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| Name | Class |
|---|---|
| Seoul National University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erector spinae plane block group (ESP group) | Experimental | Patients receiving continuous unilateral ESP block. Interventions: Procedure: Ultrasound-guided unilateral ESP block via catheter placement for continuous infusion Drug: Ropivacaine 0.75% Injectable Solution Device: 21-gauge 85 mm perineural catheter, 18-gauge 100 mm stimulator needle (Silverstim, Vygon, Ecouen, France) |
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| Thoracic epidural analgesia group (TEA group) | Active Comparator | Patients receiving thoracic epidural analgesia. Interventions: Procedure: Fluoroscopy-guided thoracic epidural analgesia Drug: Ropivacaine 0.75% Injectable Solution Device: 17-gauge Tuohy needle (FlexTip Plus®, Teleflex Medical, USA) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector spinae plane block group | Procedure | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Maximum pain score among the 9 am and 4 pm measurements on postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3 |
| Postoperative pain score at movement |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Seoul | KS013 | South Korea |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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A prospective randomized controlled assessor-blinded non-inferiority trial
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The outcome assessor not involved in this study will investigate the outcomes.
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| Thoracic epidural analgesia group | Procedure | 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) |
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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 |
| 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 | 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 | Day before surgery and 4pm on postoperative day 3 |
| Postoperative pulmonary function test | measured at outpatient clinic | 3 months after surgery |
| Incidence of chronic postoperative pain | measure by the Korean version of the pain DETECT | 3 months after surgery |
| Incidence of chronic postoperative pain | measure by the Korean version of the pain DETECT | 6 months after surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |