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Application of Dynamic Pain Assessment and Management System in Perioperative Period of Patients With Incarcerated Mixed Hemorrhoids

Application of Dynamic Pain Assessment and Management System in Perioperative Period of Patients With Incarcerated Mixed Hemorrhoids: A Single-Center, Prospective, Open-Label, Randomized Controlled Trial

Status
Not yet recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07183345
Enrollment
64
Registered
2025-09-19
Start date
2026-09-01
Completion date
2028-05-31
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incarcerated Mixed Hemorrhoids

Keywords

Pain Management, Preoperative Analgesia, Traditional Chinese Medicine (TCM) Fumigation, Wrist-Ankle Acupuncture (WAA), Dynamic Pain Management

Brief summary

This study aims to investigate whether the dynamic pain assessment and management system can alleviate postoperative pain in patients with incarcerated mixed hemorrhoids and reduce the incidence of complications. A total of 64 eligible patients were enrolled and randomly divided into two groups, with the specific grouping and intervention methods as follows: ① Control Group: Routine drug analgesia and conventional nursing education were adopted. ② Study Group: Patients were managed with the dynamic pain assessment and management system, which included preoperative administration of analgesic drugs, postoperative traditional Chinese medicine (TCM) fumigation, wrist-ankle acupuncture for pain relief, and personalized nursing education. The study evaluated the effect of the dynamic pain assessment and management system on postoperative analgesia by comparing the Numerical Rating Scale (NRS) scores for pain, recording the Visual Analogue Scale (VAS) scores for quality of life, and analyzing the incidence of complications among patients in different groups. The primary hypothesis of the study is that, compared with routine pain management methods, the dynamic pain assessment and management system can significantly reduce postoperative pain in patients, improve their quality of life, and decrease the incidence of complications (such as bleeding and urinary retention).

Interventions

OTHERDynamic Pain Assessment and Management System

Personalized nursing education was adopted. These measures include the use of preoperative analgesic drugs, postoperative Traditional Chinese Medicine (TCM) fumigation, and wrist-ankle acupuncture for pain relief.

DRUGRoutine drug analgesia

adopted routine drug analgesia and conventional nursing education

Sponsors

The Affiliated Hospital of Putian University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Aged between 18 and 75 years old * Diagnosed with grade III-IV incarcerated mixed hemorrhoids according to the Goligher classification * Undergoing standard hemorrhoidectomy * Receiving simple intraspinal anesthesia

Exclusion criteria

* Pregnant or lactating patients * Patients receiving immunotherapy or with coagulation dysfunction * Patients who need to use various analgesic drugs daily * Complicated with other anorectal diseases (such as perianal abscess, anal fistula, anal incontinence) * Complicated with other systemic diseases (cardiac insufficiency; hepatic or renal insufficiency; diabetes mellitus; coagulation disorders; peptic ulcer, etc.) * Incomplete perioperative clinical data * Unable to cooperate with follow-up

Design outcomes

Primary

MeasureTime frameDescription
Pain Numerical Rating Scale (NRS)Baseline, Day 1, 3, 5, 7, and Day 14±2The NRS uses a linear numerical range of "0 to 10" to represent pain intensity. Patients select the corresponding number based on their own perception, where a score of 0 indicates no pain at all, and a score of 10 represents the most severe pain you can imagine.

Secondary

MeasureTime frameDescription
Incidence Rate of Complicationswithin 30 days after surgeryMeasurements include the incidence rate of complications such as postoperative hemorrhage and urinary retention
Length of Hospital Stayfrom the end of surgery to discharge (a maximum of 7 days)with hours as the unit, and standardized discharge criteria are adopted.

Countries

China

Contacts

CONTACTChenxing Jian
ptyyjcx@126.com+8613959538950

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026