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NCT Number: NCT07183345

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

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).

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Key information

Conditions

Incarcerated Mixed Hemorrhoids Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Affiliated Hospital of Putian University

Putian, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dynamic Pain Assessment and Management System

Other

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.

Routine drug analgesia

Drug

adopted routine drug analgesia and conventional nursing education

Primary outcomes

  1. Pain Numerical Rating Scale (NRS)

    Time frame: Baseline, Day 1, 3, 5, 7, and Day 14±2

    The 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 outcomes

  1. Incidence Rate of Complications

    Time frame: within 30 days after surgery

    Measurements include the incidence rate of complications such as postoperative hemorrhage and urinary retention

  2. Length of Hospital Stay

    Time frame: from the end of surgery to discharge (a maximum of 7 days)

    with hours as the unit, and standardized discharge criteria are adopted.

Study contacts

Contact information is provided by the study sponsor or research team.

Chenxing Jian

CONTACT

[email protected]

+8613959538950

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Putian University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Sep 19, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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