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NCT Number: NCT04983836

Comparison of Analgesic Efficiency Between Serratus Block and Paravertebral Block in Video-assisted Thoracic Surgery. Double-blind Randomized Comparative Non-inferiority Study (BSBP)

Currently, the 2 main techniques of regional loco anesthesia in perioperative analgesic management of the thoracotomy remains the establishment of a thoracic epidural or paravertebral block. On the other hand, there is no standard of perioperative analgesic management in the case of thoracic surgery under video-thoracoscopy. The video-thoracoscopy, by its mini-invasive character, makes the levels of pain lower in post-operative questioning the benefit/risk balance of the paravertebral block. In 2013, Blanco published a new technique of locoregional anesthesia called the block Serratus allowing analgesia of a homolateral thorax hemi The latter by its simplicity of realization and its lesser risk is growing in thoracic surgery. This pilot study finds an equivalence in total oxycodone consumption in the first 2 post-operative days with a number of complications related to the serratus block lower than the serratus block compared to the paravertebral block in preoperative surgery.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de NICE

Nice, Toutes, 06000, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years
  • Patient who has given their free, informed and signed consent
  • Social security affiliation;

Exclusion criteria

  • pregnant woman
  • guardianship / curatorship / private patient under public law
  • surgery to be performed urgently (less than 24 hours)
  • surgery redux
  • thoracotomy surgery
  • sternotomy surgery
  • pleurectomy
  • patient participating simultaneously in another research that may interfere with results of the study
  • severe abnormality of haemostasis (80,000/ml platelets) and/or coagulation (TP 50%, factor V 50%).
  • Prior use of morphine;
  • chronic pain/chest neuropathies
  • sepsis
  • patients with insulin-dependent diabetes and/or diabetic neuropathy.
  • severe kidney or liver failure.

Treatment and study plan

Serratus anesthesia technique

Procedure

locoregional anaesthesia allowing analgesia of the hemi-thorax by ultrasound guided single injection of naropeine 5mg/ml

Paravertebral anesthesia technique

Procedure

Ultrasound guided single injection of of naropeine 5mg/ml dose into the paravertebral space next to the thoracic spine

Primary outcomes

  1. Pain evaluation

    Time frame: 48 hours after the surgery

    Assess the non-inferiority of the single-injection echo-guided serratus block, performed in video-thoracic surgery preoperative, on the post-operative mean pain during the first 48 hours, compared to the single-injection echo-guided paravertebral block with a simple numeric scale (from 0 to 10)

Secondary outcomes

  1. Walking test

    Time frame: 24 hours after the surgery

    Improvement of walking distance during the test at 6 min post-operative

  2. Post operative morphine dose Post operative administrated morphin dose

    Time frame: 48 hours after the surgery

    Mesure of intraoperative morphine administrated dose and total morphine administrated dose (in mg).

  3. Morphine side effect quantification

    Time frame: 48 hours after the surgery

    Collection of adverse reactions due to morphine administration (nausea, vomiting, pruritus, urine retention, respiratory depression)

  4. Length of hospitalisation duration

    Time frame: 1 year

    Number of hospitalisation days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Comparison of Analgesic Efficiency Between Serratus Block and Paravertebral Block in Video-assisted Thoracic Surgery. Double-blind Randomized Comparative Non-inferiority Study

Acronym: BSBP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 30, 2021
Registry last updated
Jun 9, 2023

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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