Comparison of Continuous ESP Versus TEA After Thoracotomy

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05008614
• Other study ID #: 2104-142-1214
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2021
• Est. completion date: February 28, 2026

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: Hojin Lee, MD
• Phone: 82-2-2072-0039
• Email: zenerdiode03[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: February 28, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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)
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Postoperative pulmonary function test	measured at outpatient clinic	3 months after surgery
Secondary	Incidence of chronic postoperative pain	measure by the Korean version of the pain DETECT	3 months after surgery
Secondary	Incidence of chronic postoperative pain	measure by the Korean version of the pain DETECT	6 months after surgery