Affiliated Hospital of Putian University
Putian, Fujian, China
NCT Number: NCT07358065
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Putian, Fujian, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.).
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.
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.
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.
Time frame: From enrollment to 1 month after discharge
Total postoperative analgesic consumption: Convert all analgesics to morphine equivalent dose (MEDD) for intergroup comparison to evaluate the opioid-sparing effect of the regimen.
Contact information is provided by the study sponsor or research team.
The Affiliated Hospital of Putian University
Other
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