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

NCT ID: NCT03277391

Last Updated: 2017-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-14

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Random attribution by computer

Study Groups

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Serratus anterior plane block

Deep serratus anterior plane block

Group Type ACTIVE_COMPARATOR

Serratus anterior plane block

Intervention Type PROCEDURE

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.

patient-controlled analgesia

Intervention Type DEVICE

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.

patient-controlled analgesia

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

Group Type ACTIVE_COMPARATOR

patient-controlled analgesia

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Other Intervention Names

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Deep serratus anterior plane block SPB PCA morphine dehydrobenzperidol

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université Libre de Bruxelles

OTHER

Sponsor Role lead

Responsible Party

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Paul Gruson

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luc Van Obbergh

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology chief

Locations

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Hopital Erasme

Anderlecht, Brussels Capital, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Paul Gruson

Role: CONTACT

0032 2 555 5850

Facility Contacts

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Role: primary

+3225553111

References

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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.

Reference Type BACKGROUND
PMID: 15232812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23923989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27228541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26000690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26449303 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20298428 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25640290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7978472 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2679230 (View on PubMed)

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.

Reference Type RESULT
PMID: 18713924 (View on PubMed)

Other Identifiers

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P2017/170

Identifier Type: -

Identifier Source: org_study_id

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