Erector Spinae Plane Block versus Thoracic Epidural Block in Elective Video-Assisted Thoracic Surgery (VATS): A Prospective Randomized Open Label non-inferiority Trial

Recruiting

Conditions: Postoperative pain treatment
Regional analgesia
10038666
10029107

Registration Number: NL-OMON48927

Lead Sponsor: Catharina-ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

(1) Age between 18 and 75 years,
(2) BMI between 18 and 30kg/m2,
(3) scheduled for elective VATS surgery, and
(4) written informed consent.

Exclusion Criteria

(1) ASA status***4
(2) chronic opioid use (> 3 months of strong opioids, weak opioids such as
tramadol are allowed)
(3) renal or liver failure inhibiting the systematic use of paracetamol and/or
NSAIDs
(4) contraindication for epidural analgesia (e.g. INR or platelets according to
local protocol, local infection at the surgery site or puncture site)
(5) allergy to study medication
(6) pregnancy
(7) cognitive impairment
(8) insufficient comprehension of the Dutch QoR-15 questionnaire.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of this study is the QoR15 on POD 0,1 and 2</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are Visual Analog Scales (VAS) score on POD 0,1 and 2<br /><br>(assessed at rest and when moving (coughing) in the morning and in the<br /><br>evening), Length of hospital stay (LOS), failure of analgesic technique<br /><br>(defined as catheter failure, need for specialist intervention and/ or need for<br /><br>rescue medication), the postoperative morphine-equivalent consumption on POD<br /><br>0,1 and 2, itching, nausea and vomiting, the total operative time (recorded as<br /><br>total time spent in the operating room, anesthetic time, surgical time),<br /><br>complications related to surgery (e.g. conversion to open procedure),<br /><br>perioperative hypotension (requiring prolonged use of vasopressors)<br /><br>complications related to pain treatment (e.g. epidural hematoma or local<br /><br>anesthetic toxicity) duration of bladder catheterization, first mobilization<br /><br>(to chair and > 20 meters) </p><br>