Postoperative Analgesia With a Catheter Under the Erector Spinae Muscle for Videothoracoscopic Lung Surgery - Clinical Trial for Neoplasm of Lung | NCT04665531

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Slovenia

Study Type

Interventional

Intervention

Erector Spinae Catheter

Intercostal block

Ropivacaine 0.2% Injectable Solution

About this trial

This is an interventional treatment trial for Neoplasm of Lung focused on measuring Anesthesia, Conduction, Regional Anesthesia, Post-operative Analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Surgery Bitenc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A - Erector Spinae Catheter group

Group B - Intercostal block

Arm Description

Patients in the experimental group will receive the erector spinae catheter prior the surgery and will be administered local anesthetics for 48 hours post-operatively. Anesthetic regimen: initial bolus of 20ml 0.5% levobupivacaine before the end of surgery. Then continually ropivacaine 0,2% 5ml/h with intermittent boluses 15ml ropivacaine 0,2% every 4h. Both groups will receive multimodal analgetic treatment consisting of a patient-controlled (PCA) pump with opioid analgetics and a peripherally acting analgetic metamizol on a regular basis. The PCA pump will be set to intermittent boluses of 3mg piritramide with a lock-out time 15 min and a maximal number of 6 boluses /3 hours. Patients will receive metamizol 2,5g/12hours i.v. on the day of surgery and 500-1000mg / 6 hours orally on the first and second post-operative day.

Patients will receive standard treatment, i.e. the multi-level intercostal block administered at the end of the surgery by the surgeon. They will receive 20ml 0,5% levobupivacaine on 6 levels of the thoracic wall according to the operative wound level. Both groups will receive multimodal analgetic treatment consisting of a patient-controlled (PCA) pump with opioid analgetics and a peripherally acting analgetic metamizol on a regular basis. The PCA pump will be set to intermittent boluses of 3mg piritramide with a lock-out time 15 min and a maximal number of 6 boluses /3 hours. Patients will receive metamizol 2,5g/12hours i.v. on the day of surgery and 500-1000mg / 6 hours orally on the first and second post-operative day.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04665531

First Posted

November 11, 2020

Last Updated

July 18, 2022

Sponsor

Surgery Bitenc

1. Study Identification

Unique Protocol Identification Number

NCT04665531

Brief Title

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

Acronym

ESCAV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

February 19, 2020 (Actual)

Primary Completion Date

March 14, 2022 (Actual)

Study Completion Date

June 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Surgery Bitenc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasm of Lung, Thoracic Surgery, Video-Assisted

Keywords

Anesthesia, Conduction, Regional Anesthesia, Post-operative Analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Prospective, randomised, controlled

Masking

ParticipantOutcomes Assessor

Masking Description

The method of treatment is obvious and cannot be masked for care providers and investigators. Data will be non-labelled and therefore concealed before the outcomes assessor.

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A - Erector Spinae Catheter group

Arm Type

Experimental

Arm Description

Patients in the experimental group will receive the erector spinae catheter prior the surgery and will be administered local anesthetics for 48 hours post-operatively. Anesthetic regimen: initial bolus of 20ml 0.5% levobupivacaine before the end of surgery. Then continually ropivacaine 0,2% 5ml/h with intermittent boluses 15ml ropivacaine 0,2% every 4h. Both groups will receive multimodal analgetic treatment consisting of a patient-controlled (PCA) pump with opioid analgetics and a peripherally acting analgetic metamizol on a regular basis. The PCA pump will be set to intermittent boluses of 3mg piritramide with a lock-out time 15 min and a maximal number of 6 boluses /3 hours. Patients will receive metamizol 2,5g/12hours i.v. on the day of surgery and 500-1000mg / 6 hours orally on the first and second post-operative day.

Arm Title

Group B - Intercostal block

Arm Type

Active Comparator

Arm Description

Patients will receive standard treatment, i.e. the multi-level intercostal block administered at the end of the surgery by the surgeon. They will receive 20ml 0,5% levobupivacaine on 6 levels of the thoracic wall according to the operative wound level. Both groups will receive multimodal analgetic treatment consisting of a patient-controlled (PCA) pump with opioid analgetics and a peripherally acting analgetic metamizol on a regular basis. The PCA pump will be set to intermittent boluses of 3mg piritramide with a lock-out time 15 min and a maximal number of 6 boluses /3 hours. Patients will receive metamizol 2,5g/12hours i.v. on the day of surgery and 500-1000mg / 6 hours orally on the first and second post-operative day.

Intervention Type

Procedure

Intervention Name(s)

Erector Spinae Catheter

Other Intervention Name(s)

continuous regional analgesia

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Intercostal block

Other Intervention Name(s)

Single shot regional analgesia

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Ropivacaine 0.2% Injectable Solution

Intervention Description

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.

Primary Outcome Measure Information:

Title

Demand for opioid analgetics

Description

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.

Time Frame

Continually 48 hours after surgery

Title

Difference in pre- and post-operative respiratory muscle fitness

Description

Investigators will compare the change between pre- and post-operative main inspiratory pressure and main expiratory pressure measurements between the two research groups.

Time Frame

First postoperative day

Title

Difference in pre- and post-operative respiratory muscle fitness

Description

Investigators will compare the change between pre- and post-operative main inspiratory pressure and main expiratory pressure measurements between the two research groups.

Time Frame

Second postoperative day

Secondary Outcome Measure Information:

Title

Subjective pain score

Description

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.

Time Frame

Every hour in the 48 hours post surgery.

Other Pre-specified Outcome Measures:

Title

Number of patients with late post-operative complications

Description

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.

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Polona Gams

Organizational Affiliation

Surgery Bitenc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Surgery Bitenc

City

Golnik

ZIP/Postal Code

4204

Country

Slovenia

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

26509324

Citation

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

Results Reference

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PubMed Identifier

18443635

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.

Results Reference

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PubMed Identifier

28526156

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.

Results Reference

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PubMed Identifier

30304509

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(R)) 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.

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PubMed Identifier

30233861

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.

Results Reference

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PubMed Identifier

28217054

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.

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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. No abstract available.

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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.

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Results Reference

background

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

Neoplasm of Lung, Thoracic Surgery, Video-Assisted

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial