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Comparison of duration of efficient analgesia after painful surgical repair od foot fractures between groups treated with sciatic nerve block alone and sciatic nerve block simultaneously with i.m. tramadol
A randomized, double-blinded study in patients scheduled for surgical repair of foot fractures in spinal anaesthesia where two pain treatment modalities would be compared. One group receives sciatic nerve block with standardized dosis od bupivacaine under ultrasound visualisation, while the other group receives the same block but with simultaneous i.m. injection of tramadol (also standardized). Both the patient and the anaesthesist are blinded, i.e. the control group receives simultaneously with the block a 0,9% sodium hydrochloride injected. Drug or control syringes do not differ, and would be prepared directly before in a randomised, blinded manner by trained co-investigator. Both group receive also the same standardised systemic analgetics with no further use of tramadol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients randomized to receive 0,9% sodium hydrochloride solution 5ml i.m. (gluteus muscle) after spinal anesthesia, simultaneously with the sciatic nerve block. |
|
| Tramadol | Experimental | Patients randomized to receive 100mg of Tramadol hydrochloride in 5ml 0,9% sodium hydrochloride i.m. (gluteus muscle) after spinal anesthesia, simultaneously with the sciatic nerve block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol Hydrochloride | Drug | Tramadol i.m. simultaneous with sciatic nerve block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall analgesic in 24h | Overall Morphine hydrochloride dose in the first 24h after intervention | 24hour |
| Measure | Description | Time Frame |
|---|---|---|
| Time to block resolution | Time from the intervention to complete motoric block resolution | 24hour |
| Time to first analgesic | Time from the intervention (sciatic nerve block/i.m.drug) to the first bolus of Morphine hydrochloride |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janusz Trzebicki, Dr hab. | Medical University of Warsaw | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept.of Anesthesia and Intensive Care, Warsaw Medical University | Warsaw | Masovian Voivodeship | 02-005 | Poland |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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Randomized, double blinded two-arm parallel assignment
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Trained care provider (nurse) prepares the active drug or placebo directly before the procedure according to randomisation list (secured).
| Placebo | Drug | 0,9%NaCl i.m. simultaneous with sciatic nerve block |
|
|
| 24hour |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |