NCT03277391

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

12 months

First QC Date

August 25, 2017

Last Update Submit

September 6, 2017

Conditions

Regional AnesthesiaThoracic SurgeryPost-operative PainPost-operative Chronic PainPharmacokinetic AnalysisSerratus Anterior Plane Block

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption (mg)

    Consumption of intravenous morphine

    24 hours

Secondary Outcomes (6)

  • Pain score

    24 hours

  • Post operative nausea

    24 hours

  • Post operative vomiting

    24hrs

  • Sensitivity of SPB zone

    24 hours

  • Post operative chronic pain

    2 months

  • +1 more secondary outcomes

Study Arms (2)

Serratus anterior plane block

ACTIVE COMPARATOR

Deep serratus anterior plane block

Procedure: Serratus anterior plane blockDevice: patient-controlled analgesia

patient-controlled analgesia

ACTIVE COMPARATOR

patient-controlled analgesia: pump containing morphine (1mg/ml) and dehydrobenzperidol (50 mcg/ml).

Device: patient-controlled analgesia

Interventions

Serratus anterior plane blockPROCEDURE

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.

Also known as: Deep serratus anterior plane block, SPB
Serratus anterior plane block
patient-controlled analgesiaDEVICE

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.

Also known as: PCA morphine dehydrobenzperidol
Serratus anterior plane blockpatient-controlled analgesia

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists physic status 1, 2 and 3 who require surgical video-assisted thoracoscopy or video assisted thoracic surgery without mini-thoracotomy
  • Lung pathologies:
  • biopsies
  • symphysis, pleurectomy
  • emphysema bullae resection
  • pleural pathologies:
  • biopsies
  • collections, intra pleural effusion
  • mediastinal pathologies:
  • adenopathy staging
  • cysts
  • sympathectomy T2-T5
  • vagotomy
  • splanchnicectomy

You may not qualify if:

  • refusal
  • allergy to local anesthetic - contra-indication to the use of ropivacaine
  • pregnancy
  • liver failure
  • severe kidney disease (GFR \< 15ml/min)
  • chronic intake of opioids
  • neurological or psychiatric disorders interfering with pain assessment
  • severe and morbid obesity (BMI \> 35)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Erasme

Anderlecht, Brussels Capital, 1070, Belgium

RECRUITING

Related Publications (10)

  • Taylor R, Massey S, Stuart-Smith K. Postoperative analgesia in video-assisted thoracoscopy: the role of intercostal blockade. J Cardiothorac Vasc Anesth. 2004 Jun;18(3):317-21. doi: 10.1053/j.jvca.2004.03.012.

    PMID: 15232812BACKGROUND

  • Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

    PMID: 23923989BACKGROUND

  • Font MC, Navarro-Martinez J, Nadal SB, Munoz CG, Galiana-Ivars M, Montero PC. Continuous Analgesia Using a Multi-Holed Catheter in Serratus Plane for Thoracic Surgery. Pain Physician. 2016 May;19(4):E684-5. No abstract available.

    PMID: 27228541BACKGROUND

  • Madabushi R, Tewari S, Gautam SK, Agarwal A, Agarwal A. Serratus anterior plane block: a new analgesic technique for post-thoracotomy pain. Pain Physician. 2015 May-Jun;18(3):E421-4.

    PMID: 26000690BACKGROUND

  • Broseta AM, Errando C, De Andres J, Diaz-Cambronero O, Ortega-Monzo J. Serratus plane block: the regional analgesia technique for thoracoscopy? Anaesthesia. 2015 Nov;70(11):1329-30. doi: 10.1111/anae.13263. No abstract available.

    PMID: 26449303BACKGROUND

  • Cruccu G, Sommer C, Anand P, Attal N, Baron R, Garcia-Larrea L, Haanpaa M, Jensen TS, Serra J, Treede RD. EFNS guidelines on neuropathic pain assessment: revised 2009. Eur J Neurol. 2010 Aug;17(8):1010-8. doi: 10.1111/j.1468-1331.2010.02969.x. Epub 2010 Mar 8.

    PMID: 20298428BACKGROUND

  • Dworkin RH, Turk DC, Trudeau JJ, Benson C, Biondi DM, Katz NP, Kim M. Validation of the Short-form McGill Pain Questionnaire-2 (SF-MPQ-2) in acute low back pain. J Pain. 2015 Apr;16(4):357-66. doi: 10.1016/j.jpain.2015.01.012. Epub 2015 Jan 29.

    PMID: 25640290BACKGROUND

  • Kopacz DJ, Emanuelsson BM, Thompson GE, Carpenter RL, Stephenson CA. Pharmacokinetics of ropivacaine and bupivacaine for bilateral intercostal blockade in healthy male volunteers. Anesthesiology. 1994 Nov;81(5):1139-48. doi: 10.1097/00000542-199411000-00007.

    PMID: 7978472BACKGROUND

  • Scott DB, Lee A, Fagan D, Bowler GM, Bloomfield P, Lundh R. Acute toxicity of ropivacaine compared with that of bupivacaine. Anesth Analg. 1989 Nov;69(5):563-9.

    PMID: 2679230BACKGROUND

  • Joshi GP, Bonnet F, Shah R, Wilkinson RC, Camu F, Fischer B, Neugebauer EA, Rawal N, Schug SA, Simanski C, Kehlet H. A systematic review of randomized trials evaluating regional techniques for postthoracotomy analgesia. Anesth Analg. 2008 Sep;107(3):1026-40. doi: 10.1213/01.ane.0000333274.63501.ff.

    PMID: 18713924RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Officials

  • Luc Van Obbergh

    Anesthesiology chief

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Gruson

CONTACT

0032 2 555 5850paulgruson.dr@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Random attribution by computer
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 25, 2017

First Posted

September 11, 2017

Study Start

April 14, 2017

Primary Completion

April 1, 2018

Study Completion

May 1, 2018

Last Updated

September 11, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)