Anrikefon Injection for Postoperative Pain After Laparoscopic Gastrectomy in Gastric Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, investigator-initiated trial evaluates the safety and efficacy of Anrikefon, a peripherally acting kappa opioid receptor agonist, for postoperative analgesia after total laparoscopic distal gastrectomy. Participants are adults with gastric cancer, undergoing elective surgery, and are randomized to receive Anrikefon either as an IV bolus or infusion or to placebo. The study will monitor pain scores, analgesic use, and adverse events to determine whether Anrikefon provides better pain relief with fewer central opioid-related side effects. The trial is conducted at Tianjin Medical University Cancer Institute and Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged between 18 and 75 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.

Where it's running

• Tianjin Medical University Cancer Institute & Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Han Liang, MS — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Bin Ke
• Email: binke@tmu.edu.cn
• Phone: 022-23340123-1061

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.