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TerminatedNCT03454191Updated Aug 22, 2024

Efficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy

An interventional study of Erector spinae plane block and No injection in Pain, Postoperative, sponsored by Eric Albrecht. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.

Sponsored by Eric Albrecht · Not applicable, Interventional, and Treatment

Why this study was terminated
Recruitment stopped due to lack of research assistant
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pain, Postoperative

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients scheduled for thoracoscopy
  • physical status I-III

Exclusion criteria

Exclusion Criteria:

  • allergy to local anaesthetics
  • other contraindications to peripheral nerve blocks
  • patients suffering from chronic pain condition
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Erector spinae plane block

    Procedure: Erector spinae plane block

  • Placebo comparator
    Placebo

    Procedure: No injection

Interventions

  • ProcedureErector spinae plane block

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

  • ProcedureNo injection

    No injection

05

What researchers measure

Primary outcomes

  1. IV morphine consumption

    mg

    Time frame: 24 postoperative hours

Secondary outcomes

  1. IV morphine consumption

    mg

    Time frame: 2 postoperative hours

  2. IV morphine consumption

    mg

    Time frame: 48 postoperative hours

  3. Pain scores

    Visual analog scale, 0-10

    Time frame: 2, 24, 24 postoperative hours

  4. Chronic pain scores

    Visual analog scale, 0-10

    Time frame: 3 and 6 postoperative months

  5. Forced vital capacity

    L

    Time frame: 24 and 48 postoperative hours

06

Study locations

1 site
  • Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
    Lausanne, Vaud 1011, Switzerland
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03454191
Lead sponsor
Eric Albrecht
Responsible party
Eric Albrecht (Program director of regional anaesthesia, Centre Hospitalier Universitaire Vaudois) — Sponsor-investigator
First posted
Mar 5, 2018
Start date
Feb 1, 2018
Primary completion
Oct 1, 2023
Completion
Oct 1, 2023
Last update
Aug 22, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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