Anorectal SurgeryNCT07150819
A Multidisciplinary Perioperative Pain Management
A study testing Standard Nursing Care Protocol and MDC-based Pain Management in people with Anorectal Surgery and Pain Management, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorectal Surgery, Pain Management
- What is being tested?
- Standard Nursing Care Protocol and MDC-based Pain Management
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Multidisciplinary Perioperative Pain Management Model in Enhancing Recovery After Anorectal Surgery
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
- Anorectal Surgery, Pain Management
- Being tested
- Standard Nursing Care Protocol, MDC-based Pain Management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Nursing Care ProtocolBehavioural
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 ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Standard Nursing Care Receives: Behavioral: Standard Nursing Care Protocol |
| Observation Group | Experimental | MDC-based Pain Management Receives: Behavioral: MDC-based Pain Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Jul 2022
- Primary completion30 Dec 2023
- Study completion10 Dec 2024
Why it stopped: This research plan needs to be readjusted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal SurgeryStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Zhang, China-Japan Friendship Hospital
- Investigators
- Ying Zhang, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150819
- Sponsor's protocol ID
- ChinaJapanFH010
- Status last verified
- Dec 2025
- First submitted
- 28 Aug 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multidisciplinary Perioperative Pain Management Model in Enhancing Recovery After Anorectal Surgery
- ClinicalTrials.gov ID
- NCT07150819
- Acronym / sponsor ID
- ChinaJapanFH010
- Conditions
- Anorectal Surgery, Pain Management
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This research plan needs to be readjusted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Standard Nursing Care ProtocolStandard Nursing Care |
| Observation Group | Experimental | Behavioral: MDC-based Pain ManagementMDC-based Pain Management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard 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). | Behavioural | Control Group |
| MDC-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. | Behavioural | Observation Group |
Primary outcome
Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Zhang principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Nursing Care Protocol and MDC-based Pain Management in people with Anorectal Surgery and Pain Management, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-Form McGill Pain Questionnaire (SF-MPQ) (time frame: 4 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.