NCT03477851

Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Foot Fracture
• Pain, Acute

Interventions

Type	Name	Description
DRUG	Tramadol Hydrochloride	Tramadol i.m. simultaneous with sciatic nerve block
DRUG	Placebo	0,9%NaCl i.m. simultaneous with sciatic nerve block

Timeline

• Start date: 2017-06-15
• Primary completion: 2020-06-30
• Completion: 2020-12-30
• First posted: 2018-03-26
• Last updated: 2021-10-28

Locations

1 site across 1 country: Poland