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NCT Number: NCT06015165

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

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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.

Other names: 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.

Other names: 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.

Other names: Intraoperative analgesic plan

Primary outcomes

  1. the time of recovery of work and life after surgery day

    Time frame: up to 21 days

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

Secondary outcomes

  1. postoperative rest pain

    Time frame: 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

  2. postoperative defecation pain

    Time frame: 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

  3. adverse reactions

    Time frame: up to 21 days

    adverse reactions including postoperative nausea and vomiting(PONV), dizziness, respiratory depression, etc.

  4. patients' satisfaction

    Time frame: up to 21 days

    patients' satisfaction self-rating 1-10

  5. total opioid use after surgery

    Time frame: up to 21 days

    Total opioid use from postoperative period till the discontinuation of surgery-related therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Li Fang WANG, Doctor

CONTACT

[email protected]

+8615011393879

Meng Tao ZHENG, Doctor

CONTACT

[email protected]

+8613811000378

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2023
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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