Gallbladder Removal Clinical Trials

Clinical trials related to Gallbladder Removal Procedure

Effect of Preventive Analgesia With Anrikefon on Postoperative Acute Pain and Rehabilitation Process in Adult Patients Undergoing Laparoscopic Cholecystectomy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• ASA physical status classification I-III;

• Age 18-65 years;

• Scheduled for elective laparoscopic cholecystectomy;

• Voluntary signed informed consent;

• BMI between 18-28 kg/m²;

• No history of general anesthesia surgery within the past 3 months.

Locations
Other Locations
China
Xuanwu Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Wei Xiao, PhD
kitten15@126.com
+8613810971299
Time Frame
Start Date: 2026-06-02
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 274
Treatments
Experimental: Preventive Analgesia Group
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.
Active_comparator: Bridging Analgesia Group
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.
Sponsors
Collaborators: Haisco Pharmaceutical Group Co., Ltd.
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov

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