Erector Spinae Plane (ESP) Block versus Thoracic Epidural Analgesia (TEA) in Video-Assisted Thoracic Surgery (VATS): A Prospective Randomized Open Label Non-Inferiority Trial

Not Applicable

Conditions: lungcancer, postoperative pain
10038737

Registration Number: NL-OMON22453

Lead Sponsor: Catharina ziekenhuis Eindhoven

Brief Summary: (1) Gupta A, Kaur K, Sharma S, Goyal S, Arora S, Murthy RS. Clinical aspects of acute post-operative pain management & its assessment. J Adv Pharm Technol Res. 2010;1(2):97–108. (2)Rosero EB, Joshi GP. Preemptive, preventive, multimodal analgesia: what do they really mean? Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):85S–93S. (3)Analgesia in thoracic surgery: review. - PubMed - NCBI [Internet]. [cited 2018 Feb 12]. Available from: https://www.ncbi.nlm.nih.gov/pubmed/18953284 (4)Mungroop TH, Veelo DP, Busch OR, van Dieren S, van Gulik TM, Karsten TM, et al. Continuous wound infiltration versus epidural analgesia after hepato-pancreato-biliary surgery (POP-UP): a randomised controlled, open-label, non-inferiority trial. Lancet Gastroenterol Hepatol. 1(2):105–13. (5)Gottschalk A, Cohen SP, Yang S, Ochroch EA. Preventing and Treating Pain after Thoracic Surgery. Anesthesiol J Am Soc Anesthesiol. 2006 Mar 1;104(3):594–600. (6)Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016;41(5):621–7. (7)Scimia P, Basso Ricci E, Droghetti A, Fusco P. The Ultrasound-Guided Continuous Erector Spinae Plane Block for Postoperative Analgesia in Video-Assisted Thoracoscopic Lobectomy. Reg Anesth Pain Med. 2017 Aug;42(4):537. (8)Adhikary SD, Pruett A, Forero M, Thiruvenkatarajan V. Erector spinae plane block as an alternative to epidural analgesia for post-operative analgesia following video-assisted thoracoscopic surgery: A case study and a literature review on the spread of local anaesthetic in the erector spinae plane. Indian J Anaesth. 2018 Jan 1;62(1):75. (9) Lehmann N, Joshi GP, Dirkmann D, Weiss M, Gulur P, Peters J, et al. Development and longitudinal validation of the overall benefit of analgesia score: a simple multi-dimensional quality assessment instrument. Br J Anaesth. 2010 Oct;105(4):511–8.

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria: (1) Age between 18 and 75 years old, (2) BMI between 20 and 30kg/m 2 , (3) scheduled for elective VATS, and (4) written informed consent.

Exclusion Criteria

Exclusion criteria are as follows: (1) ASA status = 4, (2) chronic opioid use (> 3 months of strong opioids, weak opioids such as tramadol are allowed), (3) renal or liver failure inhibiting the systematic use of paracetamol and/or NSAIDs, (4) contraindication for epidural analgesia (e.g. INR or platelets according to local protocol, local infection at the surgery site or puncture site) (5) allergy to study medication, (6) pregnancy, (7) cognitive impairment, (8) insufficient comprehension of the Dutch QoR-40 questionnaire.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of this study is the QoR15 (See section 6.1.) on POD1 and 2 including subscale analysis Comfort; Emotions, Independence, Support and Pain).</p><br>

Secondary Outcome Measures