Comparison Between Pre-operative Prescription Delivered During Anesthesia Consultation or Post-operative Prescription: a Randomized Prospective Trial
| Registry | NCT03205189, acronym AMBUPRESS |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 200 (Actual) |
| Sponsor | University Hospital, Rouen (Other) |
| Conditions | Postoperative Pain, Ambulatory Surgery, Anesthesia, Postoperative Complication |
| Interventions | Comparison between pre-operative prescription and post-operative prescription (Other) |
| Dates | start 2017-05-01, primary completion 2018-12-31, completion 2018-12-31, first posted 2017-07-02, last updated 2026-03-02 |
| Locations | 1 site in France |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Pre-operative prescription group | Other | Other: Comparison between pre-operative prescription and post-operative prescription | This 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 prescription | This group will receive the postoperative prescription. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * Any major ambulatory surgery patient with general anesthesia. Exclusion Criteria: * Pregnancy. * Minor patient. * ASA score > 3. * lack of general anesthesia. * General anesthesia combined with locoregional anesthesia. * Contraindication to ambulatory surgery. * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Rouen University Hospital | Rouen | France |