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Trials / Withdrawn

WithdrawnNCT07150819

A Multidisciplinary Perioperative Pain Management

Effectiveness of a Multidisciplinary Perioperative Pain Management Model in Enhancing Recovery After Anorectal Surgery

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
China-Japan Friendship Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Objective: This study aimed to evaluate the clinical value of a multidisciplinary collaboration (MDC)-based perioperative pain management model. Methods: A prospective, randomized controlled trial was conducted involving 126 patients who underwent anorectal surgery between July 2022 and December 2023. Participants were randomly assigned (1:1) using a computer-generated sequence to either the control group (n = 63), which received standard nursing care, or the observation group (n = 63), which received nursing care based on the MDC model integrating surgery, anesthesiology, nursing, psychology, and pharmacy disciplines.

Conditions

Interventions

TypeNameDescription
BEHAVIORALStandard Nursing Care ProtocolThe 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).
BEHAVIORALMDC-based Pain ManagementIn 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.

Timeline

Start date
2022-07-01
Primary completion
2023-12-30
Completion
2024-12-10
First posted
2025-09-02
Last updated
2025-12-19

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07150819. Inclusion in this directory is not an endorsement.

A Multidisciplinary Perioperative Pain Management (NCT07150819) · Clinical Trials Directory