Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Evaluation of the Influence of Tramadol Injection Simultaneous With Sciatic Nerve Block on the Duration of Efficient Sensory Blockade in Patients Operated on for Calcaneus Fracture

Conditions
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Foot Fracture, Pain, Acute

Intervention / Treatment
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* Drug: Tramadol Hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with foot fracture scheduled for surgical repair in spinal anesthesia Informed consent Exclusion Criteria: No consent Spinal anesthesia or sciatic nerve block contraindicated Known intolerance to tramadol or other contraindications for the drug

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double blinded two-arm parallel assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients randomized to receive 0,9% sodium hydrochloride solution 5ml i.m. (gluteus muscle) after spinal anesthesia, simultaneously with the sciatic nerve block. | Drug: Placebo<br>* 0,9%NaCl i.m. simultaneous with sciatic nerve block<br>* Other names: 0,9%NaCl i.m.;|
| Experimental: Tramadol<br>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. | Drug: Tramadol Hydrochloride<br>* Tramadol i.m. simultaneous with sciatic nerve block<br>* Other names: Tramadol i.m.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall analgesic in 24h | Overall Morphine hydrochloride dose in the first 24h after intervention | 24hour | 

Secondary Outcome Measures

| Outcome Measure | 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 | 24hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tramadol, sciatic nerve block, foot fracture