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NCT Number: NCT04538235

Analgesic Non Inferiority of the Thoracic Bi-block in Comparison With Thoracic Epidural for VATS.

Video-Assisted thoracic surgery (VATS) is the standard treatment for localized lung cancer. However, there is no consensus on analgesic management in patients undergoing VATS.

The aim of the study is to compare the analgesic efficacy of thoracic epidural with that a "Bi-block" combining an Erector Spinae muscle plane Block (ESP) and a Serratus Anterior Block (SAP) in patients undergoing VATS for lung or pleural surgery.

Our main hypothesis is that the analgesic efficacy of the Bi-block, assessed by morphine consumption, is not inferior to that provided by a thoracic epidural during the first 48 hours after VATS. We conducted a age, gender and type of surgery-matched retrospective cohort study in the Department of Thoracic Anesthesia of the Montpellier University Hospital (France).

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Key information

Conditions

Erector Spinae Muscle Plane Block Agnosia Analgesia Enhanced Recovery After Surgery Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Pleural Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Serratus Anterior Muscle Plane Block Signs and Symptoms Thoracic Epidural Thoracic Neoplasms Video-Assisted Thoracic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive Care Unit, D - University hospital of Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • To be over 18.
  • To be scheduled for VATS in the center of the study during the study period.
  • Thoracic Epidural analgesia of Bi-block analgesia.

Exclusion criteria

  • Chronic pain or opioid use before surgery (6 months).
  • Postoperative hospitalization in ICU during the first two days.
  • Postoperative surgical complication needing surgical revision during the first two days.
  • Preoperative dementia or other psychiatric disease incompatible with VAS pain scoring.

Treatment and study plan

Thoracic Regional Analgesia

Procedure

In the TEA group, a thoracic epidural was performed before VATS. In the Bi-block group, a SAP block associated with an ESP block were performed before surgical incision under general anesthesia.

Other names: Thoracic Epidural Analgesia, Bi-block, a regional anesthesia technique combining a serratus anterior block with an erector spinae block

Primary outcomes

  1. cumulative morphine consumption on postoperative day 2

    Time frame: postoperative day 2

    cumulative morphine consumption on postoperative day 2, including the morphine administered in Post anesthesia care unit (PACU), on postoperative day 0, 1 and 2.

Secondary outcomes

  1. non-opioid analgesics consumption on postoperative day 2

    Time frame: postoperative day 2

    Paracetamol, Tramadol, Ketoprofen, Nefopam cumulative consumption on POD 2.

  2. Pain assessed by visual analog pain scale (VAS)

    Time frame: up to postoperative day 2

    mean VAS, maximal VAS, number of events with a VAS > 3

  3. Urinary retention

    Time frame: up to postoperative day 2

  4. hypotension

    Time frame: up to postoperative day 2

  5. pleural drain duration

    Time frame: up to postoperative day 2

  6. duration of hospitalization

    Time frame: up to postoperative day 2

  7. occurrence of prurit

    Time frame: up to postoperative day 2

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Analgesic Non Inferiority of the Thoracic Bi-block Combining an Erector Spinae Muscle Plane Block and a Serratus Anterior Muscle Plane Block in Comparison With Thoracic Epidural for Video-Assisted Thoracic Surgery.

Acronym: ANESSTEVATS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 4, 2020
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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