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Postoperative PainANIPAPNCT07566663

Preventive Analgesia With Anrikefon in Laparoscopic Cholecystectomy

A study testing Anrikefon for Preventive Analgesia and Anrikefon for bridging analgesia in people with Postoperative Pain, run by Xuanwu Hospital, Beijing at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Postoperative Pain
What is being tested?
Anrikefon for Preventive Analgesia and Anrikefon for bridging analgesia
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
274 participants
Where
1 siteChina
Study dates
2 Jun 2026to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wei Xiao, PhD contact

+8613810971299

kitten15@126.com

China1 site, 1 recruiting
  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053

    Wei Xiao, 8613810971299, kitten15@126.com

    Recruiting

Other trials in China

About this study

Official title: Effect of Preventive Analgesia With Anrikefon on Postoperative Acute Pain and Rehabilitation Process in Adult Patients Undergoing 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.

Read more

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.

Read the detailed description

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).

Being tested
Anrikefon for Preventive Analgesia, Anrikefon for bridging analgesia
Keywords
Preventive Analgesia, Laparoscopic Cholecystectomy, Postoperative Acute Pain, Visceral Pain, Anrikefon
Medical subject headings
Pain, Postoperative, Visceral Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anrikefon for Preventive AnalgesiaDrug

    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 analgesiaDrug

    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.

Study groups in NCT07566663
Study groupRoleWhat they receive
Preventive Analgesia GroupExperimentalPatients 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.
Receives: Drug: Anrikefon for Preventive Analgesia
Bridging Analgesia GroupActive comparatorPatients 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.
Receives: Drug: Anrikefon for bridging analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From the end of surgery to 24 hours postoperatively

Secondary outcomes (11)
  1. The time-weighted sum of pain intensity differences over 0-24 hours postoperatively of Incisional 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 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.

    Measured: From the end of surgery to 24 hours postoperatively

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

    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.

    Measured: From the end of surgery to 24 hours postoperatively

  3. Duration of postoperative incisional pain and visceral pain

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

    Measured: From the end of surgery to 72 hours postoperatively

  4. Total Oxycodone consumption of the postoperative analgesia pump

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

    Measured: From the end of surgery to 48 hours postoperatively

  5. Total Parecoxib sodium for rescue analgesia after surgery

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

    Measured: From the end of surgery to 72 hours postoperatively

  6. 15-item Quality of Recovery scale

    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.

    Measured: at Day 1 and Day 3 after surgery

  7. Recovery of gastrointestinal function

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

    Measured: From the end of surgery to Day 3 after surgery

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

    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.

    Measured: 24 hours, 48 hours, and 72 hours after surgery

  9. Length of hospital stay

    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.

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

  10. Rate of adverse reactions and complications

    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.

    Measured: From anesthesia induction to 72 hours after surgery

  11. 30 days mortality

    any death of patients occur in 30 days after surgery

    Measured: from the end of surgery to 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start2 Jun 2026
  3. Primary completion31 May 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
274 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07566663
Sponsor's protocol ID
Linyanshen[2026]008-002
Acronym
ANIPAP
Status last verified
Jun 2026
First submitted
20 Apr 2026
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Anrikefon for Preventive Analgesia and Anrikefon for bridging analgesia in people with Postoperative Pain, run by Xuanwu Hospital, Beijing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wei Xiao, PhD (+8613810971299, kitten15@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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