Efficacy of Continous Regional Anesthesia Using m. Erector Spinae Catheter After VATS Procedures

Thoracic Surgery, Video-Assisted Clinical Trial

Official title:

Efficacy of Continous Regional Anesthesia Using m. Erector Spinae Catheter After Video-assisted Thoracic Surgery Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04062045
• Other study ID #: 0120- 372/2019
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: May 2022

Study information

• Verified date: November 2020
• Source: Surgery Bitenc
• Contact: Polona Gams, MD
• Phone: 00386 41 522 968
• Email: polona.gams[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators will analyze the efficacy of continuous regional anesthesia through a catheter under erector spinae muscle in a prospective, randomized, double blind, placebo-controlled study. Investigators will include 50 adults, predicted for elective lung surgery with video-assisted thoracic surgery (VATS) technique. Patients will be randomly assigned to group A or B. Investigators will insert a catheter under the erector spinae muscle (ESC) at the T4 level of the operated side under ultrasound guidance. All patients will receive an initial bolus of 20ml levobupivacaine 0,5% through the catheter. Group A will receive a continuous infusion 5ml/h of ropivacaine 0,2% and intermittent boluses of the same local anesthetic 15ml/4h through the ESC. Group B will receive a continuous infusion of 0,9% saline in the same doses. All patients will have a PCA pump with piritramide 1mg/ml to cover the pain. All patients will receive regular doses of paracetamol and metamizole as part of multimodal analgesia. Investigators will compare pain, assessed with the VAS scale in resting and coughing and piritramide usage in both groups. Investigators will compare the incentive spirometry results at 24 and 48 hours postoperatively and observe for possible late complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed written informed consent
• ASA I-III
• Elective video-assisted thoracic surgery with 3 ports technique
• No contraindications for regional anesthesia

Exclusion Criteria:

• Allergy to local anesthetic
• Pregnancy, breastfeeding
• BMI>35
• Inflammation in the area of ES catheter insertion
• Inability to use the PCA pump

Related Conditions & MeSH terms

• Lung Neoplasms
• Neoplasm of Lung
• Thoracic Surgery, Video-Assisted

Intervention

Drug:
• Ropivacaine Hcl 0.2% Inj Vil 10Ml
Group A will receive the medicine through the erector spinae catheter.
• Saline 0.9%
Group B will receive Saline 0,9% through the erector spinae catheter.

Locations

Country	Name	City	State
Slovenia	Surgery Bitenc	Golnik

Sponsors (1)

Lead Sponsor	Collaborator
Surgery Bitenc

Country where clinical trial is conducted

Slovenia, 

References & Publications (17)

Ahmed Z, Samad K, Ullah H. Role of intercostal nerve block in reducing postoperative pain following video-assisted thoracoscopy: A randomized controlled trial. Saudi J Anaesth. 2017 Jan-Mar;11(1):54-57. doi: 10.4103/1658-354X.197342. — View Citation

Bialka S, Copik M, Daszkiewicz A, Rivas E, Ruetzler K, Szarpak L, Misiolek H. Comparison of different methods of postoperative analgesia after thoracotomy-a randomized controlled trial. J Thorac Dis. 2018 Aug;10(8):4874-4882. doi: 10.21037/jtd.2018.07.88. — View Citation

de Haan JB, Hernandez N, Sen S. Erector spinae block for postoperative analgesia following axillary hidradenitis suppurativa resection: a case report. Local Reg Anesth. 2018 Nov 15;11:87-90. doi: 10.2147/LRA.S179830. eCollection 2018. — 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

Gürkan Y, Aksu C, Kus A, Yörükoglu UH, Kiliç CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2. — View Citation

Helms O, Mariano J, Hentz JG, Santelmo N, Falcoz PE, Massard G, Steib A. Intra-operative paravertebral block for postoperative analgesia in thoracotomy patients: a randomized, double-blind, placebo-controlled study. Eur J Cardiothorac Surg. 2011 Oct;40(4):902-6. doi: 10.1016/j.ejcts.2011.01.067. Epub 2011 Mar 5. Review. — View Citation

Hong B, Bang S, Chung W, Yoo S, Chung J, Kim S. Multimodal analgesia with multiple intermittent doses of erector spinae plane block through a catheter after total mastectomy: a retrospective observational study. Korean J Pain. 2019 Jul 1;32(3):206-214. doi: 10.3344/kjp.2019.32.3.206. — View Citation

Ince I, Ozmen O, Aksoy M, Zeren S, Ulas AB, Aydin Y. Erector Spinae Plane Block Catheter Insertion under Ultrasound Guidance for Thoracic Surgery: Case Series of Three Patients. Eurasian J Med. 2018 Oct;50(3):204-206. doi: 10.5152/eurasianjmed.2018.18147. — View Citation

Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andrés J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19. Review. — View Citation

Kwon WJ, Bang SU, Sun WY. Erector Spinae Plane Block for Effective Analgesia after Total Mastectomy with Sentinel or Axillary Lymph Node Dissection: a Report of Three Cases. J Korean Med Sci. 2018 Nov 5;33(45):e291. doi: 10.3346/jkms.2018.33.e291. — 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

Piccioni F, Ragazzi R. Anesthesia and analgesia: how does the role of anesthetists changes in the ERAS program for VATS lobectomy. J Vis Surg. 2018 Jan 11;4:9. doi: 10.21037/jovs.2017.12.11. eCollection 2018. — 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

Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603. — View Citation

Tulgar S, Senturk O. Ultrasound guided Erector Spinae Plane block at L-4 transverse process level provides effective postoperative analgesia for total hip arthroplasty. J Clin Anesth. 2018 Feb;44:68. doi: 10.1016/j.jclinane.2017.11.006. Epub 2017 Nov 14. — View Citation

Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8. — View Citation

Yenidünya O, Bircan HY, Altun D, Caymaz I, Demirag A, Turkoz A. Anesthesia management with ultrasound-guided thoracic paravertebral block for donor nephrectomy: A prospective randomized study. J Clin Anesth. 2017 Feb;37:1-6. doi: 10.1016/j.jclinane.2016.10.038. Epub 2016 Dec 15. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	Investigators will follow up the patients in weeks after surgery for possible complications.	2 months
Primary	Usage of opioid analgetics	Investigators will measure the total consumption of i.v. piritramide after surgery.	Continually 48 hours post surgery
Secondary	Subjective pain score	Investigators will measure subjective perception of pain with the visual analogue scale (VAS) scoring system at resting and coughing. The VAS scoring system is a numerical scale from 0-10, with 0 being no pain and 10 the strongest pain imaginable. Patients will assess their pain with the help of analogue scale with colours and faces by each number representing different VAS pain levels.	Every hour in the 48 hours post surgery
Secondary	Incentive spirometry	Investigators will assess spirometry with a manual device.	24 and 48 hours after surgery
Secondary	Satisfaction with analgesia	Investigators will assess satisfaction with qualitative and quantitative questionnaries.	1 day (at dismissal from hospital.)