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| Name | Class |
|---|---|
| Kehlet, Henrik, M.D., Ph.D. | INDIV |
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Incidence of orthostatic intolerance and orthostatic hypotension after intravenous administration of morphine in patients prior to hip or knee arthroplasty.
Early postoperative mobilization is crucial for recovery of patients undergoing surgery in the multimodal fast-track approach to perioperative care, since physical immobilization is highly associated with increased risk of postoperative complications and prolonged hospital length of stay. Postoperative mobilization is often delayed due to patients experiencing orthostatic hypotension (OH), defined as a drop in systolic blood pressure > 20 mmHg or diastolic blood pressure > 10 mmHg, or orthostatic intolerance (OI), characterized by dizziness, blurred vision, nausea, vomiting, sensation of heat or syncope.
Previous studies have found a high incidence of postoperative OI (> 40 %) among patients undergoing total hip arthroplasty.
A possible causative factor to the high occurrence of OH and OI after surgery could be postoperative pain management by administration of morphine. Morphine is known to have many side-effects including nausea, vomiting, dizziness and orthostatic hypotension.
The object of this study is to isolate and estimate the effect of intravenous morphine on the incidence of OH and OI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing primary hip or knee arthroplasty | Patients undergoing primary hip or knee arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine | Drug | Administration of 0.1 mg/kg (IBW) intravenous morphine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of orthostatic hypotension | Orthostatic hypotension is defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg during mobilization | 30 minutes after morphine administration |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in systolic arterial pressure (SAP) during mobilization | Measured in mmHg by non-invasive Lithium Dilution Cardiac Output (LiDCO) measurement | Before and 30 minutes after morphine administration |
| Changes in diastolic arterial pressure (DAP) during mobilization |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score during mobilisation | Measured by verbal rating scale (VRS) from 0 to 10 (0 = no pain, 10 = worse pain imaginable) | Before and 30 minutes after morphine administration |
| Occurence of side-effects to morphine administration |
Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing primary unilateral total hip arthroplasty, total knee arthroplasty or unicompartmental knee arthroplasty
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bodil Uldall-Hansen, BA Medicine | Contact | +4528342057 | bodil.uldall-hansen@regionh.dk | |
| Ana-Marija Hristovska, Resident | Contact | +4538621508 | anamarijahristovska@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nicolai Bang Foss, Dr. Med. | Copenhagen University Hospital, Hvidovre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre University Hospital | Recruiting | Hvidovre | 2960 | Denmark |
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| ID | Term |
|---|---|
| D007024 | Hypotension, Orthostatic |
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007022 | Hypotension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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Measured in mmHg by non-invasive LiDCO |
| Before and 30 minutes after morphine administration |
| Changes in mean arterial pressure (MAP) during mobilization | Measured in mmHg by non-invasive LiDCO | Before and 30 minutes after morphine administration |
| Changes in heart rate (HR) during mobilization | Measured in beats min-1 by non-invasive LiDCO | Before and 30 minutes after morphine administration |
| Changes in stroke volume (SV) during mobilization | Measured in mL by non-invasive LiDCO | Before and 30 minutes after morphine administration |
| Changes in cardiac output (CO) during mobilization | Measured in L/min by non-invasive LiDCO | Before and 30 minutes after morphine administration |
| Changes in systemic vascular resistance (SVR) during mobilization | Measured in dynes s cm-5 by non-invasive LiDCO | Before and 30 minutes after morphine administration |
| Changes in peripheral perfusion index (PPI) during mobilization | Measured in % by Root Masimo | Before and 30 minutes after morphine administration |
| Changes in cerebral perfusion (ScO2) during mobilization | Measured in % by Root Masimo | Before and 30 minutes after morphine administration |
| Changes in muscular perfusion (SmO2) during mobilization | Measured in % by Root Masimo | Before and 30 minutes after morphine administration |
| Changes in baroreflex sensitivity - vagal (BRSv) during Valsalva manoeuvre | Measured in ms | Before and 30 minutes after morphine administration |
| Changes in heart rate variability (HRV) during Valsalva manoeuvre | Measured in ms | Before and 30 minutes after morphine administration |
Occurrence of following side-effects to morphine administration: nausea, vomiting, pruritus, headache or dizziness
| 30 minutes after morphine administration |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |