Clinical Application of Dynamic Multimodal Analgesia Regimen After Perianal Abscess SurgeryNCT07358065
Clinical Application of Dynamic Multimodal Analgesia Regimen After Perianal Abscess Surgery
A study testing the traditional analgesic mode, Western Medicine Multimodal Analgesia and Integrated Traditional Chinese and Western Medicine Multimodal Analgesia in people with Clinical Application of Dynamic Multimodal Analgesia Regimen After Perianal Abscess Surgery, run by The Affiliated Hospital of Putian University at 1 site in China.
Trial summary
This study aims to investigate whether the full-course multimodal analgesia regimen based on dynamic assessment (including the integrated traditional Chinese and Western medicine mode) can alleviate postoperative pain, reduce opioid dosage, and decrease the incidence of complications in patients with perianal abscess. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Clinical Application of Dynamic Multimodal Analgesia Regimen After Perianal Abscess Surgery
- What is being tested?
- the traditional analgesic mode, Western Medicine Multimodal Analgesia and Integrated Traditional Chinese and Western Medicine Multimodal Analgesia
- 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
- 135 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with primary perianal abscess by clinical examinations (digital rectal examination, ultrasound, or MRI) and undergoing incision and drainage or radical surgical treatment;
- Abscess diameter ≥ 2 cm or accompanied by obvious abscess cavity formation;
- Patients are willing and able to participate in the pain management plan, understand the importance of pain management, and actively cooperate;
- No severe coagulation disorders.
Who cannot join
- Complicated with specific infectious diseases such as Crohn's disease or tuberculosis;
- Unclear source of postoperative pain (i.e., the patient's pain is uncertain or unrelated to the surgery);
- Having definite contraindications, including drug allergies or inability to accept certain pain management methods adopted in the study;
- Pregnant or lactating women;
- Patients unable to cooperate with the study, such as those with cognitive impairment, history of mental illness, or communication difficulties;
- Patients with long-term use of analgesic drugs and developed drug tolerance;
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- Complicated with uncontrolled cardiovascular and cerebrovascular diseases (NYHA cardiac function Class Ⅲ-Ⅳ), liver or kidney insufficiency (Child-Pugh Class C or eGFR < 30 ml/min/1.73m²), etc.;
- Abscess secondary to rectal tumors, trauma, or iatrogenic injury;
- Postoperative occurrence of severe complications (e.g., massive hemorrhage, sepsis) or combined infection in other parts;
- Patients receiving only non-surgical treatments such as simple puncture and aspiration of pus.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to investigate whether the full-course multimodal analgesia regimen based on dynamic assessment (including the integrated traditional Chinese and Western medicine mode) can alleviate postoperative pain, reduce opioid dosage, and decrease the incidence of complications in patients with perianal abscess. It also intends to verify the clinical advantages of the integrated traditional Chinese and Western medicine multimodal regimen and establish a promotable standardized pain management pathway. A total of 135 eligible patients will be enrolled and divided into three groups in a 1:1:1 ratio using a single-center, prospective, randomized parallel-controlled design. The specific grouping and intervention methods are as follows: ① Control Group (Group A): Adopts the traditional analgesic mode, where NRS assessment and intervention are conducted only when the patient actively complains of pain (medication administered for scores ≥4 points) without preemptive medication. Medications refer to conventional schemes (e.g., flurbiprofen, diclofenac sodium, etc.). ② Western Medicine Multimodal Analgesia Group (Group B): Implements dynamic assessment + stepwise medication intervention + non-pharmacological auxiliary measures. Baseline NRS score is collected 24 hours before surgery; pain at rest and during activity is assessed at fixed time points after surgery; NSAIDs, opioids, and other medications are administered as needed, combined with potassium permanganate sitz bath, health education, etc. ③ Integrated Traditional Chinese and Western Medicine Multimodal Analgesia Group (Group C): Integrates characteristic traditional Chinese medicine nursing interventions (including auricular point pressing, wrist-ankle acupuncture, traditional Chinese medicine sitz bath, etc.) on the basis of Group B's intervention.
To evaluate the clinical efficacy of the dynamic multimodal analgesia regimen, this study will compare the following indicators among the three groups: NRS pain scores on postoperative days 1, 2, 3, 4, 5, as well as 2 weeks and 1 month after discharge; total postoperative analgesic consumption converted to morphine equivalent dose (MEDD); quality of life score assessed by the SF-36 scale; incidence of complications (such as urinary retention, secondary hemorrhage, etc.); sexual function recovery (assessed by the IIEF-5 scale for males and the FSFI scale for females); and patient satisfaction and compliance. The primary research hypothesis is: compared with conventional analgesia and western medicine-only multimodal analgesia, the integrated traditional Chinese and Western medicine multimodal analgesia regimen can significantly reduce patients' postoperative pain scores, decrease opioid dosage, improve quality of life and patient satisfaction, lower the incidence of complications, and enhance patients' sexual function recovery.
- Conditions
- Clinical Application of Dynamic Multimodal Analgesia Regimen After Perianal Abscess Surgery
- Being tested
- the traditional analgesic mode, Western Medicine Multimodal Analgesia, Integrated Traditional Chinese and Western Medicine Multimodal Analgesia
- Keywords
- Perianal Abscess, Postoperative Pain, Dynamic Assessment, Multimodal Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the traditional analgesic modeDrug
Adopt the traditional analgesic mode: conduct NRS assessment and intervention only when the patient takes the initiative to complain of pain, without fixed assessment time points. Intervene when the pain score is ≥4 points, and no prophylactic medication is administered. Medication use refers to the conventional plan (e.g., flurbiprofen injection, diclofenac sodium capsules, etc.).
Western Medicine Multimodal AnalgesiaBehavioural
Collect baseline NRS score 24 hours before surgery. After surgery, assess NRS in resting and active states at fixed daily time points (e.g., 08:00, 16:00), and conduct on-demand assessment for breakthrough pain. Reassess during outpatient follow-up at 2 weeks and 1 month after discharge.
- Stepwise medication intervention: Administer medications in a stepwise manner based on NRS score. For scores ≤3 points, prioritize non-pharmacological interventions; for scores ≥4 points, initiate NSAIDs, acetaminophen, etc.; for moderate to severe pain, administer bucinazine, pethidine, or other medications as needed.
- Non-pharmacological auxiliary measures: Include potassium permanganate sitz bath, health education, psychological counseling, etc.
- Dynamic adjustment: The pain management team conducts daily rounds to individually adjust the plan based on assessment results.
Integrated Traditional Chinese and Western Medicine Multimodal AnalgesiaBehavioural
On the basis of western medicine multimodal analgesia, integrate characteristic traditional Chinese medicine nursing interventions, such as auricular point pressing, wrist-ankle acupuncture, traditional Chinese medicine sitz bath, etc.
| Study group | Role | What they receive |
|---|---|---|
| Group A ：Conventional Analgesia Group | Other | Adopts the traditional analgesic mode. Receives: Drug: the traditional analgesic mode |
| Group B：Western Medicine Multimodal Analgesia Group | Other | Implements a dynamic assessment-based full-course multimodal analgesia strategy. Receives: Behavioral: Western Medicine Multimodal Analgesia |
| Group C：Integrated Traditional Chinese and Western Medicine Multimodal Analgesia Group | Other | Integrates characteristic traditional Chinese medicine nursing interventions on the basis of western medicine multimodal analgesia. Receives: Behavioral: Integrated Traditional Chinese and Western Medicine Multimodal Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
Postoperative pain score (NRS，Numeric Rating Scale): Record pain scores at rest and during activity on postoperative days 1, 2, 3, 4, 5, as well as at 2 weeks and 1 month after discharge, serving as the core assessment of the analgesic effect of the regimen.NRS，0 points indicate no pain, while 10 points represent the most severe pain.
Measured: From enrollment to 1 month after discharge
Secondary outcomes (1)
Secondary Efficacy Indicators
Total postoperative analgesic consumption: Convert all analgesics to morphine equivalent dose (MEDD) for intergroup comparison to evaluate the opioid-sparing effect of the regimen.
Measured: From enrollment to 1 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Application of Dynamic Multimodal Analgesia Regimen After Perianal Abscess SurgeryStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Putian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Wu, The Affiliated Hospital of Putian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358065
- Sponsor's protocol ID
- PutianU-014
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Based on a strict commitment to participant privacy protection, compliance with the terms of the ethical review protocol, and adherence to the sponsoring institution's policies, IPD from this study will not be shared at this time.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Dynamic Multimodal Analgesia Regimen After Perianal Abscess Surgery
- ClinicalTrials.gov ID
- NCT07358065
- Acronym / sponsor ID
- PutianU-014
- Conditions
- Clinical Application of Dynamic Multimodal Analgesia Regimen After Perianal Abscess Surgery
- Keywords
- Perianal Abscess, Postoperative Pain, Dynamic Assessment, Multimodal Analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Putian UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jan 2026 (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.
This study aims to investigate whether the full-course multimodal analgesia regimen based on dynamic assessment (including the integrated traditional Chinese and Western medicine mode) can alleviate postoperative pain, reduce opioid dosage, and decrease the incidence of complications in patients with perianal abscess. It also intends to verify the clinical advantages of the integrated traditional Chinese and Western medicine multimodal regimen and establish a promotable standardized pain management pathway. A total of 135 eligible patients will be enrolled and divided into three groups in a 1:1:1 ratio using a single-center, prospective, randomized parallel-controlled design. The specific grouping and intervention methods are as follows: ① Control Group (Group A): Adopts the traditional analgesic mode, where NRS assessment and intervention are conducted only when the patient actively complains of pain (medication administered for scores ≥4 points) without preemptive medication. Medications refer to conventional schemes (e.g., flurbiprofen, diclofenac sodium, etc.). ② Western Medicine Multimodal Analgesia Group (Group B): Implements dynamic assessment + stepwise medication intervention + non-pharmacological auxiliary measures. Baseline NRS score is collected 24 hours before surgery; pain at rest and during activity is assessed at fixed time points after surgery; NSAIDs, opioids, and other medications are administered as needed, combined with potassium permanganate sitz bath, health education, etc. ③ Integrated Traditional Chinese and Western Medicine Multimodal Analgesia Group (Group C): Integrates characteristic traditional Chinese medicine nursing interventions (including auricular point pressing, wrist-ankle acupuncture, traditional Chinese medicine sitz bath, etc.) on the basis of Group B's intervention.
To evaluate the clinical efficacy of the dynamic multimodal analgesia regimen, this study will compare the following indicators among the three groups: NRS pain scores on postoperative days 1, 2, 3, 4, 5, as well as 2 weeks and 1 month after discharge; total postoperative analgesic consumption converted to morphine equivalent dose (MEDD); quality of life score assessed by the SF-36 scale; incidence of complications (such as urinary retention, secondary hemorrhage, etc.); sexual function recovery (assessed by the IIEF-5 scale for males and the FSFI scale for females); and patient satisfaction and compliance. The primary research hypothesis is: compared with conventional analgesia and western medicine-only multimodal analgesia, the integrated traditional Chinese and Western medicine multimodal analgesia regimen can significantly reduce patients' postoperative pain scores, decrease opioid dosage, improve quality of life and patient satisfaction, lower the incidence of complications, and enhance patients' sexual function recovery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A ：Conventional Analgesia Group | Other | Drug: the traditional analgesic modeAdopts the traditional analgesic mode. |
| Group B：Western Medicine Multimodal Analgesia Group | Other | Behavioral: Western Medicine Multimodal AnalgesiaImplements a dynamic assessment-based full-course multimodal analgesia strategy. |
| Group C：Integrated Traditional Chinese and Western Medicine Multimodal Analgesia Group | Other | Behavioral: Integrated Traditional Chinese and Western Medicine Multimodal AnalgesiaIntegrates characteristic traditional Chinese medicine nursing interventions on the basis of western medicine multimodal analgesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with primary perianal abscess by clinical examinations (digital rectal examination, ultrasound, or MRI) and undergoing incision and drainage or radical surgical treatment;
- Abscess diameter ≥ 2 cm or accompanied by obvious abscess cavity formation;
- Patients are willing and able to participate in the pain management plan, understand the importance of pain management, and actively cooperate;
- No severe coagulation disorders.
Key exclusion criteria (10 listed)
- Complicated with specific infectious diseases such as Crohn's disease or tuberculosis;
- Unclear source of postoperative pain (i.e., the patient's pain is uncertain or unrelated to the surgery);
- Having definite contraindications, including drug allergies or inability to accept certain pain management methods adopted in the study;
- Pregnant or lactating women;
- Patients unable to cooperate with the study, such as those with cognitive impairment, history of mental illness, or communication difficulties;
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 |
|---|---|---|
| the traditional analgesic modeAdopt the traditional analgesic mode: conduct NRS assessment and intervention only when the patient takes the initiative to complain of pain, without fixed assessment time points. Intervene when the pain score is ≥4 points, and no prophylactic medication is administered. Medication use refers to the conventional plan (e.g., flurbiprofen injection, diclofenac sodium capsules, etc.). | Drug | Group A ：Conventional Analgesia Group |
| Western Medicine Multimodal AnalgesiaCollect baseline NRS score 24 hours before surgery. After surgery, assess NRS in resting and active states at fixed daily time points (e.g., 08:00, 16:00), and conduct on-demand assessment for breakthrough pain. Reassess during outpatient follow-up at 2 weeks and 1 month after discharge. 1. Stepwise medication intervention: Administer medications in a stepwise manner based on NRS score. For scores ≤3 points, prioritize non-pharmacological interventions; for scores ≥4 points, initiate NSAIDs, acetaminophen, etc.; for moderate to severe pain, administer bucinazine, pethidine, or other medications as needed. 2. Non-pharmacological auxiliary measures: Include potassium permanganate sitz bath, health education, psychological counseling, etc. 3. Dynamic adjustment: The pain management team conducts daily rounds to individually adjust the plan based on assessment results. | Behavioural | Group B：Western Medicine Multimodal Analgesia Group |
| Integrated Traditional Chinese and Western Medicine Multimodal AnalgesiaOn the basis of western medicine multimodal analgesia, integrate characteristic traditional Chinese medicine nursing interventions, such as auricular point pressing, wrist-ankle acupuncture, traditional Chinese medicine sitz bath, etc. | Behavioural | Group C：Integrated Traditional Chinese and Western Medicine Multimodal Analgesia Group |
Primary outcome
Postoperative pain score
Time frame: From enrollment to 1 month after discharge
Postoperative pain score (NRS，Numeric Rating Scale): Record pain scores at rest and during activity on postoperative days 1, 2, 3, 4, 5, as well as at 2 weeks and 1 month after discharge, serving as the core assessment of the analgesic effect of the regimen.NRS，0 points indicate no pain, while 10 points represent the most severe pain.
1 secondary outcome
Secondary Efficacy Indicators
Time frame: From enrollment to 1 month after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No. Based on a strict commitment to participant privacy protection, compliance with the terms of the ethical review protocol, and adherence to the sponsoring institution's policies, IPD from this study will not be shared at this time.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the traditional analgesic mode, Western Medicine Multimodal Analgesia and Integrated Traditional Chinese and Western Medicine Multimodal Analgesia in people with Clinical Application of Dynamic Multimodal Analgesia Regimen After Perianal Abscess Surgery, run by The Affiliated Hospital of Putian University 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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 26 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanbing Ye (+8613959528973, 849221968@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score (time frame: From enrollment to 1 month after discharge). 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 26 Jan 2026.