A Before and After Study Studying the Impact of an Analgesia Protocol After Discharge From Outpatient Surgery

February 12, 2024 updated by: Samalea Suarez Nicolas, MD, Centre Hospitalier Universitaire de Liege

The goal of this before and after study is to measure the effectiveness of a home analgesia protocol after outpatient surgery in a tertiary hospital. The main question it aims to answer is:

- Measure the impact of the protocol on the proportion of patients with a VAS greater than 3/10 on day one and who did not take the analgesics.

The participants are divided into two groups. The control group leaves the hospital with instructions and prescriptions. The experimental group leaves the hospital with instructions, analgesics for a maximum of two days with detailed dosages and an explanatory booklet on postoperative pain.

Study Overview

Study Type

Observational

Enrollment (Actual)

1423

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wallonie
      • Liège, Wallonie, Belgium, 4000
        • CHU de Liège

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients who underwent outpatient surgery at the Liège university hospital center in Belgium

Description

Inclusion Criteria:

  • outpatient surgery
  • no age limit
  • accepted post-operative monitoring by text messages (SMS)

Exclusion Criteria:

  • refusal of post-operative follow-up by text messages (SMS)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control group
The control group is made up of patients, without age limit, who underwent an outpatient surgery from 01/09/19 to 28/02/20 inclusive and accepted post-operative monitoring by SMS. These patients leaves the hospital with instructions and prescriptions.
experimental group
The experimental group is made up of patients, without age limit, who underwent an outpatient surgery procedure from 1/9/21 to 28/2/22 inclusive and accepted post-operative monitoring by SMS. The patients leaves the hospital with instructions, analgesics for a maximum of two days with detailed dosages and an explanatory booklet on postoperative pain.
Measure the impact of the home analgesia protocol on the proportion of patients with a VAS > 3/10 on D+1 and who did not take analgesics. The protocol consists of providing the patient with instructions at the time of discharge, analgesics for a maximum of two days with dosages and an explanatory booklet on pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the impact of the protocol on the proportion of patients with a pain greater than 3/10 on a Visual Analogue Scale at day one and who did not take the analgesics.
Time Frame: day 1

Visual Analogue Scale = 0/10 : no pain Visual Analogue Scale = 10/10: maximal pain The patients receive a text message (SMS) on day 1 asking for their pain level between 1 and 10. They send the response via SMS. If the response is greater than 3/10, an SMS asks patients if they have taken their painkillers. If they took them, they say "taken". Otherwise, they are invited to take them and are contacted again 45 minutes later for a new evaluation.

In the event of no response to the SMS or pain > 3/10 despite taking the prescribed painkillers, they are contacted by telephone.

day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the adequacy of post-op analgesics by measuring the proportion of patients with a Visual Analogue Scale < or = 3/10 on day one for each group
Time Frame: day 1

Visual Analogue Scale = 0/10 : no pain Visual Analogue Scale = 10/10: maximal pain The patients receive a text message (SMS) on day 1 asking for their pain level between 1 and 10. They send the response via SMS. If the response is greater than 3/10, an SMS asks patients if they have taken their painkillers. If they took them, they say "taken". Otherwise, they are invited to take them and are contacted again 45 minutes later for a new evaluation.

In the event of no response to the SMS or pain > 3/10 despite taking the prescribed painkillers, they are contacted by telephone.

day 1
Measure the impact of the protocol on the occurrence of nausea and vomiting on day one
Time Frame: day 1

The patients receive a text message (SMS) on day 1 asking for their pain level between 1 and 10. The patients receive a text message (SMS) on day 1 asking if they suffer from nausea and vomiting. If the answer is no, they respond 0 to the SMS. If the answer is yes, they answer 1.

In the event of no response to the SMS or the présence nausea and vomiting, they are contacted by telephone.

day 1
Measure the impact of the protocol on general satisfaction of stay in outpatient surgery on day 7 with a Visual Analogue Scale Satisfaction
Time Frame: day 7
The patients receive a text message (SMS) on day 7 to know their satisfaction. A Visual Analogue Scale Satisfaction is used. A Visual Analogue Scale Satisfaction = 0: the worst experience. A Visual Analogue Scale Satisfaction = 10: the best experience
day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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