Impact of Tramadol and Oxycodone on Sleep Apnea

NCT ID: NCT03454217

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oxycodone

Postoperative pain treatment with oxycodone

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

Postoperative pain treatment with oxycodone

Tramadol

Postoperative pain treatment with tramadol

Group Type ACTIVE_COMPARATOR

Tramadol

Intervention Type DRUG

Postoperative pain treatment with tramadol

Interventions

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Oxycodone

Postoperative pain treatment with oxycodone

Intervention Type DRUG

Tramadol

Postoperative pain treatment with tramadol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Eric Albrecht

Program director of regional anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Albrecht

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Locations

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Lausanne University Hospital

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 35241942 (View on PubMed)

Other Identifiers

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CER 2017-01976

Identifier Type: -

Identifier Source: org_study_id

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