Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine Hcl 0.2% Inj Vil 10Ml | Drug | Group A will receive the medicine through the erector spinae catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Usage of opioid analgetics | Investigators will measure the total consumption of i.v. piritramide after surgery. | Continually 48 hours post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Investigators will follow up the patients in weeks after surgery for possible complications. | 2 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Polona Gams, MD | Contact | 00386 41 522 968 | polona.gams@gmail.com | |
| Maja Šoštarič, MD, as. prof | Contact | maja.sos@siol.net |
| Name | Affiliation | Role |
|---|---|---|
| Polona Gams, MD | Surgery Bitenc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgery Bitenc | Recruiting | Golnik | 4204 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28217054 | Background | 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. | |
| 30233861 | Background | 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. |
Not provided
Not provided
Anonymous IPD may be shared.
After the collection of data has finished.
Primary researcher consent.
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Prospective, randomized, double blind, placebo controlled
Not provided
Not provided
Masking the infusion mixture by using the same shape of the drug/placebo bottle and wrapping it into non-transparent sheath.
| Saline 0.9% | Drug | Group B will receive Saline 0,9% through the erector spinae catheter. |
|
| Every hour in the 48 hours post surgery |
| Incentive spirometry | Investigators will assess spirometry with a manual device. | 24 and 48 hours after surgery |
| Satisfaction with analgesia | Investigators will assess satisfaction with qualitative and quantitative questionnaries. | 1 day (at dismissal from hospital.) |
| 27501016 | 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. |
| 30532584 | 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. |
| 29980005 | 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. |
| 31033625 | 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. |
| 30853517 | 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. |
| 29149734 | 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. |
| 28632673 | 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. |
| 28235492 | 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. |
| 21377888 | 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. |
| 31257829 | 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. |
| 31044575 | 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. |
| 30886130 | Background | Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres 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. |
| 29445595 | 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. |
| 29336785 | Background | 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. |
| 30515044 | 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |