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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
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

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

Condition or disease Intervention/treatment Phase
Foot Fracture Pain, Acute Drug: Tramadol Hydrochloride Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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).
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Placebo
0,9%NaCl i.m. simultaneous with sciatic nerve block
Other Name: 0,9%NaCl i.m.

Experimental: Tramadol
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.




Primary Outcome Measures :
  1. Overall analgesic in 24h [ Time Frame: 24hour ]
    Overall Morphine hydrochloride dose in the first 24h after intervention


Secondary Outcome Measures :
  1. Time to block resolution [ Time Frame: 24hour ]
    Time from the intervention to complete motoric block resolution

  2. Time to first analgesic [ Time Frame: 24hour ]
    Time from the intervention (sciatic nerve block/i.m.drug) to the first bolus of Morphine hydrochloride



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Grzegorz Górniewski, Dr +48225021724 grzegorz.gorniewski@wum.edu.pl
Contact: Marek Janiak, Dr +48225021724 mjaniak8@gmail.com

Locations
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Poland
Dept.of Anesthesia and Intensive Care, Warsaw Medical University Recruiting
Warsaw, Mazowieckie, Poland, 02-005
Contact: Grzegorz Górniewski, Dr    +48225021724    grzegorz.gorniewski@wum.edu.pl   
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Study Chair: Janusz Trzebicki, Dr hab. Medical University of Warsaw

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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03477851     History of Changes
Other Study ID Numbers: WNOZA/1/2017
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical University of Warsaw:
sciatic nerve block
tramadol
foot fracture

Additional relevant MeSH terms:
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Tramadol
Acute Pain
Fractures, Bone
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents