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Prospective Evaluation of Pain Assessment and Management Protocol for Post-procedural Pain After Endoscopic Mucosal Resection of Colonic Polyps >20mm

NCT03471156 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 325

Last updated 2023-06-29

No results posted yet for this study

Summary

Endoscopic mucosal resection (EMR) of large (≥20 mm) laterally spreading colonic lesions (LSL) is safe, effective and superior to surgery. This advantage is based on a day stay model of care, however the most common adverse event is abdominal pain and this is a major impediment to this efficiency. No prospective data exist on the optimal selection of analgesics, the necessary recovery period or the triggers that should alert the practitioner to a more serious trajectory and the need for escalation of care.

We aimed to characterise potential predictors for persistent (\>5 minutes) post-procedural pain (PP) and develop a simple and effective management algorithm for patients with PP based on the need for analgesics in recovery.

Data on consecutive patients with a LSL referred for EMR at a single, tertiary referral centre were included. Patient and lesion characteristics and peri-procedural data were prospectively collected. Standard post EMR care included 2 hours in first stage recovery followed by 1 hour in 2nd stage recovery where clear fluids were given and discharge after if the patients were well. PP was graded from 0 to 10 using a Visual Analogue Scale (VAS). If PP occurred \>5 minutes, 1 gram of paracetamol was administered parenterally and outcomes were monitored. If pain settled the patient was transferred to second stage recovery after medical review. PP \>30 minutes lead to clinical review and upgrade of analgesics to fentanyl, with a starting dose of 25 micrograms (mcg) up to a maximum of 100 mcg. Investigations, admission and interventions for PP are recorded.

Conditions

  • Pain
  • Endoscopic Mucosal Resection

Sponsors & Collaborators

  • Western Sydney Local Health District

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-27
Primary Completion
2019-06-01
Completion
2021-09-01

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03471156 on ClinicalTrials.gov