Postoperative PainAMBUPRESSNCT03205189
Comparison Between Pre-operative Prescription Delivered During Anesthesia Consultation or Post-operative Prescription
A study testing Comparison between pre-operative prescription and post-operative prescription in people with Postoperative Pain and Ambulatory Surgery, run by University Hospital, Rouen at 1 site in France.
Trial summary
This study evaluates the comparison of the incidence of postoperative home pain after ambulatory surgery with general anesthesia between a group with pre-surgical prescription delivered during anesthesia preoperative clinic and a group with postoperative prescription. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Ambulatory Surgery, Anesthesia
- What is being tested?
- Comparison between pre-operative prescription and post-operative prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2017to 31 Dec 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any major ambulatory surgery patient with general anesthesia.
Who cannot join
- Pregnancy.
- Minor patient.
- ASA score > 3.
- lack of general anesthesia.
- General anesthesia combined with locoregional anesthesia.
- Contraindication to ambulatory surgery.
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- Chronic pain.
- chronic analgesic consumption.
- no indication of non steroidal anti-inflammatory drug, paracetamol with codeine and morphine.
- Active or old drug addiction.
- Cognitive disorders or dementia.
- Serious psychiatric disorders.
- Patient under curatorship or tutorship.
- No social protection
- Misunderstanding of the French language
- Patient participating in another trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Pre-operative Prescription Delivered During Anesthesia Consultation or Post-operative Prescription: a Randomized Prospective Trial
This study evaluates the comparison of the incidence of postoperative home pain after ambulatory surgery with general anesthesia between a group with pre-surgical prescription delivered during anesthesia preoperative clinic and a group with postoperative prescription.
Read the detailed description
The ambulatory surgery increased over the last twenty years in France. The management of home pain after ambulatory surgery is a major challenge because it is the principal complication after day surgery with several consequences: nausea and vomiting, chronic pain, functional impairment with handicap, sleeping troubles, extra-hospital consultation. Management of home pain remains currently could be performed in ambulatory surgery. The French Society of Anesthesiology recommends to deliver pre-surgical prescription during the preoperative anesthesia clinic but this guideline is not bases on evidence in the literature. Also, we have previously shown in a retrospective non-randomized work a decrease of postoperative home pain in patient with general anesthesia. The main objective of this controlled and comparative study is to compare the incidence of postoperative home pain after ambulatory surgery with general anesthesia between a group with pre-surgical prescription delivered during anesthesia consultation and a group with postoperative prescription.
- Being tested
- Comparison between pre-operative prescription and post-operative prescription
- Keywords
- postoperative pain, ambulatory surgery, general anesthesia, anesthesia consultation, post-op prescription
- Medical subject headings
- Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison between pre-operative prescription and post-operative prescriptionOther
The first group will have a pre-operative prescription delivered during the preoperative anesthesia clinic and the second group will receive the postoperative prescription.
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative prescription group | Other | This group will have a pre-operative prescription delivered during the preoperative anesthesia clinic. Receives: Other: Comparison between pre-operative prescription and post-operative prescription |
| Postoperative prescription group | Other | This group will receive the postoperative prescription. Receives: Other: Comparison between pre-operative prescription and post-operative prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early home pain after ambulatory surgery
The primary outcome is the incidence of at least one home pain experience with intensity greater than 3 on a scale from 0 to 10 within 24 hours after surgery.
Measured: 24 hours after ambulatory surgery
Secondary outcomes (8)
Intense painful experience during hospitalisation
Incidence of a pain experience at mobilization or at rest of intensity greater than 3 on a scale from 0 to 10 during hospitalisation.
Measured: Day 1
Low painful experience during hospitalisation
Incidence of a pain experience at mobilization or at rest of intensity lower than 3 on a scale from 0 to 10 during hospitalisation.
Measured: Day 1
Low home pain experience
Incidence of a pain experience at mobilization or at rest of intensity lower than 3 at home on a scale from 0 to 10 within 24 hours after surgery
Measured: 24 hours after ambulatory surgery
Intense home pain experience
Incidence of home pain at mobilization or at rest of intensity greater than 3 on a scale from 0 to 10 within 7 days after surgery.
Measured: Within 7 days after ambulatory surgery
Low home pain experience
Incidence of home pain at mobilization or at rest of intensity lower than 3 at home on a scale from 0 to 10 within 7 days after surgery
Measured: Within 7 days after ambulatory surgery
Adherence to analgesic treatment
Adherence to analgesic treatment in relation to prescription (yes or not)
Measured: Within 7 days after ambulatory surgery
Patient's satisfaction
Patient's satisfaction with prescribed treatment (scale from 0 to 10, satisfying opinion defined by a score greater than 8)
Measured: Within 7 days after ambulatory surgery
Use of morphine analgesics
Incidence of morphine analgesic use
Measured: Within 7 days after ambulatory surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 May 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, prospective, study
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent COMPERE, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205189
- Sponsor's protocol ID
- 2015/119/SC
- Acronym
- AMBUPRESS
- Status last verified
- Feb 2026
- First submitted
- 15 Jun 2017
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Selim J, Djerada Z, Chaventre C, Clavier T, Dureuil B, Besnier E, Compere V. Preoperative analgesic instruction and prescription reduces early home pain after outpatient surgery: a randomized controlled trial. Can J Anaesth. 2022 Aug;69(8):1033-1041. doi: 10.1007/s12630-021-02023-0. Epub 2021 May 13.
PubMed 33982238
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Pre-operative Prescription Delivered During Anesthesia Consultation or Post-operative Prescription: a Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT03205189
- Acronym / sponsor ID
- AMBUPRESS / 2015/119/SC
- Keywords
- postoperative pain, ambulatory surgery, general anesthesia, anesthesia consultation, post-op prescription
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 Jul 2017 (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.
This study evaluates the comparison of the incidence of postoperative home pain after ambulatory surgery with general anesthesia between a group with pre-surgical prescription delivered during anesthesia preoperative clinic and a group with postoperative prescription.
Detailed description
The ambulatory surgery increased over the last twenty years in France. The management of home pain after ambulatory surgery is a major challenge because it is the principal complication after day surgery with several consequences: nausea and vomiting, chronic pain, functional impairment with handicap, sleeping troubles, extra-hospital consultation. Management of home pain remains currently could be performed in ambulatory surgery. The French Society of Anesthesiology recommends to deliver pre-surgical prescription during the preoperative anesthesia clinic but this guideline is not bases on evidence in the literature. Also, we have previously shown in a retrospective non-randomized work a decrease of postoperative home pain in patient with general anesthesia. The main objective of this controlled and comparative study is to compare the incidence of postoperative home pain after ambulatory surgery with general anesthesia between a group with pre-surgical prescription delivered during anesthesia consultation and a group with postoperative prescription.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, prospective, study
| Arm | Type | Receives |
|---|---|---|
| Pre-operative prescription group | Other | Other: Comparison between pre-operative prescription and post-operative prescriptionThis group will have a pre-operative prescription delivered during the preoperative anesthesia clinic. |
| Postoperative prescription group | Other | Other: Comparison between pre-operative prescription and post-operative prescriptionThis group will receive the postoperative prescription. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any major ambulatory surgery patient with general anesthesia.
Key exclusion criteria (16 listed)
- Pregnancy.
- Minor patient.
- ASA score > 3.
- lack of general anesthesia.
- General anesthesia combined with locoregional anesthesia.
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 |
|---|---|---|
| Comparison between pre-operative prescription and post-operative prescriptionThe first group will have a pre-operative prescription delivered during the preoperative anesthesia clinic and the second group will receive the postoperative prescription. | Other | Postoperative prescription group, Pre-operative prescription group |
Primary outcome
Early home pain after ambulatory surgery
Time frame: 24 hours after ambulatory surgery
The primary outcome is the incidence of at least one home pain experience with intensity greater than 3 on a scale from 0 to 10 within 24 hours after surgery.
8 secondary outcomes
Intense painful experience during hospitalisation
Time frame: Day 1
Low painful experience during hospitalisation
Time frame: Day 1
Low home pain experience
Time frame: 24 hours after ambulatory surgery
Intense home pain experience
Time frame: Within 7 days after ambulatory surgery
Low home pain experience
Time frame: Within 7 days after ambulatory surgery
Adherence to analgesic treatment
Time frame: Within 7 days after ambulatory surgery
Patient's satisfaction
Time frame: Within 7 days after ambulatory surgery
Use of morphine analgesics
Time frame: Within 7 days after ambulatory surgery
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 2 Mar 2026.
- Derived from this study: PubMed 33982238Selim J, Djerada Z, Chaventre C, Clavier T, Dureuil B, Besnier E, Compere V. Preoperative analgesic instruction and prescription reduces early home pain after outpatient surgery: a randomized controlled trial. Can J Anaesth. 2022 Aug;69(8):1033-1041. doi: 10.1007/s12630-021-02023-0. Epub 2021 May 13.
- Individual participant dataSharing planned: No
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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.
Vincent COMPERE, Pr principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison between pre-operative prescription and post-operative prescription in people with Postoperative Pain and Ambulatory Surgery, run by University Hospital, Rouen at 1 site in France.
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 1 inclusion and 16 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 2 Mar 2026. 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 France. 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?
Early home pain after ambulatory surgery (time frame: 24 hours after ambulatory surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03205189, which also lists 1 linked publication.
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 2 Mar 2026.