
  • ECOG PS score 0-215;
  • meeting the following hematological criteria: white blood cell count ≥3×10⁹/L, platelet count ≥50×10⁹/L, hemoglobin ≥80 g/L, serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤twice the upper limit of normal (ULN), serum creatinine ≤1.5×ULN, INR <1.5 or prothrombin time <ULN + 4 s, albumin (ALB) ≥30 g/L, total bilirubin <34 mmol/L.

Who cannot join

  • History of iodine contrast allergy;
  • severe psychological or psychiatric disorders;
  • history of long-term analgesic medication use;
  • severe cardiopulmonary disease;
  • severe uncontrolled infection;
  • incomplete medical records.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Enhanced Recovery After Surgery-Based Multimodal Preemptive Analgesia for Perioperative Management in Transarterial Chemoembolization of Intermediate-to-Advanced Hepatocellular Carcinoma: a Multicenter Retrospective Cohort Study

To evaluate the effectiveness of the combination of hydrochloride hydromorphone and flurbiprofen ester for post-TACE intravenous patient-controlled intravenous analgesia (PCIA).

Read the detailed description

This multicenter retrospective study analyzed clinical data from 129 patients with intermediate or advanced HCC who underwent TACE at three centers. Patients were divided into perioperative analgesia protocol groups: Group A (n=85) received patient-controlled intravenous analgesia-based multimodal preemptive analgesia (hydromorphone hydrochloride 6 mg, flurbiprofen axetil 50 mg) with background infusion. Group B (n=44) received conventional on-demand analgesia (intraoperative intravenous flurbiprofen axetil 50 mg, intramuscular tramadol 100 mg as needed for pain). Outcome measures included numerical rating pain scale scores, perioperative adverse events, inflammatory markers, hepatic function indicators, analgesia satisfaction, and cost-effectiveness.

Being tested
hydrochloride hydromorphone + flurbiprofen axetil, conventional analgesia
Keywords
Enhanced Recovery After Surgery, Hepatocellular Carcinoma, Transarterial Chemoembolization, Multimodal Analgesia, Real-World Study, Hydromorphone, Flurbiprofen axetil
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hydrochloride hydromorphone + flurbiprofen axetilDrug

    Group A received hydromorphone hydrochloride combined with flurbiprofen axetil via PCIA. The pump was initiated 15 min before surgery, with settings of background infusion 2 ml/h, bolus dose 2 ml, and lockout interval 15 min.

  • conventional analgesiaDrug

    When the NRS score was ≥4, flurbiprofen axetil 50 mg was administered intravenously, with intramuscular tramadol 100 mg added if analgesia was inadequate.

Study groups in NCT07315022
Study groupRoleWhat they receive
A:hydromorphone + flurbiprofen axetilExperimentalGroup A received hydromorphone hydrochloride combined with flurbiprofen axetil via PCIA. Hydromorphone hydrochloride 6 mg (2 mL:2 mg, Hubei Yichang Humanwell Pharmaceutical) + flurbiprofen axetil 50 mg (5 mL:50 mg, Beijing Tide Pharmaceutical) were diluted with normal saline to 100 ml and loaded into a PCIA pump (48-h cycle). The pump was initiated 15 min before surgery, with settings of background infusion 2 ml/h, bolus dose 2 ml, and lockout interval 15 min. Patients could self-administer boluses when the numerical pain rating scale (NRS) score was ≥4, with repeated presses during lockout having no effect. For patients with an NRS score ≥4 after two effective boluses, hydromorphone 1 mg diluted in normal saline to 10 ml was administered as a slow push over 2-3 min.
Receives: Drug: hydrochloride hydromorphone + flurbiprofen axetil
conventional analgesiaActive comparatorGroup B received on-demand analgesia. When the NRS score was ≥4, flurbiprofen axetil 50 mg was administered intravenously, with intramuscular tramadol 100 mg added if analgesia was inadequate.
Receives: Drug: conventional analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perioperative numerical pain rating scale (NRS) score

    The NRS was used to assess pain intensity intraoperatively, immediately postoperatively, and at 1 h, 4 h, 8 h, 12 h, and 24 h postoperatively, with scores ranging 0-10 (0=no pain, 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain).

    Measured: From the start of the operation to 24 hours after the operation

Secondary outcomes (4)

  1. Surgical Duration

    Total time from puncture initiation to completion of dressing (min).

    Measured: From the start of the operation to the end of the operation

  2. Adverse Events

    Adverse events within 24 h postoperatively were recorded, including elevated ALBI scores, ALT and AST >2×ULN, nausea and vomiting, drowsiness and dizziness, pruritus, and urinary difficulty, with related indicator changes and incidence documented.

    Measured: From the start of the operation to 24 hours after the operation

  3. Analgesia Satisfaction

    At 24 h postoperatively, patients' subjective experiences were assessed using a 5-point Likert scale (5=very satisfied, 4=satisfied, 3=neutral, 2=dissatisfied, 1=very dissatisfied).

    Measured: At 24 hours postoperatively

  4. Cost-Effectiveness Analysis

    TACE perioperative analgesia costs plus postoperative hospitalization costs were used as the cost indicator (C), with analgesia satisfaction ≥4 as the effectiveness indicator (E). The average cost approach was used for incremental cost-effectiveness analysis (ΔC/ΔE).

    Measured: From the start of the operation to the end of perioperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2026
  2. Study start1 Aug 2024
  3. Primary completion30 Aug 2025
  4. Study completion30 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07315022
Sponsor's protocol ID
EMAT2025
Status last verified
Dec 2025
First submitted
5 Dec 2025
Last updated
2 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26827847

  • 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.

    PubMed 38669783

  • 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.

    PubMed 38876786

  • 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.

    PubMed 41063733

  • 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.

    PubMed 34405295

  • 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.

    PubMed 32884990

  • 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.

    PubMed 31938928

  • 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.

  • 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.

    PubMed 28648803

  • 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.

    PubMed 24937669

  • 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.

    PubMed 27529160

  • 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.

    PubMed 22357901

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing hydrochloride hydromorphone + flurbiprofen axetil and conventional analgesia in people with Enhanced Recovery After Surgery and Multimodal Analgesia, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perioperative numerical pain rating scale (NRS) score (time frame: From the start of the operation to 24 hours after the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07315022, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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Clinical Trial NCT07315022 | AzTrials