Postoperative PainNCT06268587
A Before and After Study Studying the Impact of an Analgesia Protocol After Discharge From Outpatient Surgery
An observational study of Postoperative Pain and Outpatient Surgery, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain, Outpatient Surgery
- What is being tested?
- Measure the impact of the home analgesia protocol on the proportion of patients with a VAS > 3/10 on day one and who did not take analgesics.
- How many people
- 1,423 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2019to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who underwent outpatient surgery at the Liège university hospital center in Belgium
Who may be able to join
- outpatient surgery
- no age limit
- accepted post-operative monitoring by text messages (SMS)
Who cannot join
- refusal of post-operative follow-up by text messages (SMS)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Postoperative Pain, Outpatient Surgery
- Being tested
- Measure the impact of the home analgesia protocol on the proportion of patients with a VAS > 3/10 on day one and who did not take analgesics.
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure the impact of the home analgesia protocol on the proportion of patients with a VAS > 3/10 on day one and who did not take analgesics.Combination product
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Measure the impact of the home analgesia protocol on the proportion of patients with a VAS > 3/10 on day one and who did not take analgesics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: day 1
Secondary outcomes (3)
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
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.
Measured: day 1
Measure the impact of the protocol on the occurrence of nausea and vomiting on day one
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.
Measured: 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
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
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Sep 2019
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samalea Suarez Nicolas, MD, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268587
- Sponsor's protocol ID
- 2023/80
- Status last verified
- Feb 2024
- First submitted
- 26 Dec 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Before and After Study Studying the Impact of an Analgesia Protocol After Discharge From Outpatient Surgery
- ClinicalTrials.gov ID
- NCT06268587
- Acronym / sponsor ID
- 2023/80
- Conditions
- Postoperative Pain, Outpatient Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,423 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Combination Product: Measure the impact of the home analgesia protocol on the proportion of patients with a VAS &gt; 3/10 on day one and who did not take analgesics.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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent outpatient surgery at the Liège university hospital center in Belgium
Key inclusion criteria (3 listed)
- outpatient surgery
- no age limit
- accepted post-operative monitoring by text messages (SMS)
Key exclusion criteria (1 listed)
- refusal of post-operative follow-up by text messages (SMS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure the impact of the home analgesia protocol on the proportion of patients with a VAS &gt; 3/10 on day one and who did not take analgesics.Measure the impact of the home analgesia protocol on the proportion of patients with a VAS \&gt; 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 | Combination product | experimental group |
Primary outcome
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.
3 secondary outcomes
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
Measure the impact of the protocol on the occurrence of nausea and vomiting on day one
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Outpatient Surgery, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.