Comparison of Continuous ESP Versus TEA After Thoracotomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Erector spinae plane block group; Procedure: Thoracic epidural analgesia group

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hojin Lee, MD; Phone Number: 82-2-2072-0039; Email: zenerdiode03@gmail.com
• Study Contact Backup: Name: Susie Yoon, MD, PhD; Phone Number: 82-2-2072-2467; Email: susiey87@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, KS013
    • Recruiting
    • Seoul National University Hospital
    • Contact: Hojin Lee, MD; Phone Number: 82-2-2072-2467; Email: zenerdiode03@gmail.com
    • Contact: Susie Yoon, MD, PhD; Phone Number: 82-2-2072-2467; Email: susiey87@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erector spinae plane block group (ESP group); 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; 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); Other Names: ESP group
Active Comparator: Thoracic epidural analgesia group (TEA group); 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; 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); Other Names: TEA group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2021
• Primary Completion (Anticipated): December 30, 2025
• Study Completion (Anticipated): February 28, 2026

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: lung cancer; nerve block; thoracotomy; interfascial plane block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2104-142-1214

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No