A Multidisciplinary Perioperative Pain Management

NCT07150819 | Withdrawn

• 1 other identifier: ChinaJapanFH010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Pain Management; Anorectal Surgery

Outcome Measures

Primary Outcomes (5)

• Short-Form McGill Pain Questionnaire (SF-MPQ)

  The SF-MPQ includes two core components: the pain rating index (PRI) and present pain intensity (PPI). The PRI assesses the qualitative aspects of pain using 11 sensory descriptors (e.g., stabbing, throbbing) and 4 affective descriptors (e.g., fearful, exhausting), with a total score ranging from 0 to 45. The PPI is a single-item, 6-point scale (0 = no pain, 5 = excruciating pain).

  4 hours

• Dynamic Pain Intensity Monitoring

  The VAS \[27\] was used to assess pain intensity at five postoperative time points: immediately after surgery (T0), and at 4 hours (T1), 12 hours (T2), 24 hours (T3), and 48 hours (T4) postoperatively. The VAS consists of a 10 cm horizontal line anchored by "no pain" at 0 cm and "worst possible pain" at 10 cm; patients were asked to mark the point that best reflected their current pain level. The mark was then converted into a numeric score ranging from 0 to 10. Pain intensity was categorized as follows: 1-3 (mild, does not interfere with daily activities), 4-6 (moderate, interferes with sleep), and 7-10 (severe, completely disabling). The scale demonstrated strong internal consistency (ICC = 0.89, P \< 0.001) and high concurrent validity with the Numerical Rating Scale (r = 0.94)

  4 hours

• Postoperative Recovery Indicators

  Four objective time-based recovery parameters were recorded: (1) Time to first defecation, defined as the number of hours from anesthesia recovery to the first spontaneous bowel movement; (2) Time to first ambulation, defined as the time postoperatively at which the patient could independently stand and walk for ≥5 minutes; (3) Wound healing time, defined as the number of days required for complete epithelialization and absence of exudate, as confirmed by blinded assessment by the attending physician; (4) Length of postoperative hospital stay, measured in calendar days from the end of surgery to the date of discharge documentation.

  4 hours

• Postoperative Complication Monitoring

  Postoperative complications within 30 days were identified and recorded based on internationally accepted diagnostic criteria: (1) Urinary retention, defined as a bladder volume \>400 mL on ultrasound requiring catheterization (per the International Continence Society standard); (2) Perianal edema, defined as a palpable perianal bulge ≥1 cm in diameter with tenderness, confirmed via blinded physician assessment; (3) Wound infection, meeting criteria established by the Centers for Disease Control and Prevention (erythema, swelling, warmth, pain, and purulent discharge or white blood cell count \>10×10⁹/L); (4) Constipation, defined as no defecation within 72 hours postoperatively requiring pharmacological intervention (Rome IV criteria); (5) Anal distension, characterized by persistent anal pressure or fullness with a VAS score ≥4 sustained for more than 24 hours.

  1 Day

• Psychological Status Assessment

  The DASS-21 \[30\] was used to evaluate psychological well-being, comprising three subscales: depression (7 items), anxiety (7 items), and stress (7 items). Each item is rated on a 4-point Likert scale from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time"). Assessments were conducted at two time points: 24 hours preoperatively (baseline) and on day 7 postoperative (post-intervention). The Chinese version of the DASS-21 has demonstrated high internal consistency in postoperative patient populations: Cronbach's α = 0.89 for depression, α = 0.84 for anxiety, and α = 0.87 for stress. Confirmatory factor analysis supported good model fit (comparative fit index = 0.92, root mean square error of approximation = 0.06)

  1 day

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Standard Nursing Care

Behavioral: Standard Nursing Care Protocol

Observation Group

EXPERIMENTAL

MDC-based Pain Management

Behavioral: MDC-based Pain Management

Interventions

Standard Nursing Care Protocol BEHAVIORAL

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).

Control Group

MDC-based Pain Management BEHAVIORAL

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.

Observation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years (adult patients capable of cooperating with assessments and interventions; pediatric patients were excluded due to developmental differences in pain perception and response);
• 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).

You may not qualify if:

• Diagnosis of inflammatory bowel disease, colorectal malignancy, or active intestinal infection; presence of significant dysfunction in major organs (e.g., ASA \[American Society of Anesthesiologists\] physical status classification ≥ III), autoimmune diseases, or long-term use of immunosuppressants or corticosteroids;
• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospita

Beijing, Beijing City, 100029, China

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ying Zhang

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 2, 2025
• Study Start: July 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 10, 2024
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)