Comparison of Continuous ESP Versus TEA After Thoracotomy

NCT05008614 | Completed DMC

• 1 other identifier: 2104-142-1214
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

thoracotomy; lung cancer; interfascial plane block; nerve block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Postoperative pain score at rest

  9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3

• Postoperative pain score at movement

  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

  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

  Day before surgery and 4pm on postoperative day 3

• Postoperative pulmonary function test

  3 months after surgery

Study Arms (2)

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)

Procedure: Erector spinae plane block group

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)

Procedure: Thoracic epidural analgesia group

Interventions

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)

Also known as: ESP group

Erector spinae plane block group (ESP group)

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)

Also known as: TEA group

Thoracic epidural analgesia group (TEA group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, KS013, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative; Lung Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor not involved in this study will investigate the outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant clinical professor

Model Details: A prospective randomized controlled assessor-blinded non-inferiority trial

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 17, 2021
• Study Start: July 22, 2021
• Primary Completion: May 15, 2024
• Study Completion: December 31, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

KR (1)