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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004713-91-BE

Enrollment

Registered

2015-01-06

Start date

2015-02-09

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spine Surgery

Interventions

Trade Name: Naropin Pharmaceutical Form: INN or Proposed INN: Ropivacaine CAS Number: 84057-95-4 Other descriptive name: ROPIVACAINE HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/millilitre Co

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 Duration of hospitalisation ;Primary end point(s): Multi modal analgesia in thoracolumbar spine surgery Hospitalisation;Timepoint(s) of evaluation of this end point: The first 3 postoperative days On discharge 1-3-6 and 12 months postoperative	—

Measure

Time frame

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 Duration of hospitalisation ;Primary end point(s): Multi modal analgesia in thoracolumbar spine surgery Hospitalisation;Timepoint(s) of evaluation of this end point: The first 3 postoperative days On discharge 1-3-6 and 12 months postoperative

—

Secondary

Measure	Time frame
Secondary end point(s): Mobilisation Side effects ;Timepoint(s) of evaluation of this end point: The first 3 postoperative days On discharge	—

Countries

Belgium

Contacts

Public ContactDatanurse

Universitair Ziekenhuis Brussel

veerle.vanmossevelde@uzbrussel.be322476 31 34

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026