Epidural ropivacaine as part of a multimodal postoperative pain treatment following thoracolumbar spinal fusion surgery.

Phase 1

Active, not recruiting

Conditions: Spine Surgery
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-004713-91-BE

Lead Sponsor: niversitair Ziekenhuis Brussel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Adults: 18 years or older.
posterior spinal thoracic or lumbar fusion.
Subjects witch American Society of Anaesthesiologists physical status classification (ASA) I, II of III.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Minors: younger than 18 years.
Subjects unable to provide informed consent.
Subject with an allergy for the used products.
All subjects categorized as ASA IV or V.
Pregnant Women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The goal of this study is to determine if infusion with ropivacaine at a rate of 7 mL/h is an effective additional treatment for postoperative pain after thoracolumbar spinal fusion surgery. ;Secondary Objective: Mobilisation <br>Duration of hospitalisation <br>;Primary end point(s): Multi modal analgesia in thoracolumbar spine surgery <br>Hospitalisation;Timepoint(s) of evaluation of this end point: The first 3 postoperative days <br>On discharge<br>1-3-6 and 12 months postoperative

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Mobilisation<br>Side effects ;Timepoint(s) of evaluation of this end point: The first 3 postoperative days <br>On discharge<br>