Erector Spinae plane block for minimal invasive mitral valve surgery. A double blind, prospective randomized placebo-controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001125-27-BE

Enrollment

Registered

2019-04-29

Start date

2019-06-04

Completion date

Unknown

Last updated

2022-01-24

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

Conditions

postoperative pain

Interventions

Trade Name: naropin Pharmaceutical Form: Solution for injection INN or Proposed INN: ropivacain CAS Number: 132112-35-7 Other descriptive name: ROPIVACAINE HYDROCHLORIDE MONOHYDRATE Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 18-75 years of age BMI =65 years) yes F.1.3.1 Number of subjects for this age range 27

Exclusion criteria

Exclusion criteria: Patient refusal inability to operate a PCA system planned admission to Intensice Care Unit Chronic opioid use Obstructive sleep apnea syndrome epilepsy

Design outcomes

Primary

Measure	Time frame
Main Objective: The goal of this study is to improve pain management after minimal invasive mitral valve surgery and to facilitate postoperative recovery. Our hypothesis is that patients having an Erector Spinae Block via intermittent boli ropivacain via catheter is associated with a reduction in postoperative morphine consumption.;Secondary Objective: Not applicable;Primary end point(s): cumulative 24-hour morphine consumption post-extubation;Timepoint(s) of evaluation of this end point: 24 hours after extubation	—

Measure

Time frame

Main Objective: The goal of this study is to improve pain management after minimal invasive mitral valve surgery and to facilitate postoperative recovery. Our hypothesis is that patients having an Erector Spinae Block via intermittent boli ropivacain via catheter is associated with a reduction in postoperative morphine consumption.;Secondary Objective: Not applicable;Primary end point(s): cumulative 24-hour morphine consumption post-extubation;Timepoint(s) of evaluation of this end point: 24 hours after extubation

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Secondary

Measure	Time frame
Secondary end point(s): Pain intensity as assessed with the numerical rating score for pain Requested dosage morphine IV PCA Extent of sensory block Incidence of adverse events during treatment Early safety endpoints as defined by VARC-2 Consumption of co-analgesic drugs;Timepoint(s) of evaluation of this end point: NRS pain: every 15 min following extubation until + 120 min; 6h - 12h - 18h- 24h after extubation Extent of sensory block at extubation, 2h-18h after extubation Morphine IV PCA consumption: 24 hours after start of PCA Incidence of adverse events: continuously until 24h after extubation	—

Measure

Time frame

Secondary end point(s): Pain intensity as assessed with the numerical rating score for pain Requested dosage morphine IV PCA Extent of sensory block Incidence of adverse events during treatment Early safety endpoints as defined by VARC-2 Consumption of co-analgesic drugs;Timepoint(s) of evaluation of this end point: NRS pain: every 15 min following extubation until + 120 min; 6h - 12h - 18h- 24h after extubation Extent of sensory block at extubation, 2h-18h after extubation Morphine IV PCA consumption: 24 hours after start of PCA Incidence of adverse events: continuously until 24h after extubation

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Countries

Belgium

Contacts

Public ContactAnesthesiology Research

University Hospitals Leuven

christel.huygens@uzleuven.be003216344270

Outcome results

None listed

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