Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2022-07-01
2024-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control Group
Standard Nursing Care
Standard Nursing Care Protocol
The control group received standard perioperative nursing care in accordance with the Chinese Consensus and Clinical Guidelines for Enhanced Recovery After Surgery (2021 edition) and the Expert Consensus on Perioperative Nursing of Anorectal Diseases (2022 edition). Preoperative fasting included a 6-hour restriction on solid food and a 2-hour restriction on clear liquids. At 8:00 p.m. on the night before surgery, patients were instructed to orally ingest 500 mL of 10% glucose solution to supplement energy reserves. Fifteen minutes of structured health education was delivered preoperatively by the assigned nurse using 3D animations to explain the surgical process. Intraoperatively, an inflatable warming blanket was used to maintain the core temperature at 38°C, and all infusion fluids were pre-warmed to 37°C. For infection prophylaxis, 30 minutes before incision, patients received intravenous cefazolin (1 g for body mass index \[BMI\] \< 25 kg/m²; 2 g for BMI ≥ 25 kg/m²).
Observation Group
MDC-based Pain Management
MDC-based Pain Management
In accordance with the IASP Guidelines for Multidisciplinary Postoperative Pain Management (2023) and the Expert Consensus on Multidisciplinary Collaboration for Pain Management in China, a three-tier MDC framework was established;Surgeons were responsible for optimizing surgical procedures (e.g., using the tissue selecting technique for stapled hemorrhoidectomy) and administering a local injection of 5 mL 0.25% ropivacaine around the wound margin at the end of surgery. Anesthesiologists performed preoperative ASA physical status classification, monitored intraoperative vital signs, and configured postoperative patient-controlled analgesia (PCA) with sufentanil at 0.02 μg/kg/h.Compound Methylene Blue Nerve Block: A solution was prepared by mixing 2 mL of 1% methylene blue, 10 mL of 0.75% ropivacaine, and 8 mL of normal saline, yielding final concentrations of 0.02% methylene blue and 0.25% ropivacaine.
Interventions
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Standard Nursing Care Protocol
The control group received standard perioperative nursing care in accordance with the Chinese Consensus and Clinical Guidelines for Enhanced Recovery After Surgery (2021 edition) and the Expert Consensus on Perioperative Nursing of Anorectal Diseases (2022 edition). Preoperative fasting included a 6-hour restriction on solid food and a 2-hour restriction on clear liquids. At 8:00 p.m. on the night before surgery, patients were instructed to orally ingest 500 mL of 10% glucose solution to supplement energy reserves. Fifteen minutes of structured health education was delivered preoperatively by the assigned nurse using 3D animations to explain the surgical process. Intraoperatively, an inflatable warming blanket was used to maintain the core temperature at 38°C, and all infusion fluids were pre-warmed to 37°C. For infection prophylaxis, 30 minutes before incision, patients received intravenous cefazolin (1 g for body mass index \[BMI\] \< 25 kg/m²; 2 g for BMI ≥ 25 kg/m²).
MDC-based Pain Management
In accordance with the IASP Guidelines for Multidisciplinary Postoperative Pain Management (2023) and the Expert Consensus on Multidisciplinary Collaboration for Pain Management in China, a three-tier MDC framework was established;Surgeons were responsible for optimizing surgical procedures (e.g., using the tissue selecting technique for stapled hemorrhoidectomy) and administering a local injection of 5 mL 0.25% ropivacaine around the wound margin at the end of surgery. Anesthesiologists performed preoperative ASA physical status classification, monitored intraoperative vital signs, and configured postoperative patient-controlled analgesia (PCA) with sufentanil at 0.02 μg/kg/h.Compound Methylene Blue Nerve Block: A solution was prepared by mixing 2 mL of 1% methylene blue, 10 mL of 0.75% ropivacaine, and 8 mL of normal saline, yielding final concentrations of 0.02% methylene blue and 0.25% ropivacaine.
Eligibility Criteria
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Inclusion Criteria
* No severe anal malformations (defined as conditions that could significantly alter surgical technique or affect wound healing, such as anal stenosis or grade III or higher rectal prolapse) and no history of previous anal surgery;
* Complete clinical data available;
* Clear consciousness and intact cognitive and communication abilities, with the capacity to comply with study assessments and interventions;
* Diagnosis of a common benign anorectal disease requiring elective surgery (e.g., grade III/IV mixed hemorrhoids, simple anal fistula, chronic anal fissure, low perianal abscess) in accordance with the diagnostic criteria outlined in the Guideline for Clinical Diagnosis and Treatment of Hemorrhoids (2017 edition).
Exclusion Criteria
* History of chronic pain syndromes or long-term use of opioid analgesics;
* Presence of moderate-to-severe lumbar spinal disease or deformity that precludes neuraxial anesthesia (e.g., planned spinal anesthesia);
* Withdrawal from the study or incomplete clinical data;
* History of psychiatric disorders or cognitive impairment rendering the patient unable to comply with assessments.
18 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
Responsible Party
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Ying Zhang
Associate Chief Physician
Principal Investigators
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Ying Zhang
Role: PRINCIPAL_INVESTIGATOR
China-Japan Friendship Hospital
Locations
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China-Japan Friendship Hospita
Beijing, Beijing City, China
Countries
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Other Identifiers
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ChinaJapanFH010
Identifier Type: -
Identifier Source: org_study_id