This prospective, randomized, assessor-blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided continuous erector spinae plane (ESP) block in patients undergoing thoracotomy. We hypothesize that US-guided ESP block is not inferior to thoracic epidural analgesia in terms of postoperative pain control in these patients.
Adult patients undergoing elective unilateral thoracotomy for lung cancer resection are randomly allocated to receive US-guided ESP block (n=31) or thoracic epidural analgesia (n=31). Both procedures are performed prior to surgery. Each patient was assessed by a blinded investigator on postoperative day (POD) 1,2 and 3. The primary outcome is pain severity evaluated by a numeric rating scale (NRS) at POD1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
53
Before surgery, an anesthesiologist will perform unilateral ESP block with catheterization under ultrasound guidance in the procedure room. Drug: Ropivacaine 0.75% Injectable Solution 0.2% ropivacaine is continuously infused to the erector spinae plane at T5 level via 18G 85 mm perineural catheter (Silverstim, Vygon, Ecouen, France) (basal infusion: 10ml/hr, bolus 5ml, lockout time: 20min)
Before surgery, an anesthesiologist will perform unilateral ESP block with catheterization under fluoroscopy guidance in the procedure room. Drug: Ropivacaine 0.75% Injectable Solution 0.2% ropivacaine is continuously infused to the erector spinae plane at T5 level via 17-gauge catheter (FlexTip Plus®, Teleflex Medical, USA) (Silverstim, Vygon, Ecouen, France) (basal infusion: 3ml/hr, bolus 1ml, lockout time: 20min)
Seoul National University Hospital
Seoul, Seoul, South Korea
Maximum postoperative pain score at rest on postoperative day 1
pain score measured by the 11-pointed numeric rating scale (0: none/10: worst pain)
Time frame: Maximum pain score among the 9 am and 4 pm measurements on postoperative day 1
Postoperative pain score at rest
Change in the pain score at rest measured by the 11-pointed numeric rating scale (0: none/10: worst pain) from postoperative day 1 to postoperative day 3
Time frame: 9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3
Postoperative pain score at movement
Change in the pain score at movement measured by the 11-pointed numeric rating scale (0: none/10: worst pain) from postoperative day 1 to postoperative day 3
Time frame: 9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3
Change in the total consumption (ml) of patient-controlled analgesia
total consumption (ml) of epidural or erector spinae plane patient-controlled analgesia
Time frame: 9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3
Change in the quality of recovery-15 scale from baseline to postoperative day 3
measured by the Korean version of the quality of recovery-15
Time frame: Day before surgery and 4pm on postoperative day 3
Postoperative pulmonary function test
measured at outpatient clinic
Time frame: 3 months after surgery
Incidence of chronic postoperative pain
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measure by the Korean version of the pain DETECT
Time frame: 3 months after surgery
Incidence of chronic postoperative pain
measure by the Korean version of the pain DETECT
Time frame: 6 months after surgery