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

Overview

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.

Interventions

• Drug 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.
• 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.
• Procedure 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.

Primary outcome measures

• the time of recovery of work and life after surgery day [Time frame: up to 21 days]

Secondary outcome measures (5)

• postoperative rest pain [Time frame: up to 21 days]
• postoperative defecation pain [Time frame: up to 21 days]
• adverse reactions [Time frame: up to 21 days]
• patients' satisfaction [Time frame: up to 21 days]
• total opioid use after surgery [Time frame: up to 21 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• China-Japan Friendship Hospital — Beijing
• Department of Anesthesiology — Beijing

Identifiers

NCT: NCT06015165 · ChinaJapanFHAnesth3

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗