Comparison of Continuous ESP Versus TEA After Thoracotomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia After Thoracotomy: A Randomized Controlled Assessor-blinded Non-inferiority Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Erector spinae plane block group
* Procedure: Thoracic epidural analgesia group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo elective thoracotomy for lung cancer European Cooperative Oncology Group 0 or 1 American Society of Anesthesiologists (ASA) physical classification I-III Willingness and ability to sign an informed consent document Exclusion Criteria: patients with chronic postoperative pain after thoracic surgery patients undergoing thoracotomy with chest wall resection allergies to anesthetic or analgesic medications patients with coagulopathy or who continue to take anticoagulants preoperative liver or renal dysfunction patients with chronic pain, chronic opioid, analgesic or antidepressant or anticonvulsant use Do not understand our study Medical or psychological disease that can affect the treatment response

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective randomized controlled assessor-blinded non-inferiority trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erector spinae plane block group (ESP group)<br>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) | Procedure: Erector spinae plane block group<br>* 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)<br>* Other names: ESP group;|
| Active Comparator: Thoracic epidural analgesia group (TEA group)<br>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) | Procedure: Thoracic epidural analgesia group<br>* 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)<br>* Other names: TEA group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracotomy, lung cancer, interfascial plane block, nerve block