Clinical trial NCT04665531: Postoperative Analgesia With a Catheter Under the Erector Spinae Muscle for Videothoracoscopic Lung Surgery
Official title: Postoperative Analgesia With a Catheter Under the Erector Spinae Muscle for Videothoracoscopic Lung Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasm of Lung
Thoracic Surgery, Video-Assisted
Keywords: Anesthesia, Conduction
Regional Anesthesia
Post-operative Analgesia
Lead sponsor: Surgery Bitenc
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomised, controlled
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Demand for opioid analgetics
timeFrame: Continually 48 hours after surgery
measure: Difference in pre- and post-operative respiratory muscle fitness
timeFrame: First postoperative day
measure: Difference in pre- and post-operative respiratory muscle fitness
timeFrame: Second postoperative day
Secondary outcomes:
measure: Subjective pain score
timeFrame: Every hour in the 48 hours post surgery.
Other outcomes:
measure: Number of patients with late post-operative complications
timeFrame: 2 months
Locations:
city: Golnik
country: Slovenia
facility: Surgery Bitenc
Study officials:
affiliation: Surgery Bitenc
name: Polona Gams
role: PRINCIPAL_INVESTIGATOR
References:
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