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Completed

NCT Number: NCT03477851

Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis

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

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Key information

Conditions

Foot Fracture Acute Pain Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept.of Anesthesia and Intensive Care, Warsaw Medical University

Warsaw, Masovian Voivodeship, 02-005, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol Hydrochloride

Drug

Tramadol i.m. simultaneous with sciatic nerve block

Other names: Tramadol i.m.

Placebo

Drug

0,9%NaCl i.m. simultaneous with sciatic nerve block

Other names: 0,9%NaCl i.m.

Primary outcomes

  1. Overall analgesic in 24h

    Time frame: 24hour

    Overall Morphine hydrochloride dose in the first 24h after intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study 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

Acronym: TramIsch

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2018
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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