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RECRUITING
NCT06015165
NA

Outcomes for Anesthesiologist-Led Care of Analgesic Protocol in Anorectal Surgery

Sponsor: China-Japan Friendship Hospital

View on ClinicalTrials.gov

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 analgesia mode led by anesthesiologists will be established. Compared with the perioperative analgesia mode led by surgeons, the efficacy and safety of analgesia, quality of life and satisfaction of patients will be evaluated. This study is aimed at the feasibility and efficiacy of anesthesiologist-led treatment mode in the management of moderate and severe pain in patients after complex anorectal surgery.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2024-09-10

Completion Date

2025-10-10

Last Updated

2024-11-13

Healthy Volunteers

No

Interventions

DRUG

Analgesia plan for Anes. Group

For Anes. Group, hydromorphone intravenous pump (PCIA) with 0.04mg/hr and 0.2mg/hr bolus controlled administration. Rescue opioids will be given as sufentanil 5μg/hr, depending on the time of the last intraoperative administration. NSAIDs such as flurbiprofen axetil or ibuprofen will be administered as a complementary treatment option.

DRUG

Analgesia plan for Surg. Group

For Surg. Group, hydromorphone intravenous pump is set with the same analgesic formula as in Anes. Group. Routine prescriptions for rescue opioids (tramadol) and NSAIDs according to pain level recommended by the pharmacy department will be administered.

PROCEDURE

Multi-modal analgesia during the surgery

Multi-modal analgesia, including intraoperative long-acting local anesthetics (ropivacaine and methylene blue), perioperative narcotic analgesics, and postoperative laxative and antibiotics. PCIA with the same analgesic formula will be applied in both groups.

Locations (2)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Department of Anesthesiology

Beijing, Beijing Municipality, China