RecruitingNot ApplicableNCT06015165

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

Sponsor

China-Japan Friendship Hospital

Enrollment

216 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

Postoperative Pain

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria3

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 Criteria8

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

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Interventions

DRUGAnalgesia 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.

DRUGAnalgesia 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.

PROCEDUREMulti-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.