Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis

NCT03477851 | Completed Phase 4

• 1 other identifier: WNOZA/1/2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Foot Fracture; Pain, Acute

Keywords

sciatic nerve block; tramadol; foot fracture

Outcome Measures

Primary Outcomes (1)

• Overall analgesic in 24h

  Overall Morphine hydrochloride dose in the first 24h after intervention

  24hour

Secondary Outcomes (2)

• Time to block resolution

  24hour

• Time to first analgesic

  24hour

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Tramadol

EXPERIMENTAL

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

Interventions

Tramadol Hydrochloride DRUG

Tramadol i.m. simultaneous with sciatic nerve block

Also known as: Tramadol i.m.

Tramadol

Placebo DRUG

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

Also known as: 0,9%NaCl i.m.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with foot fracture scheduled for surgical repair in spinal anesthesia
• Informed consent

You may not qualify if:

• No consent
• Spinal anesthesia or sciatic nerve block contraindicated
• Known intolerance to tramadol or other contraindications for the drug

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Dept.of Anesthesia and Intensive Care, Warsaw Medical University

Warsaw, Masovian Voivodeship, 02-005, Poland

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Janusz Trzebicki, Dr hab.

  Medical University of Warsaw

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Trained care provider (nurse) prepares the active drug or placebo directly before the procedure according to randomisation list (secured).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double blinded two-arm parallel assignment

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 26, 2018
• Study Start: June 15, 2017
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: October 28, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)