The goal of this clinical trial is to learn if Oliceridine fumarate injection works to treat acute pain after abdominal surgery. It will also learn about the safety of Oliceridine fumarate injection. The main questions it aims to answer are:
1. Does Oliceridine fumarate injection works to treat acute pain after abdominal surgery? 2. Does Oliceridine fumarate injection lead to less adverse effect?
Researchers will compare Oliceridine fumarate injection to a positive-drug (Sufentanil Citrate) to see if Oliceridine fumarate injection not inferior to sufentanil in the efficacy and safety for acute pain after abdominal surgery.
Participants will:
1. Receive patient controlled analgesia treat using Oliceridine or sufentanil after surgery 2. Be followed up every 6 hours until 48 hours after surgery or before discharge
aged ≥18 years and ≤75 years at screening;
Plan to undergo open or laparoscopic abdominal surgery, and the estimated operative time more than 2 hours.
able to understand and comply with research procedures and requirements, and can provide a written informed consent.
patients who required open or laparoscopic surgery;
ASA grade >III
existing other acute or chronic pain conditions;
body mass index (BMI) < 18 or > 30 kg/m2;
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;
Xiangya Hospital of Central South University
Lead sponsor
Wu Jieping Medical Foundation
Collaborator