NCT04011501

Brief Summary

Minimally invasive cardiac surgery is performed through a right thoracotomy, the pain management of this surgery is of great importance. Regional techniques such as thoracic epidural anesthesia or paravertebral block are excellent techniques for the management of postoperative pain in thoracic surgery but they have disadvantages that make it difficult to use in this surgery. On the one hand, anticoagulation in these patients increases the risk of complications related to the use of neuraxial techniques and, on the other hand, the technical difficulty of paravertebral block. The erector of the spine block is a technically simple block and with a low risk of associated complications. The aim of the study is to evaluate the feasibility and benefits in the relationship of postoperative pain management in patients undergoing minimally invasive cardiac surgery when using continuous unilateral blockade of the erector in a small cohort of patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

July 2, 2019

Last Update Submit

July 10, 2019

Conditions

Pain, PostoperativeHeart Valve Diseases

Keywords

erector spinae plane blockthoracic surgerycardiac surgical procedurespain, postoperative

Outcome Measures

Primary Outcomes (2)

  • Assesment of postoperative analgesia

    Post operative pain scores will be recorded with a NRS(numerical rating scala) from 0 to 10 ( 0=no pain, 10= pain as bad as can be) worst score at 12 hrs, 24 hrs and 48 hrs period will be scored.

    up to 48 hours

  • Morphine consumption

    total morphine consumption in milligrams at 12 hrs, 24 hrs and 48 hrs will be scored.

    up to 48 hours

Study Arms (1)

Continuous unilateral ESP block

EXPERIMENTAL

Erector spine block and catheter placement will be performed for continuous analgesia on this group of patients undergoing minimally invasive cardiac surgery. Initially a volume of 20 ml of Levobupivacaine 0.25% will be administered and subsequently a 22G catheter will be introduced and fixed 10-12 cm from the skin. At the end of the surgery, an elastomeric pump will be installed at a flow rate of 7 ml / hr with a 1.3% Ropivacaine solution.

Procedure: Continuous Erector spinae block

Interventions

Continuous Erector spinae blockPROCEDURE

Erector spine block and catheter placement will be performed for continuous analgesia prior to the surgical procedure.A initial bolus of 20 ml of Levobupivacaine 0.25% will be administered. Subsequently a 22G catheter will be introduced. At the end of the surgery, an elastomeric pump will be installed at a flow rate of 7 ml / hr with a 1.3% Ropivacaine solution.

Continuous unilateral ESP block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects undergoing minimally invasive cardiac surgery
  • Acceptance to participate in the study
  • ASA physical status II-IV
  • Age \> 18 years

You may not qualify if:

  • Refusal to participate in the study
  • Allergy to local anesthetics
  • History of substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, 0836, Spain

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeHeart Valve Diseases

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Xavier Sala-Blanch, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Sala-Blanch, MD

CONTACT

346263536009xavi.sala.blanch@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 8, 2019

Study Start

May 7, 2019

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

July 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)