Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis (TramIsch)
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|ClinicalTrials.gov Identifier: NCT03477851|
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : March 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Foot Fracture Pain, Acute||Drug: Tramadol Hydrochloride Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, double blinded two-arm parallel assignment|
|Masking:||Single (Care Provider)|
|Masking Description:||Trained care provider (nurse) prepares the active drug or placebo directly before the procedure according to randomisation list (secured).|
|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|
|Actual Study Start Date :||June 15, 2017|
|Estimated Primary Completion Date :||June 15, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Placebo Comparator: Placebo
Patients randomized to receive 0,9% sodium hydrochloride solution 5ml i.m. (gluteus muscle) after spinal anesthesia, simultaneously with the sciatic nerve block.
0,9%NaCl i.m. simultaneous with sciatic nerve block
Other Name: 0,9%NaCl i.m.
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
Tramadol i.m. simultaneous with sciatic nerve block
Other Name: Tramadol i.m.
- Overall analgesic in 24h [ Time Frame: 24hour ]Overall Morphine hydrochloride dose in the first 24h after intervention
- Time to block resolution [ Time Frame: 24hour ]Time from the intervention to complete motoric block resolution
- Time to first analgesic [ Time Frame: 24hour ]Time from the intervention (sciatic nerve block/i.m.drug) to the first bolus of Morphine hydrochloride
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477851
|Contact: Grzegorz Górniewski, Dremail@example.com|
|Contact: Marek Janiak, Drfirstname.lastname@example.org|
|Dept.of Anesthesia and Intensive Care, Warsaw Medical University||Recruiting|
|Warsaw, Mazowieckie, Poland, 02-005|
|Contact: Grzegorz Górniewski, Dr +48225021724 email@example.com|
|Study Chair:||Janusz Trzebicki, Dr hab.||Medical University of Warsaw|