Postoperative Analgesia With a Catheter Under the Erector Spinae Muscle for Videothoracoscopic Lung Surgery

Thoracic Surgery, Video-Assisted Clinical Trial

— ESCAV  

Official title:

Postoperative Analgesia With a Catheter Under the Erector Spinae Muscle for Videothoracoscopic Lung Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04665531
• Other study ID #: 0120- 372/2019A
• Status: Completed
• Phase: N/A
• Start date: February 19, 2020
• Est. completion date: June 14, 2022

Study information

• Verified date: July 2022
• Source: Surgery Bitenc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the research is to prove the analgesic efficacy of a novel technique in regional anaesthesia, i.e. the catheter under the erector spinae muscle (ESC). Investigators will evaluate the use of the ESC for analgesia after video-assisted thoracoscopic lung surgeries in comparison to the standard method of post-operative analgesia, which is the multiple level intercostal block given at the end of surgery by the surgeon. Investigators will compare the amount of opioid analgesics required by the patient using the patient controlled pump, the pain status in 48-hours after surgery and compare the differences between pre- and post-operative main inspiratory pressure and main expiratory pressure measurements between the two research groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 14, 2022
• Est. primary completion date: March 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed written informed consent

• ASA (American Society of Anesthesiologists status) I-III

• Elective video-assisted thoracic surgery - lobectomy 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

• Inability to execute the main inspiratory and expiratory pressure measurements

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Erector Spinae Catheter
Patients in the experimental group will receive the Erector Spinae Catheter with an initial bolus ob 20ml 0,5% levobupivacaine prior the surgery and will be administered local anesthetics for 48 hours post-operatively.
• Intercostal block
Patients in the comparative group will receive standard treatment, i.e. the multi-level intercostal block with 20ml 0,5% levobupivacaine administered at the end of the surgery by the surgeon.

Drug:
• Ropivacaine 0.2% Injectable Solution
Patients in the experimental group will receive Ropivacaine 0,2% continous infusion of 5ml/h with boluses 15ml/4h by the Erector Spinae Catheter for 48 hours post-operatively.

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 (12)

Adhikary SD, Pruett A, Forero M, Thiruvenkatarajan V. Erector spinae plane block as an alternative to epidural analgesia for post-operative analgesia following video-assisted thoracoscopic surgery: A case study and a literature review on the spread of local anaesthetic in the erector spinae plane. Indian J Anaesth. 2018 Jan;62(1):75-78. doi: 10.4103/ija.IJA_693_17. — View Citation

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

Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS®) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301. Review. — View Citation

Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20. Review. — View Citation

Beverly A, Kaye AD, Ljungqvist O, Urman RD. Essential Elements of Multimodal Analgesia in Enhanced Recovery After Surgery (ERAS) Guidelines. Anesthesiol Clin. 2017 Jun;35(2):e115-e143. doi: 10.1016/j.anclin.2017.01.018. Review. — 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

D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4. 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

Ilfeld BM, Gabriel RA. Basal infusion versus intermittent boluses for perineural catheters: should we take the 'continuous' out of 'continuous peripheral nerve blocks'? Reg Anesth Pain Med. 2019 Mar;44(3):285-286. doi: 10.1136/rapm-2018-100262. Epub 2019 Jan 13. — View Citation

Kamiyoshihara M, Nagashima T, Ibe T, Atsumi J, Shimizu K, Takeyoshi I. Is epidural analgesia necessary after video-assisted thoracoscopic lobectomy? Asian Cardiovasc Thorac Ann. 2010 Oct;18(5):464-8. doi: 10.1177/0218492310381817. — View Citation

Krebs ED, Mehaffey JH, Sarosiek BM, Blank RS, Lau CL, Martin LW. Is less really more? Reexamining video-assisted thoracoscopic versus open lobectomy in the setting of an enhanced recovery protocol. J Thorac Cardiovasc Surg. 2019 Sep 13. pii: S0022-5223(19)31771-4. doi: 10.1016/j.jtcvs.2019.08.036. [Epub ahead of print] — View Citation

Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with late post-operative complications	Investigators will follow up the patients in 4 and 12 weeks after surgery for possible complications. The complications will be read from the follow up documentation in observed patient files. Investigators will search for complications such as arrhythmias, lung or wound infections, lethalities or other unexpected complications.	2 months
Primary	Demand for opioid analgetics	Investigators will measure the total consumption of i.v. piritramide after surgery given by the PCA (patient-controlled analgesia) pump. The PCA pump automatically marks all the drug consumption. The PCA pump will be set to a uniform protocol: piritramide 1mg/ml; flow 0ml/h, bolus 3ml, lockout time 15 min, max 4 boluses / hour.	Continually 48 hours after surgery
Primary	Difference in pre- and post-operative respiratory muscle fitness	Investigators will compare the change between pre- and post-operative main inspiratory pressure and main expiratory pressure measurements between the two research groups.	First postoperative day
Primary	Difference in pre- and post-operative respiratory muscle fitness	Investigators will compare the change between pre- and post-operative main inspiratory pressure and main expiratory pressure measurements between the two research groups.	Second postoperative day
Secondary	Subjective pain score	Investigators will measure subjective perception of pain with the nubmering rating score (NRS) scoring system at resting and coughing. The NRS 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 NRS pain levels.	Every hour in the 48 hours post surgery.