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

Thoracic Surgery Clinical Trial

— Serrathos  

Official title:

Serratus Anterior Plane Block: Post-operative Analgesia Technique in Video-assisted Thoracic Surgery. Efficacy Pilot Study and Population Pharmacokinetic Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03277391
• Other study ID #: P2017/170
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2017
• Last updated: September 6, 2017
• Start date: April 14, 2017
• Est. completion date: May 2018

Study information

• Verified date: September 2017
• Source: Université Libre de Bruxelles
• Contact: Paul Gruson
• Phone: 0032 2 555 5850
• Email: paulgruson.dr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The objective is also to evaluate the resorption rate of local anesthetic at this level, and make a population pharmacokinetic analysis.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
Belgium	Hopital Erasme	Anderlecht	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

References & Publications (10)

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. — View Citation

Broseta AM, Errando C, De Andrés J, Díaz-Cambronero O, Ortega-Monzó J. Serratus plane block: the regional analgesia technique for thoracoscopy? Anaesthesia. 2015 Nov;70(11):1329-30. doi: 10.1111/anae.13263. — View 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. Review. — View 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. — View 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. — View 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- — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption (mg)	Consumption of intravenous morphine	24 hours
Secondary	Pain score	Visual Analog Score: assess pain on surgical site	24 hours
Secondary	Post operative nausea	Presence or absence of nausea	24 hours
Secondary	Post operative vomiting	Presence or absence of vomiting	24hrs
Secondary	Sensitivity of SPB zone	Cold (ether) applied on the skin of the operated hemithorax	24 hours
Secondary	Post operative chronic pain	Two months after surgery: QDSA-sf (short form of Questionnaire de douleur de Saint-Antoine)	2 months
Secondary	Post operative chronic pain	Two months after surgery: DN4 questionnaire	2 months