NCT03205189

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started May 2017

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

June 15, 2017

Last Update Submit

February 27, 2026

Conditions

Postoperative ComplicationPostoperative PainAmbulatory SurgeryAnesthesia

Keywords

postoperative painambulatory surgerygeneral anesthesiaanesthesia consultationpost-op prescription

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours after ambulatory surgery

Secondary Outcomes (8)

  • Intense painful experience during hospitalisation

    Day 1

  • Low painful experience during hospitalisation

    Day 1

  • Low home pain experience

    24 hours after ambulatory surgery

  • Intense home pain experience

    Within 7 days after ambulatory surgery

  • Low home pain experience

    Within 7 days after ambulatory surgery

  • +3 more secondary outcomes

Study Arms (2)

Pre-operative prescription group

OTHER

This group will have a pre-operative prescription delivered during the preoperative anesthesia clinic.

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

Postoperative prescription group

OTHER

This group will receive the postoperative prescription.

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

Interventions

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.

Postoperative prescription groupPre-operative prescription group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any major ambulatory surgery patient with general anesthesia.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

Related Publications (1)

  • 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: 33982238DERIVED

MeSH Terms

Conditions

Pain, PostoperativePostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Vincent COMPERE, Pr

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a randomized, prospective, study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2017

First Posted

July 2, 2017

Study Start

May 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)