A Multidisciplinary Perioperative Pain Management

Not Applicable

Completed

• Conditions: Anorectal Surgery; Pain Management

• Registration Number: NCT07150819
• Lead Sponsor: China-Japan Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-07-20
• Status Verified: 2025-08
• Study First Submitted: 2025-08-28
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-02
• Last Update Posted: 2025-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Short-Form McGill Pain Questionnaire (SF-MPQ)	4 hours	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).
Dynamic Pain Intensity Monitoring	4 hours	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)
Postoperative Recovery Indicators	4 hours	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.
Postoperative Complication Monitoring	1 Day	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.
Psychological Status Assessment	1 day	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)

Trial Locations

Locations (1)

China-Japan Friendship Hospita; 🇨🇳 Beijing, Beijing City, China