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

U

University Hospital, Rouen

Status

Unknown

Conditions

Ambulatory Surgery
Postoperative Pain
Postoperative Complication
Anesthesia

Treatments

Other: Comparison between pre-operative prescription and post-operative prescription

Study type

Interventional

Funder types

Other

Identifiers

NCT03205189
2015/119/SC

Details and patient eligibility

About

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.

Full 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.

Enrollment

186 estimated patients

Sex

All

Ages

18+ years old

Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

186 participants in 2 patient groups

Pre-operative prescription group
Other group
Description:
This group will have a pre-operative prescription delivered during the preoperative anesthesia clinic.
Treatment:
Other: Comparison between pre-operative prescription and post-operative prescription
Postoperative prescription group
Other group
Description:
This group will receive the postoperative prescription.
Treatment:
Other: Comparison between pre-operative prescription and post-operative prescription

Trial contacts and locations

1

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Central trial contact

Julien BLOT; Vincent COMPERE

Data sourced from clinicaltrials.gov

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