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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine with normal saline | Placebo Comparator |
| |
| Bupivacaine with intrathecal morphine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine with normal saline | Drug | Isobaric bupivacaine 15 mg + normal saline 0.5 cc |
|
| Measure | Description | Time Frame |
|---|---|---|
| apnea hypopnea index while lying supine | postoperative night 0 |
| Measure | Description | Time Frame |
|---|---|---|
| apnea hypopnea index while lying in another position than supine | postoperative night 0 | |
| mean pulse oxymetry | postoperative night 0 | |
| STOP-BANG questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Albrecht, MD | University of Lausanne Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lausanne University Hospital | Lausanne | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38862381 | Derived | Albrecht E, Wegrzyn J, Rossel JB, Bayon V, Heinzer R. Impact of spinal versus general anaesthesia on perioperative obstructive sleep apnoea severity in patients undergoing hip arthroplasty: a post hoc analysis of two randomised controlled trials. Br J Anaesth. 2024 Aug;133(2):416-423. doi: 10.1016/j.bja.2024.04.051. Epub 2024 Jun 10. | |
| 32900508 |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine with intrathecal morphine | Drug | Isobaric bupivacaine 15 mg + intrathecal morphine 100 mcg |
|
| 24 h before surgery |
| Berlin questionnaire | 24 h before surgery |
| Epworth questionnaire | 24 h before surgery |
| pain scores (numeric rating scale, 0-10) | postoperative day 0, 1, 2 and 3 |
| oxycodone consumption (mg) | postoperative day 0, 1, 2 and 3 |
| postoperative nausea and vomiting (yes/no) | postoperative day 0, 1, 2 and 3 |
| Pruritus (yes/no) | postoperative day 0, 1, 2 and 3 |
| Albrecht E, Bayon V, Hirotsu C, Al Ja'bari A, Heinzer R. Intrathecal morphine and sleep apnoea severity in patients undergoing hip arthroplasty: a randomised, controlled, triple-blinded trial. Br J Anaesth. 2020 Nov;125(5):811-817. doi: 10.1016/j.bja.2020.07.052. Epub 2020 Sep 6. |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |