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Efficacy of anrikefon-based patient-controlled intravenous analgesia for pain management after laparoscopic surgery: a randomized, double-blind, active-controlled pilot trial

Efficacy of anrikefon-based patient-controlled intravenous analgesia for pain management after laparoscopic surgery: a randomized, double-blind, active-controlled pilot trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112103
Enrollment
Unknown
Registered
2025-11-10
Start date
2025-11-21
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain after laparoscopic surgery.

Interventions

Medium-dose anrikefon group:Medium-dose anrikefon-based patient-controlled analgesia
Morphine group:Morphine-based patient-controlled analgesia
High-dose anrikefon group:High-dose anrikefon-based patient-controlled analgesia
Low-dose anrikefon group:Low-dose anrikefon-based patient-controlled analgesia

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1.Aged = 18 years but < 75 years; 2.Scheduled to undergo elective laparoscopic gastrointestinal 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

Exclusion criteria: 1.Presence of preoperative cognitive impairment (Mini-Mental State Examination [MMSE] score 30 kg/m² or 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 = 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;

Design outcomes

Primary

MeasureTime frame
Time-weighted sum of pain intensity difference (SPID) of movement-evoked visceral pain within 48 hours;

Secondary

MeasureTime frame
Time-weighted SPID of overall pain with movement or at rest within 48 hours;Time-weighted SPID of somatic pain with movement or at rest within 48 hours;Time-weighted SPID of visceral pain at rest within 48 hours;

Countries

China

Contacts

Public ContactDong-Xin Wang

Peking University First Hospital

wangdongxin@hotmail.com+86 10 83572784

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026