Clincosm LogoSign in Get a demo

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

Sponsor
Université Libre de Bruxelles (Other)
Overall Status
Unknown status
CT.gov ID
NCT03277391
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
12.6
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Serratus anterior plane block
  • Device: patient-controlled analgesia
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Random attribution by computer
Primary Purpose:
Treatment
Official Title:
Serratus Anterior Plane Block: Post-operative Analgesia Technique in Video-assisted Thoracic Surgery. Efficacy Pilot Study and Population Pharmacokinetic Analysis
Actual Study Start Date :
Apr 14, 2017
Anticipated Primary Completion Date :
Apr 1, 2018
Anticipated Study Completion Date :
May 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Morphine consumption (mg) [24 hours]

      Consumption of intravenous morphine

    Secondary Outcome Measures

    1. Pain score [24 hours]

      Visual Analog Score: assess pain on surgical site

    2. Post operative nausea [24 hours]

      Presence or absence of nausea

    3. Post operative vomiting [24hrs]

      Presence or absence of vomiting

    4. Sensitivity of SPB zone [24 hours]

      Cold (ether) applied on the skin of the operated hemithorax

    5. Post operative chronic pain [2 months]

      Two months after surgery: QDSA-sf (short form of Questionnaire de douleur de Saint-Antoine)

    6. Post operative chronic pain [2 months]

      Two months after surgery: DN4 questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. pleural pathologies:

    • biopsies

    • collections, intra pleural effusion

    1. 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hopital Erasme Anderlecht Bruxelles Belgium 1070

    Sponsors and Collaborators

    • Université Libre de Bruxelles

    Investigators

    • Principal Investigator: Luc Van Obbergh, Anesthesiology chief

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Paul Gruson, Principal investigator, Université Libre de Bruxelles
    ClinicalTrials.gov Identifier:
    NCT03277391
    Other Study ID Numbers:
    • P2017/170
    First Posted:
    Sep 11, 2017
    Last Update Posted:
    Sep 11, 2017
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Chronic Pain
    Pain, Postoperative
    Droperidol
    Morphine

    Study Results

    No Results Posted as of Sep 11, 2017