Pain, Postoperative Clinical Trial
Official title:
Blocco Del Dentato Anteriore e Blocco Del Muscolo Erettore Della Colonna Vertebrale Nella Gestione Multimodale Del Dolore in Chirurgia Toracica Mininvasiva: Studio Osservazionale Prospettico Multicentrico
Thoracic surgery is characterized by acute perioperative pain. There are different ways to provide analgesia, such as intravenous analgesics (opioids or non-opioids) or loco-regional procedures; these techniques are often used together in the context of a multimodal approach to pain management, in order to exploit their synergistic action and minimize side effects. In this observational prospective multicentric study the investigators evaluate the effectiveness of two routinely administered ultrasound guided loco-regional analgesic techniques in providing analgesia to patients undergoing mini-invasive lung-resective thoracic surgery. The two techniques compared are the serratus anterior plane (SAP) block and the erector spinae plane (ESP) block.
Status | Recruiting |
Enrollment | 170 |
Est. completion date | July 31, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Lung-resective thoracic surgery (lobectomy, bilobectomy, segmentectomy and wedge resection) with videothoracoscopic or mini-thoracotomic approach (maximum duration 180 minutes) - BMI ranging from 18 to 30 - Age > 18 years - ASA I-III - Ultrasound guided preoperative ESP block or SAP block - Remifentanil as intraoperative opioid Exclusion Criteria: - Patient's refusal - Weight < 50 kg - Pregnancy - Emergent surgery - Chronic opioid therapy - History of drug or benzodiazepine addiction or alcohol abuse - Previous thoracic surgery |
Country | Name | City | State |
---|---|---|---|
Italy | Cliniche Humanitas Gavazzeni | Bergamo | |
Italy | A.O.U. Città della Salute e della Scienza - Molinette Hospital | Torino | |
Italy | Cattinara Hospital | Trieste |
Lead Sponsor | Collaborator |
---|---|
University of Trieste | A.O.U. Città della Salute e della Scienza - Molinette Hospital, Cliniche Humanitas Gavazzeni |
Italy,
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
Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11. — View Citation
Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581. — View Citation
Doan LV, Augustus J, Androphy R, Schechter D, Gharibo C. Mitigating the impact of acute and chronic post-thoracotomy pain. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):1048-56. doi: 10.1053/j.jvca.2014.02.021. Review. — View Citation
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 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. — View Citation
Khalil AE, Abdallah NM, Bashandy GM, Kaddah TA. Ultrasound-Guided Serratus Anterior Plane Block Versus Thoracic Epidural Analgesia for Thoracotomy Pain. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):152-158. doi: 10.1053/j.jvca.2016.08.023. Epub 2016 Aug 21. — View Citation
Leyva FM, Mendiola WE, Bonilla AJ, Cubillos J, Moreno DA, Chin KJ. Continuous Erector Spinae Plane (ESP) Block for Postoperative Analgesia after Minimally Invasive Mitral Valve Surgery. J Cardiothorac Vasc Anesth. 2018 Oct;32(5):2271-2274. doi: 10.1053/j.jvca.2017.12.020. Epub 2017 Dec 12. — View Citation
Luis-Navarro JC, Seda-Guzmán M, Luis-Moreno C, López-Romero JL. The erector spinae plane block in 4 cases of video-assisted thoracic surgery. Rev Esp Anestesiol Reanim. 2018 Apr;65(4):204-208. doi: 10.1016/j.redar.2017.12.004. Epub 2018 Jan 11. English, Spanish. — View Citation
McGovern I, Walker C, Cox F. Pain relief after thoracotomy. Br J Anaesth. 2007 Jun;98(6):844; author reply 844-5. — View Citation
Ökmen K, Ökmen BM. The efficacy of serratus anterior plane block in analgesia for thoracotomy: a retrospective study. J Anesth. 2017 Aug;31(4):579-585. doi: 10.1007/s00540-017-2364-9. Epub 2017 Apr 26. — View Citation
Rao Kadam V, Currie J. Ultrasound-guided continuous erector spinae plane block for postoperative analgesia in video-assisted thoracotomy. Anaesth Intensive Care. 2018 Mar;46(2):243-245. — View Citation
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 Jul/Aug;42(4):537. doi: 10.1097/AAP.0000000000000616. — View Citation
Wenk M, Schug SA. Perioperative pain management after thoracotomy. Curr Opin Anaesthesiol. 2011 Feb;24(1):8-12. doi: 10.1097/ACO.0b013e3283414175. Review. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morphine consumption | Evaluation of morphine consumption in the first 24 hours after surgery | First 24 hours after surgery | |
Secondary | Intraoperative opioid consumption | Evaluation of opioid consumption during lung-resective thoracic surgery | Duration of surgical procedure | |
Secondary | Numeric Rating Scale (NRS) | Evaluation of NRS for static, dynamic and cough-associated pain | First 24 hours after surgery, then after 3 months | |
Secondary | Analgesic rescue and corticosteroids | Evaluation of eventual administration of rescue analgesic drugs and corticosteroids in the first 24 hours after surgery | First 24 hours after surgery | |
Secondary | Side effects | Evaluation of eventual side effects related to the locoregional techinque or the analgesics used (LAST, hypotension, Post Operative Nausea and Vomiting (PONV) and opioid-related side effects) in the first 24 hours after surgery | First 24 hours after surgery |
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