Thoracic Surgery Clinical Trial
— SerrathosOfficial 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.
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) |
Country | Name | City | State |
---|---|---|---|
Belgium | Hopital Erasme | Anderlecht | Bruxelles |
Lead Sponsor | Collaborator |
---|---|
Université Libre de Bruxelles |
Belgium,
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
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 |
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