Anricfen for pain relief and recovery after pancreaticoduodenectomy
The Safety and Efficacy of Aniracetamfen for Postoperative Analgesia and Rehabilitation After Pancreaticoduodenectomy: A Single-center, Single-arm Clinical Study
This will try a short course of IV Anricfen in adults after pancreaticoduodenectomy to see if it reduces pain and speeds recovery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing) |
| Trial ID | NCT07514637 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives adults who undergo pancreaticoduodenectomy intravenous Anricfen at 1 μg/kg every 8 hours for three days after surgery. Pain scores, opioid consumption, and measures of recovery such as time to ambulation, return of bowel function, and length of stay will be recorded as primary and secondary outcomes. Blood and tissue samples will be collected for exploratory biomarker analyses and correlated with tumor pathology. The single-center trial is conducted at The Affiliated Nanjing Drum Tower Hospital and enrolls patients aged 18–79 with ASA I–III who can provide informed consent.
Who should consider this trial
Good fit: Adults 18–79 undergoing pancreaticoduodenectomy (including PD, PPPD, or LPD), with ASA I–III and the ability to give informed consent and tolerate postoperative IV treatment are ideal candidates.
Not a fit: Patients with severe cardiac, cerebral, hepatic, renal, or hematopoietic disease, pregnancy or lactation, chronic preoperative pain with long-term analgesic use, substance abuse, thyroid dysfunction, or known allergy to the medication are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, Anricfen could reduce postoperative pain, lower opioid needs, and help patients recover faster after pancreaticoduodenectomy.
How similar studies have performed: Peripheral kappa opioid receptor agonists have shown analgesic effects in preclinical work and early-phase human trials, but perioperative use after pancreaticoduodenectomy is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who underwent pancreatic surgery, including pancreaticoduodenectomy (PD), pancreatic-preserving pancreaticoduodenectomy (PPPD), and laparoscopic pancreaticoduodenectomy (LPD) * Age ≥ 18 years old and \< 80 years old * ASA Ⅰ-Ⅲ * Be able to clearly understand and voluntarily participate in the research Exclusion Criteria: * Merging severe primary diseases involving the heart, brain, liver, kidneys and hematopoietic system * History of long-term use of psychotropic drugs and cognitive dysfunction * Having a history of acute poisoning from alcohol, sleeping pills, painkillers or other drugs that affect the central nervous system * Pregnancy or lactation period * History of allergy to NSAIDs, opioids, or to the test medication * Drug users, alcoholics, and opiate abusers * Those who had a history of chronic pain before the operation and a history of long-term use of analgesics and/or sedatives * Those who had thyroid dysfunction before the operation
Where this trial is running
Nanjing
- NanJing drum tower hospital — Nanjing, China (Recruiting)
Study contacts
- Study coordinator: yudong QIU
- Email: yudongqiu510@163.com
- Phone: 0086+13809021967
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.