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NOT YET RECRUITING
NCT07358065
NA

Clinical Application of Dynamic Multimodal Analgesia Regimen After Perianal Abscess Surgery

Sponsor: The Affiliated Hospital of Putian University

View on ClinicalTrials.gov

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. 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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2026-01-01

Completion Date

2026-12-31

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

DRUG

the traditional analgesic mode

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.).

BEHAVIORAL

Western Medicine Multimodal Analgesia

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. 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.

BEHAVIORAL

Integrated Traditional Chinese and Western Medicine Multimodal Analgesia

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.

Locations (1)

Affiliated Hospital of Putian University

Putian, Fujian, China