- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06268587
A Before and After Study Studying the Impact of an Analgesia Protocol After Discharge From Outpatient Surgery
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
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Wallonie
-
Liège, Wallonie, Belgium, 4000
- CHU de Liège
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/80
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