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

NCT07183345 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: putianU-006
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Incarcerated Mixed Hemorrhoids

Keywords

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

Outcome Measures

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.

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

Secondary Outcomes (2)

• Incidence Rate of Complications

  within 30 days after surgery

• Length of Hospital Stay

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

Study Arms (2)

control group

OTHER

adopted routine drug analgesia

Drug: Routine drug analgesia

study group

OTHER

Adoption of a Dynamic Pain Assessment and Management System

Other: Dynamic Pain Assessment and Management System

Interventions

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.

study group

Routine drug analgesia DRUG

adopted routine drug analgesia and conventional nursing education

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Hospital of Putian University: lead

Study Sites (1)

Affiliated Hospital of Putian University

Putian, China

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chenxing Jian

CONTACT

+8613959538950; ptyyjcx@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 19, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)