Postoperative Acute PainPhase 4NCT07801183
Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy
A Phase 4 study testing Anruikefon 1 μg/kg per dose Group and Anruikefon 100 μg per dose Group in people with Postoperative Acute Pain, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Acute Pain
- What is being tested?
- Anruikefon 1 μg/kg per dose Group and Anruikefon 100 μg per dose Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2026to 30 Jul 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years;
- American Society of Anesthesiologists (ASA) physical status classification I-III;
- Body mass index (BMI): 18 kg/m² ≤ BMI ≤ 30 kg/m²;
- Patients scheduled to undergo laparoscopic hepatectomy under general anesthesia with estimated operation duration ≤ 5 hours;
- Agree to participate in this trial and voluntarily sign the informed consent form.
Who cannot join
- Patients with a history of severe cardiopulmonary disease, neuropsychiatric disorders, digestive system diseases, chronic dizziness or vestibular dysfunction;
- Patients undergoing emergency surgery or trauma patients;
- Intraoperative conversion to open laparotomy;
- History of abdominal surgery within the past 3 months;
- Patients undergoing liver transplantation or with metastasis to other organs;
- Patients requiring synchronous resection of organs other than the gallbladder, extrahepatic bile ducts and intestines due to intraoperative clinical needs;
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- Severe renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73 m²);
- Laboratory findings or clinical evaluation indicating hypothyroidism or hypokalemia graded ≥ Grade 3 per CTCAE v6.0;
- Subjects who experienced nausea, retching or vomiting within 24 hours before anesthesia induction (excluding those caused by bowel preparation);
- Patients expected to require postoperative mechanical ventilation via endotracheal intubation or naso/orogastric tube placement for more than 24 hours;
- Known allergy or contraindication to opioids and other anesthetics, antiemetics that may be administered during the trial.
- Use of drugs with analgesic, antiemetic or anti-inflammatory effects with unknown half-life within 14 days prior to randomization; or the interval between the last administration and randomization is shorter than 5 half-lives or the duration of drug effect (whichever is longer). Such drugs include, but are not limited to, opioid analgesics, non-opioid analgesics, antiemetics (or drugs with antiemetic properties), sedative-hypnotics, sedative anesthetics, glucocorticoids and other drugs with analgesic or antiemetic effects.
- Subjects with any other factors deemed by the investigator(s) to render them unsuitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Changzhen Shang, +86-20-3407 0701, shchzh2@mail.sysu.edu.cn
About this study
Official title: Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy:A Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial
A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.
Read the detailed description
A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.
- Conditions
- Postoperative Acute Pain
- Being tested
- Anruikefon 1 μg/kg per dose Group, Anruikefon 100 μg per dose Group, Control group
- Keywords
- postoperative acute pain, laparoscopic hepatectomy, Anrikefon
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anruikefon 1 μg/kg per dose GroupDrug
Anruikefon 1 μg/kg/dose, once every 8 hours (q8h), for a total of 6 doses.
Anruikefon 100 μg per dose GroupDrug
Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.
Control groupDrug
0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
| Study group | Role | What they receive |
|---|---|---|
| Anruikefon 1 μg/kg per dose Group | Experimental | Anruikefon 1 μg/kg per dose, once every 8 hours (q8h), for a total of 6 doses. Receives: Drug: Anruikefon 1 μg/kg per dose Group |
| Anruikefon 100 μg per dose Group | Experimental | Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses. Receives: Drug: Anruikefon 100 μg per dose Group |
| Placebo Group | Placebo comparator | 0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses. Receives: Drug: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of sufentanil via PCIA within 48 hours after the first study drug administration
Measured: 0-48 hours post first study drug dose
Secondary outcomes (19)
Proportion of rescue analgesia
Measured: Within0-24 hours and 0-48 hours after the first study drug administration
Cumulative consumption dose of rescue analgesia
Measured: within 0-24 hours and 0-48 hours after the first study drug administration
Time from end of surgery to first passage of flatus (hours)
Measured: Throughout the inpatient hospital stay after surgery, from the end of surgery until the first flatus occurs
Time from end of surgery to first defecation (hours)
Measured: Throughout the inpatient hospital stay after surgery, from the end of surgery until the first defecation occurs
Time from the end of surgery to first ambulation (hours)
Measured: Throughout the inpatient hospital stay after surgery, from the end of surgery until the first ambulation occurs
Incidence of nausea, vomiting and PONV
Measured: Within 48 hours after the first study drug administration
Patient satisfaction score for analgesia
Measured: Within 48 hours after the first study drug administration
Proportion of subjects with resting numerical rating scale (NRS) pain score ≥ 3
Measured: Within 0-24 hours and 0-48 hours after the first study drug administration
Resting numerical rating scale (NRS) pain score
Measured: At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
Movement-evoked numerical rating scale (NRS) pain score
Measured: At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
Incidence of rescue antiemetic treatment
Measured: Within 48 hours after the first study drug administration
Cumulative dose of rescue antiemetic treatment
Measured: Within 48 hours after the first study drug administration
Incidence of serious adverse events and study drug-related adverse events
Measured: Throughout the inpatient hospital stay after surgery, from the end of surgery until hospital discharge
Sleep quality score assessed using the Richards-Campbell Sleep Questionnaire (RCSQ; score range 0-100, higher scores indicate better sleep quality)
Measured: On the single night following the first administration of study drug
Cumulative consumption of sufentanil delivered via patient-controlled intravenous analgesia (PCIA)
Measured: Within 24 hours after the first study-drug administration
Serum biomarker concentrations: alanine transaminase (ALT), aspartate transaminase (AST), albumin (ALB), total bilirubin (TBIL), direct bilirubin (DBIL), indirect bilirubin (IBIL), international normalized ratio (INR)
Measured: Preoperative baseline (prior to surgical incision), and within the interval from 24 hours to 48 hours after the first administration of study drug
Proportion of subjects with movement-evoked Numerical Rating Scale (NRS) pain score ≥ 3
Measured: Within 0-24 hours and 0-48 hours after the first study-drug administration
Overall patient recovery quality score evaluated via the QoR-15 questionnaire (score range 0-150; higher scores indicate better recovery quality)
Measured: Within 48 hours after the first study-drug administration
Cumulative opioid consumption, converted to intravenous morphine milligram equivalents (MME)
Measured: Within the interval from 0 hours to 24 hours after the first administration of study drug, and within the interval from 0 hours to 48 hours after the first administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start30 Aug 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Changzhen Shang, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801183
- Sponsor's protocol ID
- SYSKY-2026-307-03
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy:A Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07801183
- Acronym / sponsor ID
- SYSKY-2026-307-03
- Conditions
- Postoperative Acute Pain
- Keywords
- postoperative acute pain, laparoscopic hepatectomy, Anrikefon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.
Detailed description
A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anruikefon 1 μg/kg per dose Group | Experimental | Drug: Anruikefon 1 μg/kg per dose GroupAnruikefon 1 μg/kg per dose, once every 8 hours (q8h), for a total of 6 doses. |
| Anruikefon 100 μg per dose Group | Experimental | Drug: Anruikefon 100 μg per dose GroupAnruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses. |
| Placebo Group | Placebo comparator | Drug: Control group0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥ 18 years;
- American Society of Anesthesiologists (ASA) physical status classification I-III;
- Body mass index (BMI): 18 kg/m² ≤ BMI ≤ 30 kg/m²;
- Patients scheduled to undergo laparoscopic hepatectomy under general anesthesia with estimated operation duration ≤ 5 hours;
- Agree to participate in this trial and voluntarily sign the informed consent form.
Key exclusion criteria (13 listed)
- Patients with a history of severe cardiopulmonary disease, neuropsychiatric disorders, digestive system diseases, chronic dizziness or vestibular dysfunction;
- Patients undergoing emergency surgery or trauma patients;
- Intraoperative conversion to open laparotomy;
- History of abdominal surgery within the past 3 months;
- Patients undergoing liver transplantation or with metastasis to other organs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anruikefon 1 μg/kg per dose GroupAnruikefon 1 μg/kg/dose, once every 8 hours (q8h), for a total of 6 doses. | Drug | Anruikefon 1 μg/kg per dose Group |
| Anruikefon 100 μg per dose GroupAnruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses. | Drug | Anruikefon 100 μg per dose Group |
| Control group0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses. | Drug | Placebo Group |
Primary outcome
Consumption of sufentanil via PCIA within 48 hours after the first study drug administration
Time frame: 0-48 hours post first study drug dose
19 secondary outcomes
Proportion of rescue analgesia
Time frame: Within0-24 hours and 0-48 hours after the first study drug administration
Cumulative consumption dose of rescue analgesia
Time frame: within 0-24 hours and 0-48 hours after the first study drug administration
Time from end of surgery to first passage of flatus (hours)
Time frame: Throughout the inpatient hospital stay after surgery, from the end of surgery until the first flatus occurs
Time from end of surgery to first defecation (hours)
Time frame: Throughout the inpatient hospital stay after surgery, from the end of surgery until the first defecation occurs
Time from the end of surgery to first ambulation (hours)
Time frame: Throughout the inpatient hospital stay after surgery, from the end of surgery until the first ambulation occurs
Incidence of nausea, vomiting and PONV
Time frame: Within 48 hours after the first study drug administration
Patient satisfaction score for analgesia
Time frame: Within 48 hours after the first study drug administration
Proportion of subjects with resting numerical rating scale (NRS) pain score ≥ 3
Time frame: Within 0-24 hours and 0-48 hours after the first study drug administration
Resting numerical rating scale (NRS) pain score
Time frame: At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
Movement-evoked numerical rating scale (NRS) pain score
Time frame: At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
Incidence of rescue antiemetic treatment
Time frame: Within 48 hours after the first study drug administration
Cumulative dose of rescue antiemetic treatment
Time frame: Within 48 hours after the first study drug administration
Incidence of serious adverse events and study drug-related adverse events
Time frame: Throughout the inpatient hospital stay after surgery, from the end of surgery until hospital discharge
Sleep quality score assessed using the Richards-Campbell Sleep Questionnaire (RCSQ; score range 0-100, higher scores indicate better sleep quality)
Time frame: On the single night following the first administration of study drug
Cumulative consumption of sufentanil delivered via patient-controlled intravenous analgesia (PCIA)
Time frame: Within 24 hours after the first study-drug administration
Serum biomarker concentrations: alanine transaminase (ALT), aspartate transaminase (AST), albumin (ALB), total bilirubin (TBIL), direct bilirubin (DBIL), indirect bilirubin (IBIL), international normalized ratio (INR)
Time frame: Preoperative baseline (prior to surgical incision), and within the interval from 24 hours to 48 hours after the first administration of study drug
Proportion of subjects with movement-evoked Numerical Rating Scale (NRS) pain score ≥ 3
Time frame: Within 0-24 hours and 0-48 hours after the first study-drug administration
Overall patient recovery quality score evaluated via the QoR-15 questionnaire (score range 0-150; higher scores indicate better recovery quality)
Time frame: Within 48 hours after the first study-drug administration
Cumulative opioid consumption, converted to intravenous morphine milligram equivalents (MME)
Time frame: Within the interval from 0 hours to 24 hours after the first administration of study drug, and within the interval from 0 hours to 48 hours after the first administration of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Changzhen Shang principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anruikefon 1 μg/kg per dose Group and Anruikefon 100 μg per dose Group in people with Postoperative Acute Pain, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 5 inclusion and 13 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: opening soon, as of the sponsor's last update on 3 Sep 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Changzhen Shang (+86-20-3407 0701, shchzh2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumption of sufentanil via PCIA within 48 hours after the first study drug administration (time frame: 0-48 hours post first study drug dose). 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 3 Sep 2026.