NCT03454191

Brief Summary

The erector spinae plane block has been recently described as an effective analgesic postoperative pain treatment in case reports. It consists of injecting local anaesthetics below the erector spinae muscle, at the level of the transverse processes, in order to anaesthetize the thoracic roots coming out from the spinal cord. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore, the objective of this study is to investigate the analgesic benefit of this block on patients scheduled for thoracoscopy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

5.7 years

First QC Date

February 27, 2018

Last Update Submit

August 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • IV morphine consumption

    mg

    24 postoperative hours

Secondary Outcomes (5)

  • IV morphine consumption

    2 postoperative hours

  • IV morphine consumption

    48 postoperative hours

  • Pain scores

    2, 24, 24 postoperative hours

  • Chronic pain scores

    3 and 6 postoperative months

  • Forced vital capacity

    24 and 48 postoperative hours

Study Arms (2)

Erector spinae plane block

EXPERIMENTAL
Procedure: Erector spinae plane block

Placebo

PLACEBO COMPARATOR
Procedure: No injection

Interventions

Injection of local anaesthetics below the erector spinae muscle after induction of anaesthesia

Erector spinae plane block
No injectionPROCEDURE

No injection

Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for thoracoscopy
  • physical status I-III

You may not qualify if:

  • allergy to local anaesthetics
  • other contraindications to peripheral nerve blocks
  • patients suffering from chronic pain condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Program director of regional anaesthesia

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 5, 2018

Study Start

February 1, 2018

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations