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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06015165
• Other study ID #: ChinaJapanFHAnesth3
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 10, 2024
• Est. completion date: October 10, 2025

Study information

• Verified date: February 2024
• Source: China-Japan Friendship Hospital
• Contact: Li Fang WANG, Doctor
• Phone: +8615011393879
• Email: lilythewolf[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 14 days after surgery. Primary outcome is total opioid use after surgery. Secondary outcomes include 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 and the time of returning to normal life and work.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: October 10, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Multi-modal analgesia 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.
• Multi-modal analgesia 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total opioid use after surgery	Total opioid use from postoperative period till the discontinuation of surgery-related therapy.	from the end of the surgery till 14 days after surgery
Secondary	postoperative rest pain	postoperative rest pain in Numeric Rating Scales (NRS) 1-10, when 0 means painless, and 10 means the highest level of unbearable pain	followed up once a day till 14 days after surgery
Secondary	postoperative defecation pain	postoperative defecation pain in Numeric Rating Scales (NRS) 1-10, when 0 means painless, and 10 means the highest level of unbearable pain	followed up once a day till 14 days after surgery
Secondary	adverse reactions	adverse reactions including postoperative nausea and vomiting(PONV), dizziness, respiratory depression, etc.	followed up once a day till 14 days after surgery
Secondary	patients' satisfaction	patients' satisfaction self-rating 1-10	followed up once a day till 14 days after surgery