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

Not Applicable

Recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: Analgesia plan for Anes. Group; Drug: Analgesia plan for Surg. Group; Procedure: Multi-modal analgesia during the surgery

• Registration Number: NCT06015165
• Lead Sponsor: China-Japan Friendship Hospital

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.

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 surgery under short and complex general anesthesia. However, the implementation of perioperative analgesia in anorectal surgery has not been paid enough attention. This study aims to establish the application of anesthesiologist-led multidisciplinary postoperative analgesia in anorectal surgery under general anesthesia.

Objectives: Patients undergoing complex anorectal surgery under general anesthesia will be randomly divided into two groups: anesthesiologist-led group (Anes Group) and surgeon-led group (Surg Group).

Interventions: Both groups will receive general anesthesia combined with long-term local anesthesia, postoperative patient controlled intravenous analgesia (PCIA) and multi-mode analgesia including laxatives and antibiotics. In Anes Group, patients receive postoperative analgesia following the protocol established by the anesthesiologist, continuous with intraoperative analgesic protocol. In Surg Group, patients will be given postoperative analgesia and follow-ups by the traditional mode formulated by the surgeons and the consultant of the pharmacists. The postoperative PCIA analgesic formula and the choice of analgesics are same in the two groups.

Follow-ups and outcomes: Patients will be followed-up till total recovery after surgery. Primary outcome is the time of recovery of work and life after surgery day, defined as not requiring any additional medication and resuming full pre-operative work life content. Secondary outcomes include opioid use after surgery, the degree of pain during defecation and rest pain, the adverse reactions related to analgesia, satisfaction, the time of ambulation, the length of hospital stay.

The purpose of this study was to evaluate the feasibility of anesthesiologist-led care model in complex anorectal surgery and to optimize the perioperative analgesia in anorectal surgery.

Study Timeline

• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-27
• Study First Posted: 2023-08-29
• Study Start: 2024-09-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2025-06-30
• Study Completion: 2025-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anes Group	Analgesia plan for Anes. Group	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.
Anes Group	Multi-modal analgesia during the surgery	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.
Surg. group	Analgesia plan for Surg. Group	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.
Surg. group	Multi-modal analgesia during the surgery	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.

Primary Outcome Measures

Name	Time	Method
the time of recovery of work and life after surgery day	up to 21 days	not requiring any additional medication and resuming full pre-operative work life content

Secondary Outcome Measures

Name	Time	Method
postoperative rest pain	up to 21 days	postoperative rest pain in Numeric Rating Scales (NRS) 1-10, when 0 means painless, and 10 means the highest level of unbearable pain
postoperative defecation pain	up to 21 days	postoperative defecation pain in Numeric Rating Scales (NRS) 1-10, when 0 means painless, and 10 means the highest level of unbearable pain
adverse reactions	up to 21 days	adverse reactions including postoperative nausea and vomiting(PONV), dizziness, respiratory depression, etc.
patients' satisfaction	up to 21 days	patients' satisfaction self-rating 1-10
total opioid use after surgery	up to 21 days	Total opioid use from postoperative period till the discontinuation of surgery-related therapy.

Trial Locations

Locations (2)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Department of Anesthesiology; 🇨🇳 Beijing, Beijing, China