Total Laparoscopic Hysterectomy
Conditions
Keywords
Tegileridine, Postoperative pain, Total Laparoscopic Hysterectomy, Oxycodone
Brief summary
This randomized, double-blind, controlled study aims to evaluate the efficacy and safety of Tegileridine or Oxycodone for postoperative analgesia in patients undergoing Total Laparoscopic Hysterectomy（TLH）. Subjects will be randomly assigned to receive an equivalent dose of intravenous Tegileridine or Oxycodone as part of a standard postoperative analgesia regimen. All patients will have access to rescue opioid analgesia according to the protocol. The primary outcome measures are the incidence of postoperative nausea and vomiting in two groups receiving a single dose of equivalent morphine analgesics (Group Tegileridine or Group Oxycodone).The secondary endpoints were designed to compare the success rate of postoperative analgesia, cumulative opioid consumption within 48 hours postoperatively, the time to first rescue analgesia, and the incidence of adverse events such as sedation, respiratory depression, pruritus, and constipation. Safety will be monitored throughout the study via predefined stop-and-report procedures. The study results will evaluate whether teglitazide provides a more effective, better-tolerated analgesic regimen for patients undergoing total laparoscopic hysterectomy.
Interventions
Tegileridine (tegileridine fumarate injection, IV) is a small-molecule μ-opioid receptor agonist with G-protein-biased signaling (relative to β-arrestin-2 recruitment), developed by Jiangsu Hengrui for postoperative analgesia. It is administered intravenously and was first approved in China in January 2024 for the treatment of moderate-to-severe pain after abdominal surgery; in this study, tegileridine is used as part of standardized multimodal analgesia according to protocol. In China it is regulated as a narcotic drug.
DRUGOxycodone（Oxycodone Hydrochloride Injection，IV）
Oxycodone bitartrate is a dual opioid receptor agonist that is used in clinical settings. Oxycodone bitartrate injection is indicated for the relief of moderate to severe cancer pain. It can be administered alone or in combination with non-steroidal anti-inflammatory drugs to provide acute combined analgesia. In January 2021, Jiangsu Enhua Pharmaceutical submitted a marketing authorisation application for Oxycodone bitartrate injection to the National Medical Products Administration.The application has been accepted and approved.
Sponsors
Xin Chen
Second Affiliated Hospital of Hainan Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing laparoscopic total abdominal hysterectomy with single-lumen endotracheal tube placement under general anaesthesia. 2. Females aged 18-65 years with a BMI of 18-28 kg/m²; 3. Normal mouth opening and head/neck mobility; 4. Preoperative American Society of Anesthesiologists (ASA) physical status classification of I-III and Mallampati airway classification of I or II; 5. Patients must also be scheduled for postoperative analgesia and have signed an informed consent form.
Exclusion criteria
1. Patients with allergies to the medications used in this study. 2. Patients with severe diseases of major organs, such as the heart, lungs or brain, including a history of acute myocardial infarction, cerebral infarction, asthma or chronic obstructive pulmonary disease; 3. Patients with severe liver or kidney dysfunction, or concomitant severe endocrine disorders such as poorly controlled hypertension, diabetes, hyperthyroidism or hypothyroidism. 4. Patients with a difficult airway, oropharyngeal/cervical anomalies, or a history of prior tracheostomy; 5. A history of prolonged sedative/analgesic use, substance abuse or opioid dependence; 6. Patients with neuropsychiatric disorders or impaired communication/comprehension abilities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The occurrence of postoperative nausea and vomiting | Within 48 hours after surgery | Following surgery, a blinded evaluator assessed PONV using a 4-point ordinal scale (0 = none, 1 = nausea, 2 = retching, 3 = vomiting). Nausea was defined as a subjectively unpleasant sensation associated with awareness of the urge to vomit. Retching was defined as labored, spasmodic, rhythmic contraction of the respiratory muscles without expulsion of gastric contents. Vomiting was defined as the forceful expulsion of gastric contents from the mouth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of First Pressing of the PCIA | Within 48 hours after surgery | Time of First Postoperative Pressing of the Patient-Controlled Intravenous Analgesia（PCIA） pump |
| Overall incidence of adverse reactions | Within 48 hours after surgery | Incidence of Postoperative nausea and vomiting, hypotension, nasal congestion, dizziness, respiratory depression, delayed emergence from anesthesia, pruritus, muscle rigidity, convulsions, constipation, urinary retention, agitation during emergence, and convulsions. |
| Richmond Agitation and Sedation Scale(RASS) | Immediately before removal of the endotracheal tube (Postoperative Day 0). | The research team assigns a RASS score (minimum -5 = unarousable, maximum +4 = combative; scores closer to 0 indicate an alert and calm state) by observing the patient immediately before tracheal extubation. |
| Success rate of postoperative pain management | After the surgery, before leaving the recovery room（Day 0） | Following extubation during anaesthesia recovery after surgery, pain intensity was assessed at rest using a 10-cm visual analogue scale (VAS) by a blinded evaluator (with a minimum score of 0 indicating no pain and a maximum score of 10 indicating the most severe pain imaginable). Analgesia was recorded as successful when the VAS score was ≤3; otherwise, it was considered unsuccessful. |
Countries
China
Outcome results
None listed