Anesthesiologist-led pain management for anorectal surgery
Outcomes for Anesthesiologist-Led Care of Analgesic Protocol in Anorectal Surgery
NA · China-Japan Friendship Hospital · NCT06015165
This study tests whether having an anesthesiologist manage pain after complex anorectal surgery helps patients feel better and more satisfied compared to having the surgeon handle pain management.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital (other) |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06015165 on ClinicalTrials.gov |
What this trial studies
This open, prospective, parallel-group, randomized controlled trial aims to evaluate the effectiveness and safety of anesthesiologist-led postoperative analgesia compared to surgeon-led analgesia in patients undergoing complex anorectal surgery under general anesthesia. Patients will be randomly assigned to either the anesthesiologist-led group or the surgeon-led group, both receiving general anesthesia and multi-modal analgesia. The study will assess pain management outcomes, quality of life, and patient satisfaction over a follow-up period after surgery. The goal is to establish a more effective analgesia protocol for managing postoperative pain in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for complex anorectal surgery under general anesthesia with ASA grading I-III.
Not a fit: Patients with a history of severe asthma, opioid abuse, or significant liver or renal dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and patient satisfaction after anorectal surgery.
How similar studies have performed: Other studies have shown promising results with anesthesiologist-led analgesia approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. American Society of Anesthesia (ASA) grading I-III 2. ≥18 years old 3. Patients scheduled for complex anorectal surgery under general anesthesia, e.g., mixed hemorrhoidectomy/sclerosing agent injection/ligation, radical anal fistula resection, peri-anal abscess incision and drainage Exclusion Criteria: 1. Informed consent not obtained 2. Allergic to general anesthetics, hydromorphone, non-steroidal anti-inflammatory drugs and other related ingredients 3. Opioid abuse or pathological pain that requires long-term analgesic treatment 4. History of severe asthma attack and acute phase of asthma 5. Moderate or above ventilatory function or diffusion dysfunction 6. Liver dysfunction reached Child B grade; Renal insufficiency reached chronic kidney disease (CKD) stage IV 7. Gastric retention and paralytic ileus 8. Pregnant and lactating patients
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (RECRUITING)
- Department of Anesthesiology — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Li Fang WANG, Doctor
- Email: lilythewolf@sina.com
- Phone: +8615011393879
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.
Conditions: Postoperative Pain, ambulatory surgery, anorectal surgery, postoperative analgesia, anesthesiologist-led care