Spinal Morphine for Patients With Obstructive Sleep Apnea
Sleutelwoorden
Abstract
Omschrijving
Total hip and knee arthroplasty (THA and TKA) are among the most common orthopedic procedures performed worldwide1. They have been shown to reduce chronic pain, increase the ability to function independently, and improve quality of life2,3. With an aging and increasingly obese North American population, the uses of THA and TKA are increasing 4. One of the main challenges associated with THA as well as TKA continues to be the perioperative management of patients who are elderly or obese, and their associated co-morbidities. Both THA and TKA are commonly performed under neuraxial anesthesia. Neuraxial anesthesia has been reported to provide multiple benefits when compared to general anesthesia and/or systemic analgesia including superior post-operative analgesia5, reduced opioid consumption6, improved rehabilitation7, and reduced morbidity and mortality8-12. The addition of opioids to the neuraxial local anesthetic solution has been common practice since 1979, when morphine was first shown to provide effective and prolonged analgesia after intrathecal administration13. For both THA and TKA surgeries, intrathecal morphine provides effective analgesia14-16 allowing for a reduction of the dose of intrathecal local anesthetic (thus minimizing side effects)17, and has a marked postoperative opioid-sparing effect14-16. However, these benefits of intrathecal morphine must be weighed against its risks of pruritis, nausea/vomiting, urinary retention, and, of most concern, respiratory depression18.
Datums
| Laatst geverifieerd: | 02/28/2019 |
| Eerste ingediend: | 02/10/2013 |
| Geschatte inschrijving ingediend: | 02/10/2013 |
| Eerst geplaatst: | 02/12/2013 |
| Laatste update ingediend: | 03/14/2019 |
| Laatste update geplaatst: | 03/18/2019 |
| Werkelijke startdatum van het onderzoek: | 12/31/2019 |
| Geschatte primaire voltooiingsdatum: | 07/31/2020 |
| Geschatte voltooiingsdatum van het onderzoek: | 07/31/2020 |
Conditie of ziekte
Interventie / behandeling
Drug: Intrathecal morphine
Drug: No Intrathecal morphine
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| Active Comparator: Intrathecal morphine 100μg of morphine will be added to the intrathecal mixture. | Drug: Intrathecal morphine Depending on the randomization schedule, 100μg of morphine will or will not be added to the intrathecal mixture. |
| Active Comparator: No Intrathecal morphine Morphine will not be added to the intrathecal mixture. | Drug: No Intrathecal morphine Depending on the randomization schedule, 100μg of morphine will or will not be added to the intrathecal mixture. |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 18 Years Naar 18 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| Criteria | Inclusion Criteria: 1. Adults, aged 18-85 2. ASA physical status I-III 3. Suspected of having Obstructive Sleep Apnea(OSA) or previously diagnosed with OSA 4. Scheduled to undergo elective primary Total Hip or Knee Arthroplasty Exclusion Criteria: 1. Chronic obstructive pulmonary disease 2. Asthma 3. History of congestive heart failure 4. Valvular disease 5. Dilated cardiomyopathy 6. Implanted pacemaker or defibrillator 7. Diagnosed OSA who are undergoing continuous positive airway pressure (CPAP) treatment 8. Contraindications to spinal anesthesia 9. Contraindications to a component of multi-modal analgesia 10. Local anesthetic allergy 11. Anticipated surgical duration > 2.5hrs 12. Opioid tolerance (>250mg/24hr oral morphine equivalent pre-operatively) 13. Pregnancy 14. History of significant cognitive or psychiatric condition that may affect patient assessment, or 15. Inability to provide informed consent. 16. Participation in other clinical studies |
Resultaat
Primaire uitkomstmaten
1. Average Oxygen Desaturation Index (ODI) for the first 72 hours postoperatively. [72 hours]
