Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis (TramIsch)

October 27, 2021 updated by: Medical University of Warsaw

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-005
        • Dept.of Anesthesia and Intensive Care, Warsaw Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Tramadol i.m.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall analgesic in 24h
Time Frame: 24hour
Overall Morphine hydrochloride dose in the first 24h after intervention
24hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to block resolution
Time Frame: 24hour
Time from the intervention to complete motoric block resolution
24hour
Time to first analgesic
Time Frame: 24hour
Time from the intervention (sciatic nerve block/i.m.drug) to the first bolus of Morphine hydrochloride
24hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Study Chair: Janusz Trzebicki, Dr hab., Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 15, 2017

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ACTUAL)

December 30, 2020

Study Registration Dates

First Submitted

March 19, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (ACTUAL)

March 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WNOZA/1/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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