Regional AnesthesiaSerrathosNCT03277391
Serratus Anterior Plane Block: Post-operative Analgesia in Video-assisted Thoracic Surgery
A study testing Serratus anterior plane block in people with Regional Anesthesia and Thoracic Surgery, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Regional Anesthesia, Thoracic Surgery, Post-operative Pain
- What is being tested?
- Serratus anterior plane block
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Apr 2017to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- biopsies
- collections, intra pleural effusion
- mediastinal pathologies:
- adenopathy staging
- cysts
- sympathectomy T2-T5
- vagotomy
- splanchnicectomy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hopital Erasme
Anderlecht, Brussels Capital, 1070
+3225553111
About this study
Official title: Serratus Anterior Plane Block: Post-operative Analgesia Technique in Video-assisted Thoracic Surgery. Efficacy Pilot Study and Population Pharmacokinetic Analysis
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.
- Conditions
- Regional Anesthesia, Thoracic Surgery, Post-operative Pain, Post-operative Chronic Pain, Pharmacokinetic Analysis, Serratus Anterior Plane Block
- Being tested
- Serratus anterior plane block, patient-controlled analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus anterior plane blockProcedure or surgery
Also called Deep serratus anterior plane block, SPB
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 analgesiaDevice
Also called PCA morphine dehydrobenzperidol
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.
| Study group | Role | What they receive |
|---|---|---|
| Serratus anterior plane block | Active comparator | Deep serratus anterior plane block Receives: Procedure: Serratus anterior plane block; Device: patient-controlled analgesia |
| patient-controlled analgesia | Active comparator | patient-controlled analgesia: pump containing morphine (1mg/ml) and dehydrobenzperidol (50 mcg/ml). Receives: Device: patient-controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption (mg)
Consumption of intravenous morphine
Measured: 24 hours
Secondary outcomes (6)
Pain score
Visual Analog Score: assess pain on surgical site
Measured: 24 hours
Post operative nausea
Presence or absence of nausea
Measured: 24 hours
Post operative vomiting
Presence or absence of vomiting
Measured: 24hrs
Sensitivity of SPB zone
Cold (ether) applied on the skin of the operated hemithorax
Measured: 24 hours
Post operative chronic pain
Two months after surgery: QDSA-sf (short form of Questionnaire de douleur de Saint-Antoine)
Measured: 2 months
Post operative chronic pain
Two months after surgery: DN4 questionnaire
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start14 Apr 2017
- Primary completionApr 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Gruson, Université Libre de Bruxelles
- Investigators
- Luc Van Obbergh, Principal investigator, Anesthesiology chief
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277391
- Sponsor's protocol ID
- P2017/170
- Acronym
- Serrathos
- Status last verified
- Sep 2017
- First submitted
- 25 Aug 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 15232812Blanco 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 23923989Font 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 27228541Madabushi 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 26000690Broseta 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 26449303Cruccu 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 20298428Dworkin 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 25640290Kopacz 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 7978472Scott 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 2679230Joshi 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Anterior Plane Block: Post-operative Analgesia Technique in Video-assisted Thoracic Surgery. Efficacy Pilot Study and Population Pharmacokinetic Analysis
- ClinicalTrials.gov ID
- NCT03277391
- Acronym / sponsor ID
- Serrathos / P2017/170
- Conditions
- Regional Anesthesia, Thoracic Surgery, Post-operative Pain, Post-operative Chronic Pain, Pharmacokinetic Analysis, Serratus Anterior Plane Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus anterior plane block | Active comparator | Procedure: Serratus anterior plane block, Device: patient-controlled analgesiaDeep serratus anterior plane block |
| patient-controlled analgesia | Active comparator | Device: patient-controlled analgesiapatient-controlled analgesia: pump containing morphine (1mg/ml) and dehydrobenzperidol (50 mcg/ml). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- pleural pathologies:
- mediastinal pathologies:
Key exclusion criteria (8 listed)
- refusal
- allergy to local anesthetic - contra-indication to the use of ropivacaine
- pregnancy
- liver failure
- severe kidney disease (GFR < 15ml/min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serratus anterior plane blockAlso: Deep serratus anterior plane block, SPBSPB 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. | Procedure or surgery | Serratus anterior plane block |
| patient-controlled analgesiaAlso: PCA morphine dehydrobenzperidolEach 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. | Device | Serratus anterior plane block, patient-controlled analgesia |
Primary outcome
Morphine consumption (mg)
Time frame: 24 hours
Consumption of intravenous morphine
6 secondary outcomes
Pain score
Time frame: 24 hours
Post operative nausea
Time frame: 24 hours
Post operative vomiting
Time frame: 24hrs
Sensitivity of SPB zone
Time frame: 24 hours
Post operative chronic pain
Time frame: 2 months
Post operative chronic pain
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Background: PubMed 15232812Taylor 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.
- Background: PubMed 23923989Blanco 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.
- Background: PubMed 27228541Font 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.
- Background: PubMed 26000690Madabushi 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.
- Background: PubMed 26449303Broseta 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.
- Background: PubMed 20298428Cruccu 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.
- Background: PubMed 25640290Dworkin 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.
- Background: PubMed 7978472Kopacz 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.
- Background: PubMed 2679230Scott 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 publication: PubMed 18713924Joshi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Van Obbergh principal investigator
Anesthesiology chief
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus anterior plane block in people with Regional Anesthesia and Thoracic Surgery, run by Université Libre de Bruxelles at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Gruson (0032 2 555 5850, paulgruson.dr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (mg) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03277391, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.