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Comparison Between Pre-operative Prescription Delivered During Anesthesia Consultation or Post-operative Prescription

NCT03205189 — Not applicable, Completed, 200 participants, University Hospital, Rouen

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Comparison Between Pre-operative Prescription Delivered During Anesthesia Consultation or Post-operative Prescription: a Randomized Prospective Trial

RegistryNCT03205189, acronym AMBUPRESS
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment200 (Actual)
SponsorUniversity Hospital, Rouen (Other)
ConditionsPostoperative Pain, Ambulatory Surgery, Anesthesia, Postoperative Complication
InterventionsComparison between pre-operative prescription and post-operative prescription (Other)
Datesstart 2017-05-01, primary completion 2018-12-31, completion 2018-12-31, first posted 2017-07-02, last updated 2026-03-02
Locations1 site in France

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Pre-operative prescription groupOtherOther: Comparison between pre-operative prescription and post-operative prescriptionThis group will have a pre-operative prescription delivered during the preoperative anesthesia clinic.
Postoperative prescription groupOtherOther: Comparison between pre-operative prescription and post-operative prescriptionThis group will receive the postoperative prescription.
  • Comparison between pre-operative prescription and post-operative prescription (Other): The first group will have a pre-operative prescription delivered during the preoperative anesthesia clinic and the second group will receive the postoperative prescription.

+Outcome measures

Primary outcomes

  • Early home pain after ambulatory surgery [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.

Secondary outcomes

  • Intense painful experience during hospitalisation [Day 1]: Incidence of a pain experience at mobilization or at rest of intensity greater than 3 on a scale from 0 to 10 during hospitalisation.
  • Low painful experience during hospitalisation [Day 1]: Incidence of a pain experience at mobilization or at rest of intensity lower than 3 on a scale from 0 to 10 during hospitalisation.
  • Low home pain experience [24 hours after ambulatory surgery]: 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
  • Intense home pain experience [Within 7 days after ambulatory surgery]: 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.
  • Low home pain experience [Within 7 days after ambulatory surgery]: 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
  • Adherence to analgesic treatment [Within 7 days after ambulatory surgery]: Adherence to analgesic treatment in relation to prescription (yes or not)
  • Patient's satisfaction [Within 7 days after ambulatory surgery]: Patient's satisfaction with prescribed treatment (scale from 0 to 10, satisfying opinion defined by a score greater than 8)
  • Use of morphine analgesics [Within 7 days after ambulatory surgery]: Incidence of morphine analgesic use

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Rouen University HospitalRouenFrance

+Publications

  • Results publication: 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. PMID 33982238

+Investigators

  • Vincent COMPERE, Pr, Principal investigator, University Hospital, Rouen

My Notes