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

NCT03471156 | Completed DMC

• 1 other identifier: LNR/15/WMEAD/25
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of patients with EMR related pain post-procedurally

  Patients are observed for pain post-procedurally and data collected on when/how pain is relieved

  up to 24 hours

Secondary Outcomes (1)

• Correlate post-procedural pain with procedural data

  up to 24 hours

Study Arms (1)

Post EMR

Patients are observed post EMR procedure for pain. Standard of care data is collected

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 were recorded.

You may qualify if:

• All patients referred to Westmead Hospital Endoscopy Unit to undergo an EMR of a colonic lesion reported to be ≥20mm in size.
• Age ≥18 years.
• Patients able to give informed consent to involvement in the trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent.

You may not qualify if:

• Inability to sign informed consent.

Sponsors & Collaborators

• Western Sydney Local Health District: lead

Study Sites (1)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Related Publications (1)

• Desomer L, Tate DJ, Pillay L, Awadie H, Sidhu M, Ahlenstiel G, Bourke MJ. Intravenous paracetamol for persistent pain after endoscopic mucosal resection discriminates patients at risk of adverse events and those who can be safely discharged. Endoscopy. 2023 Jul;55(7):611-619. doi: 10.1055/a-2022-6530. Epub 2023 Jan 30.

  PMID: 36716781 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Medicine

Study Record Dates

• First Submitted: July 9, 2017
• First Posted: March 20, 2018
• Study Start: August 27, 2015
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2021
• Last Updated: June 29, 2023

Record last verified: 2023-06

Locations

AU (1)