Status:
RECRUITING
Outcomes for Anesthesiologist-Led Care of Analgesic Protocol in Anorectal Surgery
Lead Sponsor:
China-Japan Friendship Hospital
Conditions:
Postoperative Pain
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This will be an open, prospective, parallel-group, randomized controlled trial. Patients scheduled for complex anorectal surgery under general anesthesia will be enrolled, and the perioperative analge...
Detailed Description
Patients suffer from moderate to severe postoperative pain up to 14 days after anorectal surgery. To establish an anesthesiologist-led multidisciplinary team for postoperative analgesia in anorectal s...
Eligibility Criteria
Inclusion
- American Society of Anesthesia (ASA) grading I-III
- ≥18 years old
- 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
- Informed consent not obtained
- Allergic to general anesthetics, hydromorphone, non-steroidal anti-inflammatory drugs and other related ingredients
- Opioid abuse or pathological pain that requires long-term analgesic treatment
- History of severe asthma attack and acute phase of asthma
- Moderate or above ventilatory function or diffusion dysfunction
- Liver dysfunction reached Child B grade; Renal insufficiency reached chronic kidney disease (CKD) stage IV
- Gastric retention and paralytic ileus
- Pregnant and lactating patients
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2025
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT06015165
Start Date
September 10 2024
End Date
October 10 2025
Last Update
November 13 2024
Active Locations (2)
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1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
2
Department of Anesthesiology
Beijing, Beijing Municipality, China, 100029