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Completed

NCT Number: NCT02566226

Impact of Intrathecal Morphine on Sleep Apnea Syndrome

Intrathecal morphine is commonly used as an analgesic adjunct for hip arthroplasty performed under spinal anaesthesia. Sleep apnea syndrome is a condition that affects up to 10% of the patients. Effect of intrathecal hydrophilic opioids on the frequency and duration of apneic episodes is unknown. The objective of this randomised controlled trial is to investigate the effect of intrathecal morphine and surgery on apneic episodes.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lausanne University Hospital

Lausanne, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • physical status I - III
  • patients scheduled to undergo hip arthroplasty

Exclusion criteria

  • planned surgical duration more than 3 hours
  • contraindication to spinal anaesthesia
  • severe respiratory disease
  • patient known and treated for sleep apnea syndrome

Treatment and study plan

Bupivacaine with normal saline

Drug

Isobaric bupivacaine 15 mg + normal saline 0.5 cc

Bupivacaine with intrathecal morphine

Drug

Isobaric bupivacaine 15 mg + intrathecal morphine 100 mcg

Primary outcomes

  1. apnea hypopnea index while lying supine

    Time frame: postoperative night 0

Secondary outcomes

  1. apnea hypopnea index while lying in another position than supine

    Time frame: postoperative night 0

  2. mean pulse oxymetry

    Time frame: postoperative night 0

  3. STOP-BANG questionnaire

    Time frame: 24 h before surgery

  4. Berlin questionnaire

    Time frame: 24 h before surgery

  5. Epworth questionnaire

    Time frame: 24 h before surgery

  6. pain scores (numeric rating scale, 0-10)

    Time frame: postoperative day 0, 1, 2 and 3

  7. oxycodone consumption (mg)

    Time frame: postoperative day 0, 1, 2 and 3

  8. postoperative nausea and vomiting (yes/no)

    Time frame: postoperative day 0, 1, 2 and 3

  9. Pruritus (yes/no)

    Time frame: postoperative day 0, 1, 2 and 3

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

Impact of Intrathecal Morphine on Sleep Apnea Syndrome After Hip Arthroplasty Performed Under Spinal Anaesthesia

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2015
Registry last updated
Nov 4, 2019

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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