Serratus Anterior Plane Block: Post-operative Analgesia in Video-assisted Thoracic Surgery (Serrathos)

September 6, 2017 updated by: Paul Gruson, Université Libre de Bruxelles

Serratus Anterior Plane Block: Post-operative Analgesia Technique in Video-assisted Thoracic Surgery. Efficacy Pilot Study and Population Pharmacokinetic Analysis

The objective of the study is to compare the efficacy of the Serratus Anterior Plane block (SPB) realised in its deep plane, with a multi-holed catheter in place for twenty four hours, to a standard intravenous analgesia for small videoassisted thoracic surgery interventions. The objective is also to evaluate the resorption rate of local anesthetic at this level, and make a population pharmacokinetic analysis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study, 20 patients will be randomly assigned to one of two groups: ten patients will have a Serratus anterior plane block (SPB), with a first ropivacaine 0,375% bolus (0,4ml/kg), followed by an infusion of ropivacaine 0,2% at a 10ml/hr rate, through a multi-holed catheter located under the serratus anterior muscle, for a duration of 24 hours. The other group will have a standard intravenous analgesia with a PCA morphine-dehydrobenzperidol pump. Anesthesia protocol will be standardized. Except the infusion of ropivacaine for the SPB, per operative anesthesia and post operative analgesia will be the same for every usual patients.

The investigators will evaluate post operative pain based on the visual analog scale, 24 hours morphine consumption, sensitivity of concerned territory. The investigators will also evaluate post operative chronic pain by assessing pain two months post operatively, completing two questionnaires of neuropathic pain: DN4 and QDSA short form.

Finally, ropivacaine blood concentrations will be dosed by multiple blood samples taken over 24 hours after realizing the SPB, in order to make a population pharmacokinetic analysis, and evaluate the degree of ropivacaine resorption at this level.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Bruxelles
      • Anderlecht, Bruxelles, Belgium, 1070
        • Recruiting
        • Hôpital Erasme
        • Contact:
          • Phone Number: +3225553111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

American Society of Anesthesiologists physic status 1, 2 and 3 who require surgical video-assisted thoracoscopy or video assisted thoracic surgery without mini-thoracotomy

  1. Lung pathologies:

    • biopsies
    • symphysis, pleurectomy
    • emphysema bullae resection

  2. pleural pathologies:

    • biopsies
    • collections, intra pleural effusion

  3. mediastinal pathologies:

    • adenopathy staging
    • cysts
    • sympathectomy T2-T5
    • vagotomy
    • splanchnicectomy

Exclusion Criteria:

  1. refusal
  2. allergy to local anesthetic - contra-indication to the use of ropivacaine
  3. pregnancy
  4. liver failure
  5. severe kidney disease (GFR < 15ml/min)
  6. chronic intake of opioids
  7. neurological or psychiatric disorders interfering with pain assessment
  8. severe and morbid obesity (BMI > 35)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Serratus anterior plane block
Deep serratus anterior plane block
Procedure: Serratus anterior plane block
SPB realized under ultrasound guidance. Infiltration of local anesthetic (bolus then infusion through a multi-holed catheter) is realized under the serratus anterior muscle at a level situated around the 5th to 6th intercostal space on the anterior axillary lign, in order to anesthetize the cutaneous lateral branches of the intercostal nerves, with a first ropivacaine 0,375% bolus (0,4ml/kg), followed by an infusion of ropivacaine 0,2% at a 10ml/hr rate, through a multi-holed catheter, for a duration of 24 hours.
Other Names:
  • Deep serratus anterior plane block
  • SPB
Device: patient-controlled analgesia
Each patient controls his analgesia with an IV bolus of 2mg of morphine every 10 minutes if needed, with a maximum of 20mg every 4 hours.
Other Names:
  • PCA morphine dehydrobenzperidol
Active Comparator: patient-controlled analgesia
patient-controlled analgesia: pump containing morphine (1mg/ml) and dehydrobenzperidol (50 mcg/ml).
Device: patient-controlled analgesia
Each patient controls his analgesia with an IV bolus of 2mg of morphine every 10 minutes if needed, with a maximum of 20mg every 4 hours.
Other Names:
  • PCA morphine dehydrobenzperidol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption (mg)
Time Frame: 24 hours
Consumption of intravenous morphine
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 24 hours
Visual Analog Score: assess pain on surgical site
24 hours
Post operative nausea
Time Frame: 24 hours
Presence or absence of nausea
24 hours
Post operative vomiting
Time Frame: 24hrs
Presence or absence of vomiting
24hrs
Sensitivity of SPB zone
Time Frame: 24 hours
Cold (ether) applied on the skin of the operated hemithorax
24 hours
Post operative chronic pain
Time Frame: 2 months
Two months after surgery: QDSA-sf (short form of Questionnaire de douleur de Saint-Antoine)
2 months
Post operative chronic pain
Time Frame: 2 months
Two months after surgery: DN4 questionnaire
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Libre de Bruxelles

Investigators

  • Principal Investigator: Luc Van Obbergh, Anesthesiology chief

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2017

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

August 25, 2017

First Submitted That Met QC Criteria

September 6, 2017

First Posted (Actual)

September 11, 2017

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 6, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2017/170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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