the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery

Launched by XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Jul 28, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to see if a medication called Oliceridine fumarate injection can help manage acute pain after abdominal surgery. The researchers want to find out if this new treatment works as well as another pain medication, Sufentanil Citrate, and if it has fewer side effects. Participants in the study will receive either Oliceridine or Sufentanil after their surgery, and they'll be monitored closely for 48 hours to check how well the medication controls their pain and any side effects they may experience.

To be eligible to join the trial, participants must be between 18 and 75 years old and scheduled for specific types of abdominal surgeries. They should be able to understand the study procedures and provide consent before starting. Throughout the trial, participants can expect to manage their pain using a special device that allows them to control their medication. This study is important because it could help improve pain management for patients recovering from surgery while minimizing the risk of side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1.Preoperative inclusion criteria
• • 1. aged ≥18 years and ≤75 years at screening;
• • 2. Plan to undergo open or laparoscopic abdominal surgery, and the estimated operative time more than 2 hours.
• • 3. able to understand and comply with research procedures and requirements, and can provide a written informed consent.
• 2.postoperative inclusion criteria:
• • 1. patients who required open or laparoscopic surgery;
• • 2. According to the investigator's judgment, the patient had recovered sufficiently from the intraoperative anesthesia protocol to accurately complete the protocol-specified questionnaire;
• Exclusion Criteria:
• 1.preoperative exclusion criteria:
• • 1. ASA grade \>III
• • 2. existing other acute or chronic pain conditions;
• • 3. body mass index (BMI) \< 18 or \> 30 kg/m2;
• • 4. with sleep apnea syndrome; 5 ) long-term opioid treatment, defined as receiving more than 15mg morphine equivalent units per day on more than 3 days per week for a period of more than 1 month in the 12 months prior to surgery;
• • 6) suffering from mental or nervous system diseases (such as epilepsy, depression, schizophrenia, etc.), chronic obstructive pulmonary disease or pulmonary heart disease, heart failure, severe arrhythmia, etc; 7) with severe liver and kidney dysfunction; 8) Other conditions considered by the investigator to be inappropriate for enrollment.
• Postoperative exclusion criteria:
• • 1. intraoperative, postoperative or anesthetic deviations that may affect the efficacy and safety evaluation in the study;
• • 2. evidence of hemodynamic instability or respiratory insufficiency.