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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-10

Study Completion Date

2025-10-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open label trial.

Study Groups

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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.

Group Type EXPERIMENTAL

Analgesia plan for Anes. Group

Intervention Type 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.

Multi-modal analgesia during the surgery

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Analgesia plan for Surg. Group

Intervention Type 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.

Multi-modal analgesia during the surgery

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Other Intervention Names

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Anes Group Surg. Group Intraoperative analgesic plan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No