Gallbladder StonesPhase 2NCT07741188
A Study on the Efficacy and Safety of Anrikefon for Postoperative Pain Relief Following Laparoscopic Cholecystectomy
A Phase 2 study testing Anrikefon and Dezocine in people with Gallbladder Stones and Gallbladder Polyps, run by Affiliated Hospital of Guangdong Medical University at 2 sites in China.
Trial summary
This study is a multicenter, randomized, 1:1 parallel-group controlled clinical trial designed to evaluate the efficacy and safety of Anrikefon for postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy (LC) under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gallbladder Stones, Gallbladder Polyps
- What is being tested?
- Anrikefon and Dezocine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Phase 2
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.18 ≤ Age ≤ 70 years, no gender restriction.
- 2.American Society of Anesthesiologists (ASA) physical status classification I-II.
- 3.18 kg/m² ≤ BMI ≤ 30 kg/m².
- 4.Subjects undergoing elective LC under general anesthesia, with an estimated -surgical duration of ≤2 hours (including 1h).
- 5.Voluntarily agree to participate in the study and sign the informed consent form (ICF).
Who cannot join
- 1.History of allergy to nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, or intraoperative anesthetics specified in the protocol.
- 2.Severe systemic diseases that, in the investigator's judgment, may significantly increase surgical risk or interfere with pain assessment (e.g., uncontrolled hypertension [SBP ≥170 mmHg and/or DBP ≥105 mmHg], uncontrolled hyperglycemia [fasting blood glucose ≥11.1 mmol/L], recent severe respiratory tract infection, severe gastritis, gastric/duodenal ulcers, upper abdominal surgery within 3 months, severe hepatic impairment [Child-Pugh score >9], chronic kidney disease [eGFR <60 mL/min/1.73m²]).
- 3.Substance abuse: Current drug or alcohol dependency.
- 4.Special populations: Pregnant or lactating women; any other conditions deemed unsuitable by the investigator.
- 5.Acute severe cholecystitis attack within the past 7 days, or subjects in whom malignant gallbladder lesions cannot be ruled out.
- 6.Presence of sleep disorders requiring pharmacological intervention; concomitant psychiatric disorders.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524001
Wei Dai, Ph.D., M.D., +86 13828264321, dwgdmufy@gdmu.edu.cn
The Second Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524001
Lai Hui Miao, 0759-2372816, 627225370@qq.com
About this study
Official title: A Multicenter, Randomized, Parallel-Group Controlled Study Evaluating the Efficacy and Safety of Anrikefon in Postoperative Pain Management in Patients Undergoing Elective Laparoscopic Cholecystectomy Under General Anesthesia
This study is a multicenter, randomized, 1:1 parallel-group controlled clinical trial designed to evaluate the efficacy and safety of Anrikefon for postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy (LC) under general anesthesia. Enrolled patients were randomly assigned to two groups (the Anrikefon group and the dizocine group) and received regular intravenous administration of the respective medication following the corresponding surgical procedure. The primary efficacy endpoint was the Quality of Recovery (QoR-15 score) at 24 hours postoperatively, combined with the Numerical Rating Scale (NRS), the Brief Pain Inventory (BPI), sleep quality (RCSQ), and postoperative recovery progress (time to first meal, first flatus, and first ambulation, etc.) for a comprehensive evaluation of efficacy; At the same time, safety indicators-including adverse events (such as nausea and vomiting, and shoulder and back pain), vital signs, and laboratory test results-were systematically monitored during the follow-up period to comprehensively evaluate the clinical utility of this protocol.
- Conditions
- Gallbladder Stones, Gallbladder Polyps
- Being tested
- Anrikefon, Dezocine
- Keywords
- Laparoscopic Cholecystectomy, Anrikefon, Postoperative Pain Management, Opioid Analgesia
- Medical subject headings
- Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnrikefonDrug
1.0 µg/kg per dose, administered by intravenous bolus injection every 8 hours at 0, 8, and 16 hours postoperatively, for a total of 3 doses. Specific preparation: Dilute 1.0 µg/kg of Anrikefon with 0.9% sodium chloride injection to a total volume of 10 mL.
DezocineDrug
5 mg/dose, IV bolus, q8h. Administered at 0h, 8h, and 16h postoperatively for a total of 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| Anrikefon Group | Experimental | * Subjects will undergo screening according to the trial flowchart. Successfully screened subjects will obtain a randomization number prior to administration and will be divided into two groups: the Anrikefon group and the Dezocine group.
* Anrikefon Group: 1.0 µg/kg per dose, administered by intravenous bolus injection every 8 hours at 0, 8, and 16 hours postoperatively, for a total of 3 doses. Specific preparation: Dilute 1.0 µg/kg of Anrikefon with 0.9% sodium chloride injection to a total volume of 10 mL. Receives: Drug: Anrikefon |
| Dezocine Group | Active comparator | * Subjects will undergo screening according to the trial flowchart. Successfully screened subjects will obtain a randomization number prior to administration and will be divided into two groups: the Anrikefon group and the Dezocine group.
* Dezocine Group: 5 mg/dose, IV bolus, q8h. Administered at 0h, 8h, and 16h postoperatively for a total of 3 doses. Receives: Drug: Dezocine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-15 (QoR-15) scale at 24 hours postoperatively.
The QoR-15 scale was used 24 hours after surgery to assess the quality of patients' postoperative recovery. The total score of the QoR-15 scale ranges from 0 to 150, with higher scores indicating a better quality of postoperative recovery.
Measured: 24 hours after surgery
Secondary outcomes (11)
Resting and movement pain Numeric Rating Scale (NRS) Area Under the Curve (AUC 0-24h) after the initial dose
Pain intensity was assessed using the 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (the most intense pain imaginable). NRS scores were recorded at multiple time points between the first postoperative administration and 24 h ± 1 h, both while the subject was at rest and when turning over, to calculate the AUC 0-24 h. A higher AUC value indicates more severe cumulative pain over 24 hours (a worse outcome).
Measured: 24 hours after surgery
Resting and movement (turning over) postoperative pain scores using the Numeric Rating Scale (NRS) at 0h, 2h, 8h, 16h, and 24h postoperatively.
Pain intensity was assessed using an 11-point Numerical Rating Scale (NRS), with scores ranging from 0 (no pain) to 10 (the most intense pain imaginable); higher scores indicate more severe pain (and a poorer prognosis). Participants' NRS scores were recorded at the following time points: within 5 minutes of the first postoperative medication administration, both at rest and while turning over; 2 hours ± 15 minutes after the first postoperative medication administration; 8 hours (within 30 minutes before the second postoperative medication administration); 16 hours (within 30 minutes before the last postoperative medication administration); and 24 hours ± 1 hour.
Measured: 24 hours after surgery
Rescue analgesic utilization: Cumulative consumption of rescue analgesia (meperidine 75 mg) at 0-12h and 0-24h after the first dose, number of rescue interventions, time to first rescue, and the percentage of subjects not requiring rescue analgesia.
Record the cumulative dose of rescue analgesics (pethidine 75 mg) administered 0-12 hours and 0-24 hours after the patient's first postoperative dose, as well as the time at which rescue analgesics were first administered.
Measured: 24 hours after surgery
Incidence of shoulder discomfort, back pain, nausea, and vomiting in each group.
During the medical interview, ask the patient whether they have experienced shoulder discomfort, back pain, nausea, or vomiting.
Measured: 24 hours after surgery
Time to first oral intake, time to first flatus/defecation, and time to first ambulation.
The medical record documents the patient's mealtimes, times of flatulence and bowel movements, and times of getting out of bed to move around.
Measured: 24 hours after surgery
Sleep quality on postoperative day 1 assessed by the Richards-Campbell Sleep Questionnaire (RCSQ).
Every morning upon waking, participants immediately used the Richards-Campbell Sleep Questionnaire (RCSQ) to review and evaluate their sleep from the previous night. The total RCSQ score is the average of its five items, with a scoring range from 0 (worst sleep) to 100 (best sleep); a higher score indicates better sleep quality (better outcome).
Measured: 24 hours after surgery
Postoperative Brief Pain Inventory (BPI) Scores
Twenty-four hours after surgery, the Brief Pain Inventory (BPI) was used to assess participants' pain intensity and the extent to which pain interfered with their daily activities over the past 24 hours. The scale ranges from 0 to 10 points (0 indicates no pain/no interference, and 10 indicates the most intense pain imaginable/complete interference). A higher score indicates more severe pain and a greater impact on daily life (i.e., a worse outcome).
Measured: 24 hours after surgery
Incidence and severity of adverse events (AEs).
Follow-up records document the occurrence and severity of adverse events in patients.
Measured: 2 weeks post-surgery
12-Lead Electrocardiogram
During the trial, 12-lead ECG examinations were performed at regular intervals to record the ECG diagnosis (normal/abnormal), ECG heart rate (beats per minute), and QT/Qtc/PR (ms).
Measured: Baseline and the 24 hours After Surgery
Cumulative use of antiemetics within 0-24 hours after the first postoperative dose in each group
Record and compare the total cumulative dose of antiemetic medications prescribed and administered to patients in each group within the first 24 hours after the initial postoperative dose.
Measured: 24 hours after surgery
Proportion of patients in each group who received antiemetics within 0-24 hours after the first postoperative dose
Calculate and compare the percentage of patients in each group who required at least one dose of rescue antiemetic medication within the first 24 hours after the initial postoperative administration.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder StonesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Guangdong Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741188
- Sponsor's protocol ID
- Anrikefon LC01
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No