Postoperative Pain
Conditions
Keywords
Preventive Analgesia, Laparoscopic Cholecystectomy, Postoperative Acute Pain, Visceral Pain, Anrikefon
Brief 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%. 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.
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).
Interventions
DRUGAnrikefon for Preventive Analgesia
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.
DRUGAnrikefon for bridging analgesia
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.
Sponsors
Xuanwu Hospital, Beijing
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. ASA physical status classification I-III; 2. Age 18-65 years; 3. Scheduled for elective laparoscopic cholecystectomy; 4. Voluntary signed informed consent; 5. BMI between 18-28 kg/m²; 6. No history of general anesthesia surgery within the past 3 months.
Exclusion criteria
1. Severe cardiovascular disease, respiratory disease, or psychiatric disorders; 2. Severe renal insufficiency; 3. Recent use of diuretics or compound medications containing diuretics; 4. Continuous use of opioid analgesics for more than 10 days within the past 3 months; 5. Use of medications with unknown half-life affecting analgesic efficacy within 14 days prior to randomization; 6. Pregnant women, lactating women, or those planning pregnancy in the near future; 7. History of hypersensitivity to study medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time-weighted sum of pain intensity differences over 0-24 hours postoperatively of visceral pain | 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
| Measure | Time frame | Description |
|---|---|---|
| The time-weighted sum of pain intensity differences over 0-24 hours postoperatively of Incisional pain | 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. |
| The Numerical Rating Scale scores for visceral pain and incisional pain | 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. |
| Duration of postoperative incisional pain and visceral pain | From the end of surgery to 72 hours postoperatively | The duration from surgery completion to the timepointing when NRS score is\< 3 . |
| Total Oxycodone consumption of the postoperative analgesia pump | From the end of surgery to 48 hours postoperatively | The consumption of Oxycodone in the patient-controlled analgesia (PCA) pump will be recorded. |
| Total Parecoxib sodium for rescue analgesia after surgery | 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. |
| 15-item Quality of Recovery scale | 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. |
| Recovery of gastrointestinal function | From the end of surgery to Day 3 after surgery | The duration from end of surgery to first flatus and first oral intake . |
| Intake, Feeling nauseated, Emesis, Exam, and Duration of symptoms scoring system score | 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. |
| Length of hospital stay | 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. |
| Rate of adverse reactions and complications | 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. |
| 30 days mortality | from the end of surgery to 30 days after surgery | any death of patients occur in 30 days after surgery |
Countries
China
Contacts
CONTACTWei Xiao, PhD
PRINCIPAL_INVESTIGATORWei Xiao
Xuanwu Hospital, Beijing
PRINCIPAL_INVESTIGATORTianlong Wang
Xuanwu Hospital, Beijing
Outcome results
None listed