Preventive Analgesia With Anrikefon in Laparoscopic Cholecystectomy
ConditionPostoperative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ASA physical status classification I-III;
Age 18-65 years;
Scheduled for elective laparoscopic cholecystectomy;
Voluntary signed informed consent;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Anrikefon for Preventive Analgesia
DrugThe 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 analgesia
DrugThe 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.
Treatment groups
274 Participants
are divided into 2 treatment groupsGroup A: Preventive Analgesia GroupExperimental treatment 1 intervention
Group B: Bridging Analgesia GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
From the end of surgery to 24 hours postoperativelySecondary outcomes
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.
Time frame
From the end of surgery to 24 hours postoperatively2
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.
Time frame
From the end of surgery to 24 hours postoperatively3
Duration of postoperative incisional pain and visceral pain
The duration from surgery completion to the timepointing when NRS score is\< 3 .
Time frame
From the end of surgery to 72 hours postoperatively4
Total Oxycodone consumption of the postoperative analgesia pump
The consumption of Oxycodone in the patient-controlled analgesia (PCA) pump will be recorded.
Time frame
From the end of surgery to 48 hours postoperativelyOther outcomes
1
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
Time frame
1 day before surgery and 24 hours after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Xuanwu Hospital, Beijing
Lead sponsor
Haisco Pharmaceutical Group Co., Ltd.
Collaborator
Source ClinicalTrials.gov