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Status unknownNCT03277391SerrathosUpdated Sep 11, 2017

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

An interventional study of Serratus anterior plane block and patient-controlled analgesia in Regional Anesthesia, Thoracic Surgery and Post-operative Pain, sponsored by Université Libre de Bruxelles. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-09-11.

Sponsored by Université Libre de Bruxelles · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Regional Anesthesia
  • Thoracic Surgery
  • Post-operative Pain
  • Post-operative Chronic Pain
  • Pharmacokinetic Analysis
  • Serratus Anterior Plane Block
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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
  2. pleural pathologies:

    • biopsies
    • collections, intra pleural effusion
  3. mediastinal pathologies:

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

Exclusion criteria

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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Serratus anterior plane block

    Deep serratus anterior plane block

    Procedure: Serratus anterior plane block · Device: patient-controlled analgesia

  • Active comparator
    patient-controlled analgesia

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

    Device: patient-controlled analgesia

Interventions

  • ProcedureSerratus 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.

    Also known as: Deep serratus anterior plane block, SPB

  • Devicepatient-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.

    Also known as: PCA morphine dehydrobenzperidol

05

What researchers measure

Primary outcomes

  1. Morphine consumption (mg)

    Consumption of intravenous morphine

    Time frame: 24 hours

Secondary outcomes

  1. Pain score

    Visual Analog Score: assess pain on surgical site

    Time frame: 24 hours

  2. Post operative nausea

    Presence or absence of nausea

    Time frame: 24 hours

  3. Post operative vomiting

    Presence or absence of vomiting

    Time frame: 24hrs

  4. Sensitivity of SPB zone

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

    Time frame: 24 hours

  5. Post operative chronic pain

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

    Time frame: 2 months

  6. Post operative chronic pain

    Two months after surgery: DN4 questionnaire

    Time frame: 2 months

06

Study locations

1 of 1 sites recruiting
  • Hopital Erasme
    Anderlecht, Bruxelles 1070, Belgium
    • · Contact · +3225553111
    Recruiting
07

References and documents

Publications

  • 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. PubMed 15232812 ↗
  • 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. PubMed 23923989 ↗
  • 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. PubMed 27228541 ↗
  • 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. PubMed 26000690 ↗
  • 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. PubMed 26449303 ↗
  • 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. PubMed 20298428 ↗
  • 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. PubMed 25640290 ↗
  • 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. PubMed 7978472 ↗
  • 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. PubMed 2679230 ↗
  • 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. PubMed 18713924 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03277391
Lead sponsor
Université Libre de Bruxelles
Responsible party
Paul Gruson (Principal investigator, Université Libre de Bruxelles) — Principal investigator
First posted
Sep 11, 2017
Start date
Apr 14, 2017
Primary completion
Apr 2018 (estimated)
Completion
May 2018 (estimated)
Last update
Sep 11, 2017

Study contacts

Paul Gruson
Contact
paulgruson.dr@gmail.com
0032 2 555 5850
Luc Van Obbergh
principal investigator · Anesthesiology chief

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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