Clinical trial NCT04751552: Erector Spinae Block for Thoracoscopic Surgery
Official title: Effect of Erector Spinae Plane Block on Postoperative Pain Intensity in Patients Undergoing Thoracoscopic Surgery: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Thoracic Neoplasms
Keywords: Thoracoscopy
Pain
Regional anaesthesia
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled double blind trial
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial compares the effects of the erector spinae plane block with levobupivacaine and 0,9% saline on postoperative pain intensity, and opioid consumptions following thoracoscopic pulmonary surgery.

Detailed description: Sixty patients planned for thoracoscopic pulmonary surgery are randomly assigned to an erector spinae plane block (ESPB) with levobupivacaine (intervention group) or 0,9% saline (control group). ESPB is performed under general anaesthesia before surgery.

Postoperative pain medication incudes acetominophen, NSAIDs en parenteral morphine (patient controlled analgesia).

Following surgery pain intensity (numeric rating scale) is registered at the recovery ward one hour after surgery. Furthermore, pain intensity is registered 2,4,8, 12 hours after the operation. On the first postoperative day, pain intensity is registered at 8.00 o'cock AM and 8.00 o'clock PM. Opioid consumption is registered as a second parameter of postoperative pain.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for thoracoscopic pulmonary sleeve resection or lobectomy
* Age 18 years or older

  * American Society of Anesthesiologists (ASA) health status class I-III
  * Informed consent

Exclusion Criteria:

* Contraindication for regional analgesia (e.g. coagulopathy, infection at injection site)
* Contraindication for NSAIDs
* Chronic opioid use
* Pregnancy

Primary outcomes:
measure: Pain intensity (numeric rating scale (NRS) (0=no pain up to 10=most pain imaginable) 2 hours after surgery.
timeFrame: 2 hours postoperatively
measure: Pain intensity (NRS) 4 hours after surgery.
timeFrame: 4 hours postoperatively
measure: Pain intensity (NRS) 8 hours after surgery.
timeFrame: 8 hours postoperatively
measure: Pain intensity (NRS) 12 hours after surgery.
timeFrame: 12 hours postoperatively
Secondary outcomes:
measure: Pain intensity (NRS) at 8.00 o'clock on the first postoperative day
timeFrame: At 8 o'clock AM on the first postoperative day
measure: Pain intensity (NRS) at 20.00 o'clock on the first postoperative day
timeFrame: At 8 o'clock PM on the first postoperative day
measure: Opioid consumption
timeFrame: First 48 hours after surgery, recorded following disconnection of the PCA device at 8 o'clock AM on the second postoperative day.
measure: length of stay in recovery ward (minutes)
timeFrame: First 48 hours after surgery
measure: Patient satisfaction of pain therapy
timeFrame: Measurement in the morning of the second postoperative day
measure: Presence of side effects
timeFrame: First 48 hours
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
state: Utrecht
Study officials:
References: