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Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis

NCT ID: NCT03477851

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2020-12-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Foot Fracture Pain, Acute

Keywords

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sciatic nerve block tramadol foot fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double blinded two-arm parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers
Trained care provider (nurse) prepares the active drug or placebo directly before the procedure according to randomisation list (secured).

Study Groups

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Placebo

Patients randomized to receive 0,9% sodium hydrochloride solution 5ml i.m. (gluteus muscle) after spinal anesthesia, simultaneously with the sciatic nerve block.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Tramadol Hydrochloride

Intervention Type DRUG

Tramadol i.m. simultaneous with sciatic nerve block

Interventions

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Tramadol Hydrochloride

Tramadol i.m. simultaneous with sciatic nerve block

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Tramadol i.m. 0,9%NaCl i.m.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janusz Trzebicki, Dr hab.

Role: STUDY_CHAIR

Medical University of Warsaw

Locations

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Dept.of Anesthesia and Intensive Care, Warsaw Medical University

Warsaw, Masovian Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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WNOZA/1/2017

Identifier Type: -

Identifier Source: org_study_id