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

T

The Affiliated Hospital of Putian University

Status and phase

Not yet enrolling
Early Phase 1

Conditions

Incarcerated Mixed Hemorrhoids

Treatments

Other: Dynamic Pain Assessment and Management System
Drug: Routine drug analgesia

Study type

Interventional

Funder types

Other

Identifiers

NCT07183345
putianU-006

Details and patient eligibility

About

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).

Enrollment

64 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

64 participants in 2 patient groups

control group
Other group
Description:
adopted routine drug analgesia
Treatment:
Drug: Routine drug analgesia
study group
Other group
Description:
Adoption of a Dynamic Pain Assessment and Management System
Treatment:
Other: Dynamic Pain Assessment and Management System

Trial contacts and locations

1

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Central trial contact

Chenxing Jian

Data sourced from clinicaltrials.gov

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