Serratus Anterior Plane Block: Post-operative Analgesia in Video-assisted Thoracic Surgery (Serrathos)
Primary Purpose
Regional Anesthesia, Thoracic Surgery, Post-operative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Serratus anterior plane block
patient-controlled analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Regional Anesthesia
Eligibility Criteria
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
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
Exclusion Criteria:
- 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)
Sites / Locations
- Hopital ErasmeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Serratus anterior plane block
patient-controlled analgesia
Arm Description
Deep serratus anterior plane block
patient-controlled analgesia: pump containing morphine (1mg/ml) and dehydrobenzperidol (50 mcg/ml).
Outcomes
Primary Outcome Measures
Morphine consumption (mg)
Consumption of intravenous morphine
Secondary Outcome Measures
Pain score
Visual Analog Score: assess pain on surgical site
Post operative nausea
Presence or absence of nausea
Post operative vomiting
Presence or absence of vomiting
Sensitivity of SPB zone
Cold (ether) applied on the skin of the operated hemithorax
Post operative chronic pain
Two months after surgery: QDSA-sf (short form of Questionnaire de douleur de Saint-Antoine)
Post operative chronic pain
Two months after surgery: DN4 questionnaire
Full Information
NCT ID
NCT03277391
First Posted
August 25, 2017
Last Updated
September 6, 2017
Sponsor
Université Libre de Bruxelles
1. Study Identification
Unique Protocol Identification Number
NCT03277391
Brief Title
Serratus Anterior Plane Block: Post-operative Analgesia in Video-assisted Thoracic Surgery
Acronym
Serrathos
Official Title
Serratus Anterior Plane Block: Post-operative Analgesia Technique in Video-assisted Thoracic Surgery. Efficacy Pilot Study and Population Pharmacokinetic Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 14, 2017 (Actual)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Libre de Bruxelles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Anesthesia, Thoracic Surgery, Post-operative Pain, Post-operative Chronic Pain, Pharmacokinetic Analysis, Serratus Anterior Plane Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Random attribution by computer
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Serratus anterior plane block
Arm Type
Active Comparator
Arm Description
Deep serratus anterior plane block
Arm Title
patient-controlled analgesia
Arm Type
Active Comparator
Arm Description
patient-controlled analgesia: pump containing morphine (1mg/ml) and dehydrobenzperidol (50 mcg/ml).
Intervention Type
Procedure
Intervention Name(s)
Serratus anterior plane block
Other Intervention Name(s)
Deep serratus anterior plane block, SPB
Intervention Description
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
Device
Intervention Name(s)
patient-controlled analgesia
Other Intervention Name(s)
PCA morphine dehydrobenzperidol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morphine consumption (mg)
Description
Consumption of intravenous morphine
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain score
Description
Visual Analog Score: assess pain on surgical site
Time Frame
24 hours
Title
Post operative nausea
Description
Presence or absence of nausea
Time Frame
24 hours
Title
Post operative vomiting
Description
Presence or absence of vomiting
Time Frame
24hrs
Title
Sensitivity of SPB zone
Description
Cold (ether) applied on the skin of the operated hemithorax
Time Frame
24 hours
Title
Post operative chronic pain
Description
Two months after surgery: QDSA-sf (short form of Questionnaire de douleur de Saint-Antoine)
Time Frame
2 months
Title
Post operative chronic pain
Description
Two months after surgery: DN4 questionnaire
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Gruson
Phone
0032 2 555 5850
Email
paulgruson.dr@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Van Obbergh
Organizational Affiliation
Anesthesiology chief
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Erasme
City
Anderlecht
State/Province
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Phone
+3225553111
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15232812
Citation
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.
Results Reference
background
PubMed Identifier
23923989
Citation
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.
Results Reference
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PubMed Identifier
27228541
Citation
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.
Results Reference
background
PubMed Identifier
26000690
Citation
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.
Results Reference
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PubMed Identifier
26449303
Citation
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.
Results Reference
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PubMed Identifier
20298428
Citation
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.
Results Reference
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PubMed Identifier
25640290
Citation
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.
Results Reference
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PubMed Identifier
7978472
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Serratus Anterior Plane Block: Post-operative Analgesia in Video-assisted Thoracic Surgery
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