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NCT03477851 Clinical Trial

Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis

Pain, Acute Clinical Trial

— TramIsch  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03477851
Other study ID # WNOZA/1/2017
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 15, 2017
Est. completion date December 30, 2020

Study information
Verified date May 2020
Source Medical University of Warsaw
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tramadol Hydrochloride
Tramadol i.m. simultaneous with sciatic nerve block
• Placebo
0,9%NaCl i.m. simultaneous with sciatic nerve block

Locations
Country Name City State
Poland Dept.of Anesthesia and Intensive Care, Warsaw Medical University Warsaw Mazowieckie

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall analgesic in 24h Overall Morphine hydrochloride dose in the first 24h after intervention 24hour
Secondary Time to block resolution Time from the intervention to complete motoric block resolution 24hour
Secondary Time to first analgesic Time from the intervention (sciatic nerve block/i.m.drug) to the first bolus of Morphine hydrochloride 24hour
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