Comparison of Continuous ESP Versus TEA After Thoracotomy

Seoul National University

Status: Enrolling

Conditions: Postoperative Pain

Treatments: Procedure: Erector spinae plane block group; Procedure: Thoracic epidural analgesia group

Study type: Interventional

Funder types: Other

Identifiers

NCT05008614

2104-142-1214

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Erector spinae plane block group (ESP group)

Experimental group

Description:

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)

Treatment:

Procedure: Erector spinae plane block group

Thoracic epidural analgesia group (TEA group)

Active Comparator group

Description:

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)

Treatment:

Procedure: Thoracic epidural analgesia group