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NCT Number: NCT05008614

Comparison of Continuous ESP Versus TEA After Thoracotomy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, KS013, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: 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)

Other names: TEA group

Primary outcomes

  1. Maximum postoperative pain score at rest on postoperative day 1

    Time frame: Maximum pain score among the 9 am and 4 pm measurements on postoperative day 1

    pain score measured by the 11-pointed numeric rating scale (0: none/10: worst pain)

Secondary outcomes

  1. Postoperative pain score at rest

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

    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

  2. Postoperative pain score at movement

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

    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

  3. Change in the total consumption (ml) of patient-controlled analgesia

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

    total consumption (ml) of epidural or erector spinae plane patient-controlled analgesia

  4. Change in the quality of recovery-15 scale from baseline to postoperative day 3

    Time frame: Day before surgery and 4pm on postoperative day 3

    measured by the Korean version of the quality of recovery-15

  5. Postoperative pulmonary function test

    Time frame: 3 months after surgery

    measured at outpatient clinic

  6. Incidence of chronic postoperative pain

    Time frame: 3 months after surgery

    measure by the Korean version of the pain DETECT

  7. Incidence of chronic postoperative pain

    Time frame: 6 months after surgery

    measure by the Korean version of the pain DETECT

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2021
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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