Biased opioid medications after gynecologic laparoscopy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-center trial compares four postoperative analgesia regimens in adults undergoing elective gynecologic laparoscopic surgery. Participants receive either lower-dose tegileridine, higher-dose tegileridine, oliceridine, or sufentanil via patient-controlled intravenous analgesia after surgery. The primary outcome is time to gastrointestinal recovery, defined as the interval from the end of surgery to the first bowel movement and related criteria. The study aims to enroll 212 participants to determine if biased μ-opioid receptor agonists shorten GI recovery with potentially better tolerability. The trial is conducted at The Second Affiliated Hospital of Hainan Medical University in Haikou, China, with Hainan Medical College as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female patients aged 18 to 75 years scheduled for elective gynecologic laparoscopic surgery.
* American Society of Anesthesiologists (ASA) physical status I-III.
* Body mass index (BMI) between 18 and 30 kg/m².
* Normal preoperative liver and kidney function, with cardiopulmonary function adequate to tolerate surgery.
* Voluntary provision of written informed consent.

Exclusion Criteria:

* Inability to provide informed consent before surgery or difficulty communicating.
* Known allergy to any of the study medications.
* Severe hepatic impairment (Child-Pugh class C), severe renal impairment (creatinine clearance below 30 mL/min), or ongoing long-term dialysis.
* Severe cardiovascular or cerebrovascular disease, including myocardial infarction, cardiac arrest, decompensated heart failure, significant arrhythmias (such as second-degree or higher atrioventricular block without a pacemaker), congenital heart disease, severe valvular disease, extensive cerebral hemorrhage, or cerebral infarction; or significant respiratory disease, including a history of asthma, acute exacerbation of chronic obstructive pulmonary disease, or previous pulmonary resection.
* History of long-term opioid use before surgery or chronic pain.
* Pregnancy or breastfeeding.
* Other severe medical conditions or psychiatric disorders that make participation in the study unsuitable.

Where it's running

• The Second Affiliated Hospital of Hainan Medical University
  Haikou, Hainan, China Recruiting

Study contacts

• Study coordinator: Shuangqing Wu
• Email: 1067382988@qq.com
• Phone: 8618390551805

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.