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A Study on the Efficacy and Safety of Anrikefon for Postoperative Pain Relief Following Laparoscopic Cholecystectomy

28 juillet 2026 mis à jour par: Affiliated Hospital of Guangdong Medical University

A Multicenter, Randomized, Parallel-Group Controlled Study Evaluating the Efficacy and Safety of Anrikefon in Postoperative Pain Management in Patients Undergoing Elective Laparoscopic Cholecystectomy Under General Anesthesia

This study is a multicenter, randomized, 1:1 parallel-group controlled clinical trial designed to evaluate the efficacy and safety of Anrikefon for postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy (LC) under general anesthesia. Enrolled patients were randomly assigned to two groups (the Anrikefon group and the dizocine group) and received regular intravenous administration of the respective medication following the corresponding surgical procedure. The primary efficacy endpoint was the Quality of Recovery (QoR-15 score) at 24 hours postoperatively, combined with the Numerical Rating Scale (NRS), the Brief Pain Inventory (BPI), sleep quality (RCSQ), and postoperative recovery progress (time to first meal, first flatus, and first ambulation, etc.) for a comprehensive evaluation of efficacy; At the same time, safety indicators-including adverse events (such as nausea and vomiting, and shoulder and back pain), vital signs, and laboratory test results-were systematically monitored during the follow-up period to comprehensively evaluate the clinical utility of this protocol.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

144

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Guangdong
      • Zhanjiang, Guangdong, Chine, 524001
        • Affiliated Hospital of Guangdong Medical University
        • Contact:
      • Zhanjiang, Guangdong, Chine, 524001
        • The Second Affiliated Hospital of Guangdong Medical University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • 1.18 ≤ Age ≤ 70 years, no gender restriction.
  • 2.American Society of Anesthesiologists (ASA) physical status classification I-II.
  • 3.18 kg/m² ≤ BMI ≤ 30 kg/m².
  • 4.Subjects undergoing elective LC under general anesthesia, with an estimated -surgical duration of ≤2 hours (including 1h).
  • 5.Voluntarily agree to participate in the study and sign the informed consent form (ICF).

Exclusion Criteria:

  • 1.History of allergy to nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, or intraoperative anesthetics specified in the protocol.
  • 2.Severe systemic diseases that, in the investigator's judgment, may significantly increase surgical risk or interfere with pain assessment (e.g., uncontrolled hypertension [SBP ≥170 mmHg and/or DBP ≥105 mmHg], uncontrolled hyperglycemia [fasting blood glucose ≥11.1 mmol/L], recent severe respiratory tract infection, severe gastritis, gastric/duodenal ulcers, upper abdominal surgery within 3 months, severe hepatic impairment [Child-Pugh score >9], chronic kidney disease [eGFR <60 mL/min/1.73m²]).
  • 3.Substance abuse: Current drug or alcohol dependency.
  • 4.Special populations: Pregnant or lactating women; any other conditions deemed unsuitable by the investigator.
  • 5.Acute severe cholecystitis attack within the past 7 days, or subjects in whom malignant gallbladder lesions cannot be ruled out.
  • 6.Presence of sleep disorders requiring pharmacological intervention; concomitant psychiatric disorders.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Anrikefon Group
  • Subjects will undergo screening according to the trial flowchart. Successfully screened subjects will obtain a randomization number prior to administration and will be divided into two groups: the Anrikefon group and the Dezocine group.
  • Anrikefon Group: 1.0 µg/kg per dose, administered by intravenous bolus injection every 8 hours at 0, 8, and 16 hours postoperatively, for a total of 3 doses. Specific preparation: Dilute 1.0 µg/kg of Anrikefon with 0.9% sodium chloride injection to a total volume of 10 mL.
Médicament: Anrikefon
1.0 µg/kg per dose, administered by intravenous bolus injection every 8 hours at 0, 8, and 16 hours postoperatively, for a total of 3 doses. Specific preparation: Dilute 1.0 µg/kg of Anrikefon with 0.9% sodium chloride injection to a total volume of 10 mL.
Comparateur actif: Dezocine Group
  • Subjects will undergo screening according to the trial flowchart. Successfully screened subjects will obtain a randomization number prior to administration and will be divided into two groups: the Anrikefon group and the Dezocine group.
  • Dezocine Group: 5 mg/dose, IV bolus, q8h. Administered at 0h, 8h, and 16h postoperatively for a total of 3 doses.
Médicament: Dezocine
5 mg/dose, IV bolus, q8h. Administered at 0h, 8h, and 16h postoperatively for a total of 3 doses.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Quality of Recovery-15 (QoR-15) scale at 24 hours postoperatively.
Délai: 24 hours after surgery
The QoR-15 scale was used 24 hours after surgery to assess the quality of patients' postoperative recovery. The total score of the QoR-15 scale ranges from 0 to 150, with higher scores indicating a better quality of postoperative recovery.
24 hours after surgery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Resting and movement pain Numeric Rating Scale (NRS) Area Under the Curve (AUC 0-24h) after the initial dose
Délai: 24 hours after surgery
Pain intensity was assessed using the 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (the most intense pain imaginable). NRS scores were recorded at multiple time points between the first postoperative administration and 24 h ± 1 h, both while the subject was at rest and when turning over, to calculate the AUC 0-24 h. A higher AUC value indicates more severe cumulative pain over 24 hours (a worse outcome).
24 hours after surgery
Resting and movement (turning over) postoperative pain scores using the Numeric Rating Scale (NRS) at 0h, 2h, 8h, 16h, and 24h postoperatively.
Délai: 24 hours after surgery
Pain intensity was assessed using an 11-point Numerical Rating Scale (NRS), with scores ranging from 0 (no pain) to 10 (the most intense pain imaginable); higher scores indicate more severe pain (and a poorer prognosis). Participants' NRS scores were recorded at the following time points: within 5 minutes of the first postoperative medication administration, both at rest and while turning over; 2 hours ± 15 minutes after the first postoperative medication administration; 8 hours (within 30 minutes before the second postoperative medication administration); 16 hours (within 30 minutes before the last postoperative medication administration); and 24 hours ± 1 hour.
24 hours after surgery
Rescue analgesic utilization: Cumulative consumption of rescue analgesia (meperidine 75 mg) at 0-12h and 0-24h after the first dose, number of rescue interventions, time to first rescue, and the percentage of subjects not requiring rescue analgesia.
Délai: 24 hours after surgery
Record the cumulative dose of rescue analgesics (pethidine 75 mg) administered 0-12 hours and 0-24 hours after the patient's first postoperative dose, as well as the time at which rescue analgesics were first administered.
24 hours after surgery
Incidence of shoulder discomfort, back pain, nausea, and vomiting in each group.
Délai: 24 hours after surgery
During the medical interview, ask the patient whether they have experienced shoulder discomfort, back pain, nausea, or vomiting.
24 hours after surgery
Time to first oral intake, time to first flatus/defecation, and time to first ambulation.
Délai: 24 hours after surgery
The medical record documents the patient's mealtimes, times of flatulence and bowel movements, and times of getting out of bed to move around.
24 hours after surgery
Sleep quality on postoperative day 1 assessed by the Richards-Campbell Sleep Questionnaire (RCSQ).
Délai: 24 hours after surgery
Every morning upon waking, participants immediately used the Richards-Campbell Sleep Questionnaire (RCSQ) to review and evaluate their sleep from the previous night. The total RCSQ score is the average of its five items, with a scoring range from 0 (worst sleep) to 100 (best sleep); a higher score indicates better sleep quality (better outcome).
24 hours after surgery
Postoperative Brief Pain Inventory (BPI) Scores
Délai: 24 hours after surgery
Twenty-four hours after surgery, the Brief Pain Inventory (BPI) was used to assess participants' pain intensity and the extent to which pain interfered with their daily activities over the past 24 hours. The scale ranges from 0 to 10 points (0 indicates no pain/no interference, and 10 indicates the most intense pain imaginable/complete interference). A higher score indicates more severe pain and a greater impact on daily life (i.e., a worse outcome).
24 hours after surgery
Incidence and severity of adverse events (AEs).
Délai: 2 weeks post-surgery
Follow-up records document the occurrence and severity of adverse events in patients.
2 weeks post-surgery
12-Lead Electrocardiogram
Délai: Baseline and the 24 hours After Surgery
During the trial, 12-lead ECG examinations were performed at regular intervals to record the ECG diagnosis (normal/abnormal), ECG heart rate (beats per minute), and QT/Qtc/PR (ms).
Baseline and the 24 hours After Surgery
Cumulative use of antiemetics within 0-24 hours after the first postoperative dose in each group
Délai: 24 hours after surgery
Record and compare the total cumulative dose of antiemetic medications prescribed and administered to patients in each group within the first 24 hours after the initial postoperative dose.
24 hours after surgery
Proportion of patients in each group who received antiemetics within 0-24 hours after the first postoperative dose
Délai: 24 hours after surgery
Calculate and compare the percentage of patients in each group who required at least one dose of rescue antiemetic medication within the first 24 hours after the initial postoperative administration.
24 hours after surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Affiliated Hospital of Guangdong Medical University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

30 septembre 2028

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

12 juillet 2026

Première soumission répondant aux critères de contrôle qualité

28 juillet 2026

Première publication (Réel)

3 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Anrikefon LC01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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