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Erector Spinae Plane (ESP) Block versus Thoracic Epidural Analgesia (TEA) in Video-Assisted Thoracic Surgery (VATS): A Prospective Randomized Open Label Non-Inferiority Trial

Erector Spinae Plane (ESP) Block versus Thoracic Epidural Analgesia (TEA) in Video-Assisted Thoracic Surgery (VATS): A Prospective Randomized Open Label Non-Inferiority Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22453
Enrollment
90
Registered
2018-03-01
Start date
2020-07-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lungcancer, postoperative pain

Interventions

Patients will be randomized (1:1) to receive either pain treatment with ESP (the study group) or TEA (the control group). Patients in the intervention group receive continuous ESP analgesia (ESP) with

Sponsors

Catharina ziekenhuis Eindhoven
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: (1) Age between 18 and 75 years old, (2) BMI between 20 and 30kg/m 2 , (3) scheduled for elective VATS, and (4) written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria are as follows: (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-40 questionnaire.

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is the QoR15 (See section 6.1.) on POD1 and 2 including subscale analysis Comfort; Emotions, Independence, Support and Pain).

Secondary

MeasureTime frame
Secondary endpoints include - postoperative Visual Analog Scales (VAS) score on day 1 and 2 (assessed at rest and when moving (coughing) in the morning and in the evening) - Length of hospital stay (LOS), - requirement of rescue medication - postoperative morphine-equivalent consumption per day, - failure of analgesic technique (defined as catheter failure, need for specialist intervention and/ or need for rescue medication) (Table 1) - the total operative time (recorded as total time spent in the operating room, anesthetic time, surgical time), - complications related to surgery (e.g. bleeding, surgical site infection, conversion to open procedure), - complications related to pain treatment (e.g. epidural hematoma and abscess or local anesthetic toxicity) - duration of bladder catheterization, - first mobilization to chair and > 20 meters - 30 days post-surgical evaluation by phone of pain, opioid use and patient satisfaction

Contacts

Public ContactR.A. Bouwman
arthur.bouwman@catharinaziekenhuis.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)