Patient-controlled IV anrikefon for pain after laparoscopic colorectal surgery

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

In this Phase 4 interventional study, adults undergoing elective laparoscopic colorectal surgery who receive a transversus abdominis plane or rectus sheath block will be given patient-controlled intravenous analgesia (PCIA) delivering low, medium, or high doses of anrikefon or morphine. Participants will use the PCIA pump for postoperative pain control and investigators will record pain intensity, opioid consumption, adverse events, and recovery measures during the early postoperative period. Anrikefon is a selective peripheral κ-opioid receptor agonist thought to preferentially relieve visceral pain with fewer central opioid side effects. The study aims to identify an effective PCIA dosing regimen for anrikefon as part of a multimodal analgesic strategy after laparoscopic procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged \>= 18 years but \< 75 years;
2. Scheduled to undergo elective laparoscopic colorectal surgery with an expected duration of \>=1 hour;
3. The incisional pain can be covered by the transversus abdominis plane block or rectus sheath block; yet patients still require postoperative patient-controlled intravenous analgesia.

Exclusion Criteria:

1. Presence of preoperative cognitive impairment (Mini-Mental State Examination \[MMSE\] score \< 27), or inability to communicate due to language barrier;
2. Body mass index (BMI) \> 30 kg/m² or \< 18 kg/m²;
3. Presence of poorly controlled or untreated comorbidities, including but not limited to the following: hypertension characterized by a resting systolic blood pressure (SBP) \> 180 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg, coronary artery disease with unstable angina or myocardial infarction within 6 months, heart failure rated as New York Heart Association classification \>= III, severe chronic obstructive pulmonary disease (or in a state of acute exacerbation), severe hepatic insufficiency (Child-Pugh grade C), severe renal insufficiency (estimated glomerular filtration rate \< 30 ml/min/1.73m²), or American Society of Anesthesiologists (ASA) physical status classification \>= IV;
4. Continuous use of opioid analgesics for more than 10 days for any reason, or alcohol abuse (average daily intake of pure alcohol \> 36 g) within 3 months before screening;
5. Preoperative use of opioid or non-opioid analgesics with the interval between the last administration and randomization shorter than five half-lives of the drug or the duration of drug action (whichever is longer);
6. Known allergies or contraindications to opiates or other medications that may be used in this study, such as anesthetics, antiemetics, and nonsteroidal anti-inflammatory drugs (NSAIDs);
7. Anticipated need for postoperative mechanical ventilation；
8. Other conditions that are considered unsuitable for study participation.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Friendship Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Not yet recruiting
• The Eighth Affiliated Hospital, Sun Yat-sen University
  Shenzhen, Guangdong, China Not yet recruiting
• Hunan Provincial People's Hospital
  Changsha, Hunan, China Not yet recruiting

Study contacts

• Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
• Study coordinator: Dong-Xin Wang, MD, PhD
• Email: wangdongxin@hotmail.com
• Phone: 8610 83572784

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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.