SAP Versus ESP Block in Multimodal Pain Management in Mini-invasive Thoracic Surgery: an Observational Prospective Multicentric Study

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04303585
• Other study ID #: 145_2018 Blocco gran dentato
• Status: Recruiting
• Start date: June 27, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: July 2020
• Source: University of Trieste
• Contact: Marzia Umari, MD
• Phone: 347 4688773
• Email: marzia.umari[@]asuits.sanita.fvg.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Whatever the loco-regional technique is (SAP block or ESP block), it must have been administered in the immediate preoperative phase; both procedures are routinely used for analgesic purpose in the clinical practice of the three centers involved in the study and are performed under ultrasound guide. Using medical records, data collected by Acute Pain Service nurses and patients' interviews useful data will be collected: demographic and clinical characteristics (age, sex, weight, comorbidities), surgical data (type of procedure, surgical approach and duration of surgery) and anesthesia data (type of block, dose and type of local anesthetic with record of potential side effects), intraoperative and postoperative opioid and non-opioid analgesic consumption (and rescue if needed) with record of potential side effects, pain evaluation in the first 24 hours after surgery and after at 3 months.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Evaluation of Locoregional Techniques
• Multimodal Pain Management
• Pain, Postoperative
• SAP Block Versus ESP Block

Intervention

Procedure:
• SAP block
The anesthesiologist performs SAP block immediately before surgery under ultrasound guide
• ESP block
The anesthesiologist performs ESP block immediately before surgery under ultrasound guide

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Trieste	A.O.U. Città della Salute e della Scienza - Molinette Hospital, Cliniche Humanitas Gavazzeni

Country where clinical trial is conducted

Italy, 

References & Publications (13)

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

Outcome

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