Comparison of Continuous ESP Versus TEA After Thoracotomy

Not Applicable

Recruiting

• Conditions: Postoperative Pain
• Interventions: Procedure: Thoracic epidural analgesia group; Procedure: Erector spinae plane block group

• Registration Number: NCT05008614
• Lead Sponsor: Seoul National University Hospital

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.

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 Timeline

• Study Start: 2021-07-22
• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-09
• Study First Posted: 2021-08-17
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13
• Primary Completion: 2025-12-30
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracic epidural analgesia group (TEA group)	Thoracic epidural analgesia 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)
Erector spinae plane block group (ESP group)	Erector spinae plane block 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)

Primary Outcome Measures

Name	Time	Method
Maximum postoperative pain score at rest on postoperative day 1	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 Outcome Measures

Name	Time	Method
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	total consumption (ml) of epidural or erector spinae plane patient-controlled analgesia
Postoperative pulmonary function test	3 months after surgery	measured at outpatient clinic
Change in the quality of recovery-15 scale from baseline to postoperative day 3	Day before surgery and 4pm on postoperative day 3	measured by the Korean version of the quality of recovery-15
Postoperative pain score at rest	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
Incidence of chronic postoperative pain	6 months after surgery	measure by the Korean version of the pain DETECT
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 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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of