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NCT Number: NCT03110120

Interest of Serratus Plane Block in Postoperative Analgesia for Robot-assisted Surgery

The aim of the study is to compare the analgesia provided by the serratus plane block with local infiltration of the orifices of the trocars after thoracic robot-assisted surgery.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Robotic Surgery Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Watremez Christine

Brussels, 1200, Belgium

About this study

In our hospital, the current practice to provide post operative analgesia for patients scheduled for robot-assisted mitral repair or oncological thoracic surgery is to dispense local anesthetics at the orifices of the trocars at the end of the surgery and to give a Patient Controlled Analgesia (PCA). Some of these patients are not comfortable and we observe a large percentage of chronic pain. Recently we tried to use the Serratus plane block realised before the beginning of the surgery, and it seemed that patients were more comfortable with a lower consumption of morphine. So we decided to perform a double blind, randomized study in this population of patients to compare the analgesia provided by the serratus plane block realized before the beginning of the surgery and the local infiltration of the wound at the end of the surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • mitral repair, coronary artery revascularization or thoracic surgery scheduled robot-assisted surgery

Exclusion criteria

  • non robot-assisted surgery

Treatment and study plan

0.5% levobupivacaine injectable solution with 10 ml of physiological saline

Drug

Serratus plane block realized with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline

Other names: serratus plane block

0.5% levobupivacaine injectable solution with physiological saline

Drug

Serratus plane block realized with 20 ml of injectable solution of physiological saline

Other names: local serratus

Primary outcomes

  1. D0 pain intensity

    Time frame: 1 day

    Self reported pain intensity the day of surgery. Each item is scored 0-100 (0 - no pain, 100 - pain as bad as can be)

Secondary outcomes

  1. D1 pain intensity

    Time frame: 3 days

    Self reported pain intensity the days after surgery. Each item is scored 0 - 100 (0 - no pain, 100 - pain as bad as can be)

  2. morphine consumption

    Time frame: 5 days

    Consumption of morphine the day and 4 days after surgery as recorded on the PCA.

  3. persistence of a chronic pain

    Time frame: 3 months

    Phone call 3 month after surgery to evaluate the persistence of pain

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

Interest of Serratus Plane Block in Postoperative Analgesia for Patients Undergoing Robot-assisted Mitral Valve Repair, MIDCAB or Partial Lung Resection

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 12, 2017
Registry last updated
Oct 10, 2017

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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