NCT07566663 Preventive Analgesia With Anrikefon in Laparoscopic Cholecystectomy
| NCT ID | NCT07566663 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 274 participants |
| Start Date | 2026-06-02 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 274 participants in total. It began in 2026-06-02 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will determine the optimal timing for Anrikefon administration. It will also assess the quality of patient recovery. Laparoscopic cholecystectomy (LC) is a routine surgical procedure. However, the incidence of acute visceral and incision pain is high, reaching 50% to 70%. This pain significantly impairs patient recovery. Anrikefon is novel peripherally restricted κ-opioid receptor agonist. It has very low brain penetration. This property reduces central nervous system side effects and respiratory depression. Preventive analgesia blocks the transmission of nociceptive stimuli to the central nervous system. It reduces postoperative pain sensitization and intensity. Currently, research on Anrikefon for preventive analgesia in LC patients is limited. It impacts on the recovery process is not yet fully understood. This study will compare drug administration before anesthesia induction with intra-operative administration. Participants will be assigned to one of two groups with equal probability using computer-generated random numbers. Patients in the Preventive Analgesia group will receive Anrikefon injection 15 minutes before anesthesia induction. Bridging Analgesia group is the control group. Patients in this group will receive Anrikefon immediately after the gallbladder is detached from the liver. Both groups will receive the identical drug dosage of 1 μg/kg. Both treatment groups will receive identical care beyond the time of Anrikefon administration. All patients will undergo standardized anesthesia management. Parecoxib sodium 40 mg will be injected for rescue analgesia if NRS score \> 4. We will analyze the primary, secondary, and exploratory outcome measures after surgery, aiming to explore the optimal timing of Anrikefon and its impact on the patient's recovery process.
Eligibility Criteria
Inclusion Criteria: 1. ASA physical status classification I-III; 2. Age 18-65 years; 3. Scheduled for elective laparoscopic cholecystectomy; 4. Voluntary signed informed consent; 5. BMI between 18-28 kg/m²; 6. No history of general anesthesia surgery within the past 3 months. Exclusion Criteria: 1. Severe cardiovascular disease, respiratory disease, or psychiatric disorders; 2. Severe renal insufficiency; 3. Recent use of diuretics or compound medications containing diuretics; 4. Continuous use of opioid analgesics for more than 10 days within the past 3 months; 5. Use of medications with unknown half-life affecting analgesic efficacy within 14 days prior to randomization; 6. Pregnant women, lactating women, or those planning pregnancy in the near future; 7. History of hypersensitivity to study medications.
Contact & Investigator
Wei Xiao
PRINCIPAL INVESTIGATOR
Xuanwu Hospital, Beijing
Frequently Asked Questions
Who can join the NCT07566663 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07566663 currently recruiting?
Yes, NCT07566663 is actively recruiting participants. Contact the research team at kitten15@126.com for enrollment information.
Where is the NCT07566663 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07566663 clinical trial?
NCT07566663 is sponsored by Xuanwu Hospital, Beijing. The principal investigator is Wei Xiao at Xuanwu Hospital, Beijing. The trial plans to enroll 274 participants.