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The study aims to assess the effect of spinal anaesthesia against a general anaesthesia with a femoral block, with respect to the incidence of chronic pain following a total knee replacement.
It will also focus on genetic factors and their influence on chronic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Anaesthesia | Active Comparator | Patients will receive a general anaesthetic, together with a femoral nerve block. |
|
| Spinal Anaesthesia | Active Comparator | Patients will receive a spinal anaesthetic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal anaesthesia | Procedure | Patients will receive a spinal anaesthetic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Numerical Rating Scale on physiotherapy | Pain Numerical Rating Scale, from 0 (no pain) to 10 (severe pain) | 24 hours |
| WOMAC Score at 3 and at 6 months | WOMAC score, ranging from 0 to 94 | 6 months |
| WOMAC Pain Score at 3 and at 6 months | WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption | Morphine use postop | 24 hours |
| Pain Numerical Rating Scale after 6 months | Pain Numerical Rating Scale at rest, from 0 (no pain) to 10 (severe pain) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mater Dei Hospital | Msida | MSD2090 | Malta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35350864 | Derived | Sciberras SC, Vella AP, Vella B, Spiteri J, Mizzi C, Borg-Xuereb K, LaFerla G, Grech G, Sammut F. A randomized, controlled trial on the effect of anesthesia on chronic pain after total knee arthroplasty. Pain Manag. 2022 Sep;12(6):711-723. doi: 10.2217/pmt-2021-0081. Epub 2022 Mar 30. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2018 |
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| General anaesthesia |
| Procedure |
patients will receive a general anaesthetic and a femoral nerve block |
|
| 6 months |
| Incidence of Chronic Post-surgical Pain | WOMAC pain score greater than 5 at 6 months (out of total of 20) | 6 months |
| Change in WOMAC Score at 3 and at 6 months | change in WOMAC score, ranging from 0 to 94 | 6 months |
| Change in WOMAC Pain Score at 3 and at 6 months | change in WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities) | 6 months |
| Dec 17, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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