search
Back to results

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

Primary Purpose

Foot Fracture, Pain, Acute

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Tramadol Hydrochloride
Placebo
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Fracture focused on measuring sciatic nerve block, tramadol, foot fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept.of Anesthesia and Intensive Care, Warsaw Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Tramadol

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Overall analgesic in 24h
Overall Morphine hydrochloride dose in the first 24h after intervention

Secondary Outcome Measures

Time to block resolution
Time from the intervention to complete motoric block resolution
Time to first analgesic
Time from the intervention (sciatic nerve block/i.m.drug) to the first bolus of Morphine hydrochloride

Full Information

First Posted
March 19, 2018
Last Updated
October 27, 2021
Sponsor
Medical University of Warsaw
search

1. Study Identification

Unique Protocol Identification Number
NCT03477851
Brief Title
Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis
Acronym
TramIsch
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Fracture, Pain, Acute
Keywords
sciatic nerve block, tramadol, foot fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double blinded two-arm parallel assignment
Masking
Care Provider
Masking Description
Trained care provider (nurse) prepares the active drug or placebo directly before the procedure according to randomisation list (secured).
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients randomized to receive 0,9% sodium hydrochloride solution 5ml i.m. (gluteus muscle) after spinal anesthesia, simultaneously with the sciatic nerve block.
Arm Title
Tramadol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tramadol Hydrochloride
Other Intervention Name(s)
Tramadol i.m.
Intervention Description
Tramadol i.m. simultaneous with sciatic nerve block
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0,9%NaCl i.m.
Intervention Description
0,9%NaCl i.m. simultaneous with sciatic nerve block
Primary Outcome Measure Information:
Title
Overall analgesic in 24h
Description
Overall Morphine hydrochloride dose in the first 24h after intervention
Time Frame
24hour
Secondary Outcome Measure Information:
Title
Time to block resolution
Description
Time from the intervention to complete motoric block resolution
Time Frame
24hour
Title
Time to first analgesic
Description
Time from the intervention (sciatic nerve block/i.m.drug) to the first bolus of Morphine hydrochloride
Time Frame
24hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janusz Trzebicki, Dr hab.
Organizational Affiliation
Medical University of Warsaw
Official's Role
Study Chair
Facility Information:
Facility Name
Dept.of Anesthesia and Intensive Care, Warsaw Medical University
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-005
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis

We'll reach out to this number within 24 hrs