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NCT Number: NCT03205189

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intense painful experience during hospitalisation

    Time frame: 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.

  2. Low painful experience during hospitalisation

    Time frame: 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.

  3. Low home pain experience

    Time frame: 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

  4. Intense home pain experience

    Time frame: 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.

  5. Low home pain experience

    Time frame: 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

  6. Adherence to analgesic treatment

    Time frame: Within 7 days after ambulatory surgery

    Adherence to analgesic treatment in relation to prescription (yes or not)

  7. Patient's satisfaction

    Time frame: 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)

  8. Use of morphine analgesics

    Time frame: Within 7 days after ambulatory surgery

    Incidence of morphine analgesic use

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: AMBUPRESS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2017
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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