Preventive Analgesia With Anrikefon in Laparoscopic Cholecystectomy

NCT07566663 | Not Yet Recruiting

• 1 other identifier: Linyanshen[2026]008-002
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Preventive Analgesia; Laparoscopic Cholecystectomy; Postoperative Acute Pain; Visceral Pain; Anrikefon

Outcome Measures

Primary Outcomes (1)

• The time-weighted sum of pain intensity differences over 0-24 hours postoperatively of visceral pain

  The time-weighted sum of pain intensity differences over 0-24 hours postoperatively (SPID₀-₂₄h) will be calculated through Numerical Rating Scale (NRS) scores. NRS scores ranges from 0 to 10 of visceral pain. It will be assessed immediately after surgery, and at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, and 24 hours postoperatively. SPID₀-₂₄h will be calculated based on the NRS scores at each time point. Higher SPID₀-₂₄h will indicate better analgesic efficacy. The formula is: SPID₀-₂₄h = Σ\[(Baseline NRS - NRS at time point) × Δt\]. Δt represents the time interval between two consecutive assessments.

  From the end of surgery to 24 hours postoperatively

Secondary Outcomes (11)

• The time-weighted sum of pain intensity differences over 0-24 hours postoperatively of Incisional pain

  From the end of surgery to 24 hours postoperatively

• The Numerical Rating Scale scores for visceral pain and incisional pain

  From the end of surgery to 24 hours postoperatively

• Duration of postoperative incisional pain and visceral pain

  From the end of surgery to 72 hours postoperatively

• Total Oxycodone consumption of the postoperative analgesia pump

  From the end of surgery to 48 hours postoperatively

• Total Parecoxib sodium for rescue analgesia after surgery

  From the end of surgery to 72 hours postoperatively

Other Outcomes (1)

• the levels of IL-6, CRP, and PGE2

  1 day before surgery and 24 hours after surgery

Study Arms (2)

Preventive Analgesia Group

EXPERIMENTAL

Patients in Preventive Analgesia Group will receive intravenous Anrikefon (1 μg/kg) at 15 minutes before anesthesia induction. Each bolus administration should be completed within 2 minutes ± 5 seconds.

Drug: Anrikefon for Preventive Analgesia

Bridging Analgesia Group

ACTIVE COMPARATOR

Patients in Bridging Analgesia Group will receive intravenous Anrikefon (1 μg/kg) immediately after the gallbladder is dissected from the liver bed. Each bolus administration should be completed within 2 minutes ± 5 seconds.

Drug: Anrikefon for bridging analgesia

Interventions

Anrikefon for Preventive Analgesia DRUG

The Preventive Analgesia Group will receive intravenous Anrikefon (1 μg/kg) 15 minutes before anesthesia induction. Each bolus administration should be completed within 2 minutes ± 5 seconds.

Preventive Analgesia Group

Anrikefon for bridging analgesia DRUG

The Bridging Analgesia Group will receive intravenous Anrikefon (1 μg/kg) immediately after the gallbladder is removed from the liver bed. Each bolus administration should be completed within 2 minutes ± 5 seconds.

Bridging Analgesia Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status classification I-III;
• Age 18-65 years;
• Scheduled for elective laparoscopic cholecystectomy;
• Voluntary signed informed consent;
• BMI between 18-28 kg/m²;
• No history of general anesthesia surgery within the past 3 months.

You may not qualify if:

• Severe cardiovascular disease, respiratory disease, or psychiatric disorders;
• Severe renal insufficiency;
• Recent use of diuretics or compound medications containing diuretics;
• Continuous use of opioid analgesics for more than 10 days within the past 3 months;
• Use of medications with unknown half-life affecting analgesic efficacy within 14 days prior to randomization;
• Pregnant women, lactating women, or those planning pregnancy in the near future;
• History of hypersensitivity to study medications.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Haisco Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Pain, Postoperative; Visceral Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nociceptive Pain

Study Officials

• Wei Xiao

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Tianlong Wang

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Xiao, PhD

CONTACT

+8613810971299; kitten15@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will employ a prospective, parallel-group, randomized controlled, single-center design with double-blind assessment. Randomization will occur prior to surgery.It will use computer-generated random numbers to assign patients in a 1:1 ratio to either the Preventive Analgesia group or the Bridging Analgesia group. Allocation concealment will follow a rigorous sequential procedure: randomization codes will be placed in sequentially numbered, opaque envelopes attached to case report forms. When an eligible patient is ready for anesthesia. The anesthesiologist will prepare and administer the study drug according to the assigned timing protocol. Group allocation will bes kept confidential from patients and statisticians.

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)