- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07826806
Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Laparoscopic Hepatectomy
14. september 2026 oppdatert av: Tianjin Medical University Cancer Institute and Hospital
Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Laparoscopic Hepatectomy--A Single-center, Randomized, Controlled Clinical Study
Efficacy and safety of Anrikefon injection for the treatment of postoperative pain in patients undergoing laparoscopic hepatectomy--A single-center, randomized, controlled clinical study
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
108
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ping Chen, MD
- Telefonnummer: 13821017600
- E-post: sly178604@126.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Age between 18 and 75 years, any gender;
- American Society of Anesthesiologists (ASA) score of I or II;
- BMI between 18 kg/m² and 30 kg/m²;
- Patients scheduled for laparoscopic liver resection under general anesthesia, with surgery lasting less than 6 hours;
- Surgical incision less than 10 cm;
- Able to understand pain intensity assessment methods.
Participants understand the purpose and procedures of this study, voluntarily participate, and sign a written informed consent form.
Exclusion Criteria:
- Patients allergic to opioids, flurbiprofen ester, or any other ingredients in the investigational drugs.
- Patients expected to use continuous epidural analgesia or local block analgesia during the treatment period.
- Patients with a history of gastrointestinal ulcers or bleeding who need treatment.
- Patients undergoing emergency surgery or trauma.
- Patients whose surgery needs to be converted to open abdominal surgery.
- Patients unwilling to use patient-controlled intravenous analgesia (PCIA).
- Patients with a history of upper abdominal surgery.
- Patients expected to require postoperative continued intubation.
- Patients needing postoperative admission to the ICU.
- Patients with any of the following disease history or evidence before screening:
- Severe cardiovascular or pulmonary diseases (myocardial infarction, heart failure, or respiratory failure).
- Neurological or psychiatric history: brain injury, intracranial hypertension, schizophrenia, mania, etc., judged by the investigator as not suitable for the study.
- History of digestive diseases: intestinal obstruction or other digestive system diseases that may cause nausea or vomiting as judged by the investigator; accompanied by other severe digestive tract issues affecting digestion (e.g., severe constipation, duodenal stasis syndrome, etc.), or other digestive diseases evaluated by the investigator as unsuitable for the study.
- Patients with obvious chronic dizziness or diagnosed vestibular function disorders (other than motion sickness), including but not limited to peripheral vestibular syndrome or central vestibular syndrome.
- Patients who received neoadjuvant treatment before surgery.
- Patients who experienced nausea, retching, or vomiting within 24 hours before anesthesia induction (excluding bowel prep-related cases).
- Known allergy or contraindication to other anesthetics or antiemetics that may be used during the trial.
- Patients who used drugs with unclear half-lives that have analgesic or antiemetic effects within 14 days before randomization, or whose last use was less than 5 half-lives or the drug's effective duration (whichever is longer), including but not limited to opioids, non-opioid analgesics, antiemetics (or drugs with antiemetic effects), sedatives, anesthetics, corticosteroids, and other similar drugs.
- Patients needing dialysis or who have alcoholism during treatment.
- Pregnant or breastfeeding women, or those planning pregnancy during the study period or within 3 months after study completion.
- Subjects the investigator believes have any other factor making them unsuitable for this clinical study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Anruikefen
|
For patients undergoing laparoscopic liver resection, randomization is completed within 2 hours after surgery.
Within 30 minutes after successful randomization, they receive their first injection of either Anruikefen or Flurbiprofen Ester.
After the first dose, at 8±1h, 16±1h, 24±1h, 32±1h, 40±1h, 48±1h, 56±1h, and 64±1h, each participant is given a corresponding dose of Anruikefen IV infusion
|
|
Placebo komparator: Flurbiprofen Ester
|
For patients undergoing laparoscopic liver resection, randomization is completed within 2 hours after surgery.
Within 30 minutes after successful randomization, they receive their first injection of either Anruikefen or Flurbiprofen Ester.
After the first dose, at 8±1h, 16±1h, 24±1h, 32±1h, 40±1h, 48±1h, 56±1h, and 64±1h, each participant is given a corresponding dose of Flurbiprofen Ester IV infusion.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
1. Area under the NRS pain score curve 24 hours after medication (AUC-NRS24)
Tidsramme: 24 hours after surgery
|
24 hours after surgery
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Pain intensity at rest and during movement (assess pain scores at 30 min, 1 h, 3 h, 6 h, 12 h, 24 h, 48 h, and 72 h after the first dose).
Tidsramme: 0-72 hours after surgery
|
0-72 hours after surgery
|
|
Pain intensity difference (PID) at 30 min, 1, 3, 6, 12, 24, 48, and 72 h after dosing. Pain was assessed by NRS (0-10; 0=no pain, 10=severe pain). PID = baseline score (pre-dose/pre-op, 0 h) minus score at each time point. Unit: points.
Tidsramme: 0-72 hours after surgery
|
0-72 hours after surgery
|
|
Sum of Pain Intensity Difference (SPID) at 30 min, 1, 3, 6, 12, 24, 48, and 72 h post-dose. NRS (0-10; 0=no pain, 10=worst pain) assessed pain. TPID = baseline score (pre-dose, 0 h) - score at each time point. Unit: points.
Tidsramme: 0-72 hours after surgery
|
0-72 hours after surgery
|
|
Total Sufentanil dose administered via PCIA pump within 24 hours post-surgery. Measurement tool: PCIA pump (or electronic medical record). Measurement unit: micrograms (μg).
Tidsramme: 24 hours after surgery
|
24 hours after surgery
|
|
Baseline, then assess NRS scores (visceral pain, incision pain, shoulder pain) at 30 min, 1 h, 3 h, 6 h, 12 h, 24 h, 48 h, and 72 h after the first dose.
Tidsramme: 0-72 hours after surgery
|
0-72 hours after surgery
|
|
Use of rescue pain medication: cumulative usage of rescue pain medication (morphine injection mg) at 072h after the first dose
Tidsramme: 0-72 hours after surgery
|
0-72 hours after surgery
|
|
The proportion of patients needing rescue pain relief within 72 hours after the first dose and the total amount of rescue medication used
Tidsramme: 0-72 hours after surgery
|
0-72 hours after surgery
|
|
Incidence of nausea, vomiting, and PONV within 72 hours after the first dose
Tidsramme: 0-72 hours after surgery
|
0-72 hours after surgery
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. desember 2027
Studiet fullført (Antatt)
1. desember 2027
Datoer for studieregistrering
Først innsendt
8. september 2026
Først innsendt som oppfylte QC-kriteriene
14. september 2026
Først lagt ut (Faktiske)
17. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Nevroatferdsmanifestasjoner
- Perseptuelle forstyrrelser
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Agnosia
- Organiske kjemikalier
- Hydrokarboner
- Hydrokarboner, syklisk
- Syrer, acyklisk
- Karboksylsyrer
- Hydrokarboner, aromatisk
- Benzenderivater
- Propionater
- Bifenylforbindelser
- Flurbiprofen
Andre studie-ID-numre
- E20261121
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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