Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Totally Laparoscopic Radical Distal Gastrectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-22

Study Completion Date

2026-06-30

Brief Summary

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Anruikefen is a peripherally highly selective kappa receptor agonist that does not easily cross the blood-brain barrier, resulting in a low incidence of central adverse reactions such as respiratory depression, sedation, and addiction. As a Class 1 new drug, it was approved for marketing in China on May 13, 2025, and is indicated for the treatment of postoperative pain following abdominal surgery. Results from two Phase Ⅲ randomized controlled trials (RCTs) of Anruikefen have demonstrated its significant analgesic efficacy, with the incidence of postoperative nausea and vomiting (PONV) being 50% significantly lower than that in the placebo group, which confirms the favorable safety profile of Anruikefen Injection.

Therefore, this investigator-initiated trial (IIT) is designed to further verify the efficacy and safety of Anruikefen in patients undergoing total laparoscopic distal gastrectomy for gastric cancer.

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Detailed Description

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Conditions

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Gastrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo Group

Normal Saline via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Group Type PLACEBO_COMPARATOR

Placebo Group

Intervention Type DRUG

Normal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Anruikfen Intravenous Bolus Injection Group

Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Group Type EXPERIMENTAL

Anruikefen (Intravenous Bolus)

Intervention Type DRUG

Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Anruikefen Intravenous Infusion Group

Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.

Group Type EXPERIMENTAL

Anruikefen (Intravenous Infusion)

Intervention Type DRUG

Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.

Interventions

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Anruikefen (Intravenous Bolus)

Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Intervention Type DRUG

Anruikefen (Intravenous Infusion)

Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.

Intervention Type DRUG

Placebo Group

Normal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged between 18 and 70 years old (inclusive).
* American Society of Anesthesiologists (ASA) physical status classification Class I-III.
* Body Mass Index (BMI) ranging from 18 kg/m² to 30 kg/m² (inclusive).
* Patients scheduled for elective total laparoscopic distal gastrectomy for gastric cancer under general anesthesia, with surgical duration \< 5 hours.
* Surgical incision length \< 8 cm.
* Voluntarily agree to participate in the trial and sign the informed consent form.

Exclusion Criteria

* Patients undergoing emergency surgery or suffering from trauma.
* Patients who undergo conversion to open surgery or laparoscopically assisted distal gastrectomy for gastric cancer during the operation.
* Patients who refuse to receive Patient-Controlled Intravenous Analgesia (PCIA).
* Patients with a history of prior abdominal surgery.
* Patients expected to require prolonged endotracheal intubation after surgery.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No