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

NCT06015165 | Recruiting DMC

• 1 other identifier: ChinaJapanFHAnesth3
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Postoperative Pain

Keywords

ambulatory surgery; anorectal surgery; postoperative analgesia; anesthesiologist-led care

Outcome Measures

Primary Outcomes (1)

• the time of recovery of work and life after surgery day

  not requiring any additional medication and resuming full pre-operative work life content

  up to 21 days

Secondary Outcomes (5)

• postoperative rest pain

  up to 21 days

• postoperative defecation pain

  up to 21 days

• adverse reactions

  up to 21 days

• patients' satisfaction

  up to 21 days

• total opioid use after surgery

  up to 21 days

Study Arms (2)

Anes Group

EXPERIMENTAL

In Anes Group, the anesthesiologist routinely works in the operating room, and will communicate with anorectal physicians through bedside visits, video telephone calls, and a hospital-wide electronic medical record system in the operating room. Anesthesiologists will evaluate the patient's pain degree and symptoms perioperatively at bedside, and will administer opioids or non-opioids at the optimal interval and standard dose until discharge. The anesthesiologist and the surgeon will jointly formulate the discharge medication plan and give the patient guidance on analgesic treatment.

Drug: Analgesia plan for Anes. Group; Procedure: Multi-modal analgesia during the surgery

Surg. group

ACTIVE COMPARATOR

According to the current perioperative management mode, patients in the surgeon-led group (Surg. group) will be given local anesthesia during the operation, and will receive routine ambulatory surgery anesthesia plan, and routine postoperative analgesia plan in the ward will be given to the patients, under the guidance of the department of pharmacy. The patients will receive rescue opioids and standardized NSAIDs until discharge.

Drug: Analgesia plan for Surg. Group; Procedure: Multi-modal analgesia during the surgery

Interventions

Analgesia plan for Anes. Group DRUG

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.

Also known as: Anes Group

Anes Group

Analgesia plan for Surg. Group DRUG

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.

Also known as: Surg. Group

Surg. group

Multi-modal analgesia during the surgery PROCEDURE

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.

Also known as: Intraoperative analgesic plan

Anes Group; Surg. group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (2)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Department of Anesthesiology

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Wei Xia Li, Doctor

  China-Japan Friendship Hospital

  STUDY DIRECTOR

Central Study Contacts

Li Fang WANG, Doctor

CONTACT

+8615011393879; lilythewolf@sina.com

Meng Tao ZHENG, Doctor

CONTACT

+8613811000378; dragon0303@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open label trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending doctor

Model Details: Patients undergoing complex anorectal surgery under general anesthesia will be included in this study. In Anes Group, the anesthesiologist routinely works in the operating room, and will communicate with anorectal physicians through bedside visits, video telephone calls, and a hospital-wide electronic medical record system in the operating room. Anesthesiologists will administer opioids or non-opioids at the optimal interval and standard dose until discharge. The anesthesiologist and the surgeon will jointly formulate the discharge medication plan and give the patient guidance on analgesic treatment. Patients in the Surg. Group will be given local anesthesia during the operation, and will receive routine ambulatory surgery anesthesia plan, and routine postoperative analgesia plan in the ward will be given to the patients, under the guidance of the department of pharmacy. The patients will receive rescue opioids and standardized NSAIDs until discharge.

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 29, 2023
• Study Start: September 10, 2024
• Primary Completion: June 30, 2025
• Study Completion: October 10, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)