跳至主要内容
临床试验/NCT07150819
NCT07150819撤回不适用

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

China-Japan Friendship Hospital2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
126
试验地点
2
主要终点
Short-Form McGill Pain Questionnaire (SF-MPQ)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

Short-Form McGill Pain Questionnaire (SF-MPQ)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

Short-Form McGill Pain Questionnaire (SF-MPQ)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

次要结局

未报告次要终点

研究者

发起方
China-Japan Friendship Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ying Zhang

Associate Chief Physician

China-Japan Friendship Hospital

研究点 (2)

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