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| Name | Class |
|---|---|
| Haisco Pharmaceutical Group Co., Ltd. | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the levels of IL-6, CRP, and PGE2 | 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 | 1 day before surgery and 24 hours after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Xiao, PhD | Contact | +8613810971299 | kitten15@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Xiao | Xuanwu Hospital, Beijing | Principal Investigator |
| Tianlong Wang | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059265 | Visceral Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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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.
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| 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. |
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| From the end of surgery to 24 hours postoperatively |
| 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. | From the end of surgery to 24 hours postoperatively |
| Duration of postoperative incisional pain and visceral pain | The duration from surgery completion to the timepointing when NRS score is< 3 . | From the end of surgery to 72 hours postoperatively |
| Total Oxycodone consumption of the postoperative analgesia pump | The consumption of Oxycodone in the patient-controlled analgesia (PCA) pump will be recorded. | From the end of surgery to 48 hours postoperatively |
| 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. | From the end of surgery to 72 hours postoperatively |
| 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. | at Day 1 and Day 3 after surgery |
| Recovery of gastrointestinal function | The duration from end of surgery to first flatus and first oral intake . | From the end of surgery to Day 3 after surgery |
| 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. | 24 hours, 48 hours, and 72 hours after surgery |
| 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. | From the day of hospital admission to the day of discharge, on anverage of 3-5 days. |
| 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. | From anesthesia induction to 72 hours after surgery |
| 30 days mortality | any death of patients occur in 30 days after surgery | from the end of surgery to 30 days after surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D059226 | Nociceptive Pain |