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NCT Number: NCT07566663

Preventive Analgesia With Anrikefon in Laparoscopic Cholecystectomy

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Location contact

Wei Xiao

CONTACT

[email protected]

8613810971299

About this study

This study is a prospective, double-blinded, randomized controlled study. Adult patients (18-65 years old) who are planning to receive Laparoscopic Cholecystectomy will be enrolled into this study, and will be randomly divided according to 1:1. They will be named the preventive analgesia group and the bridging analgesia group. Primary end point is the time-weighted sum of pain intensity differences over 0-24 hours postoperatively (SPID₀-₂₄h) , which will be calculated according to the NRS scores at every time point(after surgery immediately ,15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, and 24 hours).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: From the end of surgery to 24 hours postoperatively

    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.

Secondary outcomes

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

    Time frame: From the end of surgery to 24 hours postoperatively

    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 incisional 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.

  2. The Numerical Rating Scale scores for visceral pain and incisional pain

    Time frame: From the end of surgery to 24 hours postoperatively

    The Numerical Rating Scale (NRS) scores ranges from 0 to 10. NRS scores of visceral pain and incisional pain will be recorded immediately after surgery, and 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, and 24 hours postoperatively. Higher scores will indicate more severe pain.

  3. Duration of postoperative incisional pain and visceral pain

    Time frame: From the end of surgery to 72 hours postoperatively

    The duration from surgery completion to the timepointing when NRS score is< 3 .

  4. Total Oxycodone consumption of the postoperative analgesia pump

    Time frame: From the end of surgery to 48 hours postoperatively

    The consumption of Oxycodone in the patient-controlled analgesia (PCA) pump will be recorded.

  5. Total Parecoxib sodium for rescue analgesia after surgery

    Time frame: From the end of surgery to 72 hours postoperatively

    If patients' NRS score was greater than 4, they will receive Parecoxib for rescue analgesia. The total dose of parecoxib will be recorded.

  6. 15-item Quality of Recovery scale

    Time frame: at Day 1 and Day 3 after surgery

    15-item Quality of Recovery scale (QOR-15) is used to assess postoperative recovery quality. The total score ranging from 0 to 150. Higher scores will indicate better postoperative recovery and lower scores will indicate poorer recovery.

  7. Recovery of gastrointestinal function

    Time frame: From the end of surgery to Day 3 after surgery

    The duration from end of surgery to first flatus and first oral intake .

  8. Intake, Feeling nauseated, Emesis, Exam, and Duration of symptoms scoring system score

    Time frame: 24 hours, 48 hours, and 72 hours after surgery

    Intake, Feeling nauseated, Emesis, Exam, and Duration of symptoms scoring system (I-FEED) . The I-FEED score will assess postoperative gastrointestinal function based on Intake, Feeling nauseated, Emesis, physical Exam, and Duration of symptoms. Total score ranges from 0 to 12. Higher scores will indicate worse postoperative nausea and vomiting (PONV) status.

  9. Length of hospital stay

    Time frame: From the day of hospital admission to the day of discharge, on anverage of 3-5 days.

    The duration of hospitalization will be calculated from the day of hospital admission to the day of discharge. The total number of hospital days will be recorded.

  10. Rate of adverse reactions and complications

    Time frame: From anesthesia induction to 72 hours after surgery

    Adverse reactions will include postoperative nausea and vomitting, Constipation, Sedation, Somnolence, Respiratory Depression, Psychiatric Symptoms, Urinary Retention, Allergic Reactions, Intraoperative Awareness, Intraoperative Hypotension, Intraoperative Hypertension, Intraoperative Bradycardia, Intraoperative Tachycardia, Laryngospasm, Anaphylaxis, Postoperative Hypotension, Postoperative Hypertension, Postoperative Bradycardia, and Postoperative Tachycardia. Complications will include Arrhythmia, Cardiac Arrest, Myocardial Infarction, Myocardial Injury, Pneumonia, Cardiogenic Pulmonary Edema, Pulmonary Embolism, Delirium, Stroke, Acute Kidney Injury, Gastrointestinal Bleeding, Paralytic Ileus, Deep Vein Thrombosis and Infection.

  11. 30 days mortality

    Time frame: from the end of surgery to 30 days after surgery

    any death of patients occur in 30 days after surgery

Other outcomes

  1. the levels of IL-6, CRP, and PGE2

    Time frame: 1 day before surgery and 24 hours after surgery

    Blood plasma will be collected from patients at 1 day before surgery and 24 h after surgery to measure the levels of interleukin-6 (IL-6), C-reactive protein (CRP), and prostaglandin E2 (PGE2) by ELISA

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Xiao, PhD

CONTACT

[email protected]

+8613810971299

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

Registry information

Official study title

Effect of Preventive Analgesia With Anrikefon on Postoperative Acute Pain and Rehabilitation Process in Adult Patients Undergoing Laparoscopic Cholecystectomy

Acronym: ANIPAP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 5, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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