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Double-blinded randomized control study investigating intrathecal morphine as an additive to spinal anesthesia in patients undergoing elective total knee arthroplasty. The investigators aim to include a total of 120 patients, randomized to two equal groups. Participants in the intervention group are administered intrathecal 0,2mg morphine and 12,5mg bupivacaine for spinal anaesthesia. Participants in the placebo group are administered 12.5mg bupivacaine and saline to match the volume of intervention goup. Primary end points are opioid consumption and possible adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal morphine and bupivacaine | Experimental | 0,2mg intrathecal morphine and 12,5mg bupivacaine administered |
|
| Placebo | Active Comparator | 12,5mg bupivacaine and NaCl 0,9% to match the same volume administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Hydrochloride, Spinal | Drug | Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| intravenous oxycodone consumption | Cumulative postoperative consumption | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects of 0,2mg intrathecal morphine | Possible nausea, vomiting, itching and respiratory depression | 48 hours |
| Mobilization time | Assessing the time to ambulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susanna Niinimäki, BSc, SRN /Anesthesia | Contact | +358406511388 | susanna.niinimaki@eksote.fi | |
| Seppo Mustola, MD, PhD | Contact | +358447915832 | seppo.mustola@eksote.fi |
| Name | Affiliation | Role |
|---|---|---|
| Seppo Mustola, MD, PhD | South Carelia Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Carelia Central Hospital | Recruiting | Lappeenranta | 53130 | Finland |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Morphine hydrochloride, Spinal | Drug | Intrathecally administered morphine 0,2mg (2mg/ml, 0,1ml) |
|
| Placebo - Concentrate | Drug | Intrathecally administered saline solution 0,9% 0,1ml to match morphine volume |
|
|
| 48 hours |
| Patient satisfaction | Telephone interview 28 days after surgery | 28 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |