Foot Fracture, Pain, Acute
Conditions
Keywords
sciatic nerve block, tramadol, foot fracture
Brief summary
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
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.
Interventions
DRUGTramadol Hydrochloride
Tramadol i.m. simultaneous with sciatic nerve block
DRUGPlacebo
0,9%NaCl i.m. simultaneous with sciatic nerve block
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
Trained care provider (nurse) prepares the active drug or placebo directly before the procedure according to randomisation list (secured).
Intervention model description
Randomized, double blinded two-arm parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall analgesic in 24h | 24hour | Overall Morphine hydrochloride dose in the first 24h after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to block resolution | 24hour | Time from the intervention to complete motoric block resolution |
| Time to first analgesic | 24hour | Time from the intervention (sciatic nerve block/i.m.drug) to the first bolus of Morphine hydrochloride |
Countries
Poland
Outcome results
None listed