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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Putian University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dynamic Pain Assessment and Management System

    Other intervention

    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

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: control groupOther 1 intervention
Group B: study groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Pain Numerical Rating Scale (NRS)

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.

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

Secondary outcomes

1

Incidence Rate of Complications

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

Time frame
within 30 days after surgery
2

Length of Hospital Stay

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

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

Other outcomes

Sponsors and contacts

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