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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
A ultrasound guided single bolus injection of 20 ml of levobupivacaine or placebo between the erector spinae muscle and process transversus of vertebra T5.
St Antonius Hospital
Nieuwegein, Utrecht, Netherlands
Pain intensity (numeric rating scale (NRS) (0=no pain up to 10=most pain imaginable) 2 hours after surgery.
Pain level 2 hours after surgery
Time frame: 2 hours postoperatively
Pain intensity (NRS) 4 hours after surgery.
Pain level 4 hours after surgery
Time frame: 4 hours postoperatively
Pain intensity (NRS) 8 hours after surgery.
Pain level 8 hours after surgery
Time frame: 8 hours postoperatively
Pain intensity (NRS) 12 hours after surgery.
Pain level twelve hours after surgery
Time frame: 12 hours postoperatively
Pain intensity (NRS) at 8.00 o'clock on the first postoperative day
Pain level at 8.00 o'clock on the first postoperative day
Time frame: At 8 o'clock AM on the first postoperative day
Pain intensity (NRS) at 20.00 o'clock on the first postoperative day
Pain level at 20.00 o'clock on the first postoperative day
Time frame: At 8 o'clock PM on the first postoperative day
Opioid consumption
Parenteral morphine use (mg) as recorded by the Patient-Controlled Analgesia (PCA) device
Time frame: First 48 hours after surgery, recorded following disconnection of the PCA device at 8 o'clock AM on the second postoperative day.
length of stay in recovery ward (minutes)
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length of stay in recovery ward (minutes) after surgery
Time frame: First 48 hours after surgery
Patient satisfaction of pain therapy
Patient satisfaction of pain therapy (numeric rating scale 0-10(0=severely dissatisfied up to 10= maximally satisfied)
Time frame: Measurement in the morning of the second postoperative day
Presence of side effects
Daily scoring of side effects (nausea, drowsiness, pruritus, other (yes/no))
Time frame: First 48 hours