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

NCT04062045 | Unknown

• 1 other identifier: 0120- 372/2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasm of Lung; Thoracic Surgery, Video-Assisted

Keywords

Anesthesia, Conduction

Outcome Measures

Primary Outcomes (1)

• Usage of opioid analgetics

  Investigators will measure the total consumption of i.v. piritramide after surgery.

  Continually 48 hours post surgery

Secondary Outcomes (3)

• Subjective pain score

  Every hour in the 48 hours post surgery

• Incentive spirometry

  24 and 48 hours after surgery

• Satisfaction with analgesia

  1 day (at dismissal from hospital.)

Other Outcomes (1)

• Complications

  2 months

Study Arms (2)

Group A - Local anesthetic group

EXPERIMENTAL

Group A will receive a continuous infusion of ropivacaine 0,2% 5ml/h and intermittent boluses of the same local anesthetic 15ml/4h through the erector spinae catheter.

Drug: Ropivacaine Hcl 0.2% Inj Vil 10Ml

Group B - Placebo group

PLACEBO COMPARATOR

Group B will receive a continuous infusion of 0,9% saline 5ml/h and intermittent boluses of the same fluid 15ml/4h through the erector spinae catheter.

Drug: Saline 0.9%

Interventions

Ropivacaine Hcl 0.2% Inj Vil 10Ml DRUG

Group A will receive the medicine through the erector spinae catheter.

Group A - Local anesthetic group

Saline 0.9% DRUG

Group B will receive Saline 0,9% through the erector spinae catheter.

Group B - Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Surgery Bitenc: lead

Study Sites (1)

Surgery Bitenc

Golnik, 4204, Slovenia

RECRUITING

Related 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.

  PMID: 28217054 BACKGROUND

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  PMID: 30233861 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 30532584 BACKGROUND

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic 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.

  PMID: 29980005 BACKGROUND

• 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.

  PMID: 31033625 BACKGROUND

• 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.

  PMID: 30853517 BACKGROUND

• 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. No abstract available.

  PMID: 29149734 BACKGROUND

• 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. No abstract available.

  PMID: 28632673 BACKGROUND

• Yenidunya 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.

  PMID: 28235492 BACKGROUND

• 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.

  PMID: 21377888 BACKGROUND

• 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.

  PMID: 31257829 BACKGROUND

• 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. No abstract available.

  PMID: 31044575 BACKGROUND

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  PMID: 30886130 BACKGROUND

• 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.

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• Luis-Navarro JC, Seda-Guzman M, Luis-Moreno C, Lopez-Romero JL. The erector spinae plane block in 4 cases of video-assisted thoracic surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Apr;65(4):204-208. doi: 10.1016/j.redar.2017.12.004. Epub 2018 Jan 11. English, Spanish.

  PMID: 29336785 BACKGROUND

• 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.

  PMID: 30515044 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Polona Gams, MD

  Surgery Bitenc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Polona Gams, MD

CONTACT

00386 41 522 968; polona.gams@gmail.com

Maja Šoštarič, MD, as. prof

CONTACT

maja.sos@siol.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Masking the infusion mixture by using the same shape of the drug/placebo bottle and wrapping it into non-transparent sheath.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, double blind, placebo controlled

Study Record Dates

• First Submitted: August 18, 2019
• First Posted: August 20, 2019
• Study Start: October 14, 2019
• Primary Completion: November 1, 2021
• Study Completion: May 1, 2022
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After the collection of data has finished.
• Access Criteria: Primary researcher consent.

Locations

SL (1)