NCT03454217

Brief Summary

Postoperative pain is usually treated with opioids. Among them, oxycodone is popular in the daily practice as it is administered orally and is easily titrated. However, side-effects include increase duration and frequency of apneic episodes. Some authors believe that tramadol has less impact on these apneic episodes during the first postoperative night, based on a trial that reported conclusive results only during the first 2 postoperative hours. The objective of this randomized controlled trial is to compare the effect of postoperative pain treatment of oxycodone with tramadol on apneic episodes during the first and third postoperative nights.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2018

Typical duration for phase_4

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

First Submitted

Initial submission to the registry

February 27, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

2.6 years

First QC Date

February 27, 2018

Last Update Submit

January 26, 2021

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Apnea hypopnea index while lying supine

    Apnea hypopnea index while lying supine

    Postoperative night 1

Secondary Outcomes (7)

  • Apnea hypopnea index in another position than supine

    Postoperative night 1

  • Mean pulse oxymetry

    Postoperative night 1

  • Apnea hypopnea index while lying supine

    Postoperative night 3

  • Apnea hypopnea index in another position than supine

    Postoperative night 3

  • Mean pulse oxymetry

    Postoperative night 3

  • +2 more secondary outcomes

Study Arms (2)

Oxycodone

ACTIVE COMPARATOR

Postoperative pain treatment with oxycodone

Drug: Oxycodone

Tramadol

ACTIVE COMPARATOR

Postoperative pain treatment with tramadol

Drug: Tramadol

Interventions

OxycodoneDRUG

Postoperative pain treatment with oxycodone

Oxycodone
TramadolDRUG

Postoperative pain treatment with tramadol

Tramadol

Eligibility Criteria

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

You may qualify if:

  • patients scheduled for orthopaedic surgery on the lower limb under a spinal anaesthesia
  • physical status I-III

You may not qualify if:

  • planned surgical duration more than 3 hours
  • contraindication to spinal anaesthesia
  • severe respiratory disease
  • patient treated for sleep apnea syndrome
  • allergy to tramadol or oxycodone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • Albrecht E, Pereira P, Bayon V, Berger M, Wegrzyn J, Antoniadis A, Heinzer R. The Relationship Between Postoperative Opioid Analgesia and Sleep Apnea Severity in Patients Undergoing Hip Arthroplasty: A Randomized, Controlled, Triple-Blinded Trial. Nat Sci Sleep. 2022 Feb 25;14:303-310. doi: 10.2147/NSS.S348834. eCollection 2022.

    PMID: 35241942DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

OxycodoneTramadol

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Eric Albrecht

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program director of regional anaesthesia

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 5, 2018

Study Start

March 1, 2018

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

IPD will be shared upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

CH(1)