NCT07525986 Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
| NCT ID | NCT07525986 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking University First Hospital |
| Condition | Laparoscopic Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2026-04-14 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2026-04-14 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Visceral pain following laparoscopic surgery is frequently underestimated, yet it is associated with a range of adverse outcomes. Effective visceral pain management should constitute an essential component of postoperative analgesic strategies following laparoscopic procedures. However, conventional analgesic agents, including μ-opioid receptor agonists, lack specificity for visceral pain. Anrikefon, a novel selective peripheral κ-opioid receptor agonist, demonstrates unique efficacy in alleviating visceral pain with a favorable safety profile. Preliminary studies showed that a single intravenous dose of anrikefon effectively alleviates postoperative pain after abdominal surgery with a low risk of adverse effects. The investigators hypothesize that an appropriate dosing regimen of anrikefon administered via patient-controlled intravenous analgesia (PCIA) pump, as part of a multimodal analgesic strategy, can specifically target and alleviate visceral pain after laparoscopic surgery, thereby achieving comprehensive postoperative analgesia.
Eligibility Criteria
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.
Contact & Investigator
Dong-Xin Wang, MD, PhD
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT07525986 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Laparoscopic Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07525986 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07525986 currently recruiting?
Yes, NCT07525986 is actively recruiting participants. Contact the research team at wangdongxin@hotmail.com for enrollment information.
Where is the NCT07525986 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07525986 clinical trial?
NCT07525986 is sponsored by Peking University First Hospital. The principal investigator is Dong-Xin Wang, MD, PhD at Peking University First Hospital. The trial plans to enroll 140 participants.