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Not yet recruiting NCT07183345

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

Early Phase I Interventional Incarcerated Mixed Hemorrhoids

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dynamic Pain Assessment and Management System, Routine drug analgesia.
Who it may be relevant to
Registry conditions: Incarcerated Mixed Hemorrhoids. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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

  • Other Dynamic 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.
  • Drug Routine drug analgesia
    adopted routine drug analgesia and conventional nursing education

Primary outcome measures

  • Pain Numerical Rating Scale (NRS) [Time frame: Baseline, Day 1, 3, 5, 7, and Day 14±2]
Secondary outcome measures (2)
  • Incidence Rate of Complications [Time frame: within 30 days after surgery]
  • Length of Hospital Stay [Time frame: from the end of surgery to discharge (a maximum of 7 days)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

China · 1 center
  • Affiliated Hospital of Putian University — Putian

Identifiers

NCT: NCT07183345 · putianU-006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗