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Comparison of Continuous ESP Versus TEA After Thoracotomy

Primary Purpose

Postoperative Pain

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Erector spinae plane block group

Thoracic epidural analgesia group

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring thoracotomy, lung cancer, interfascial plane block, nerve block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Erector spinae plane block group (ESP group)

Thoracic epidural analgesia group (TEA group)

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

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

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

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

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

Postoperative pulmonary function test

measured at outpatient clinic

Incidence of chronic postoperative pain

measure by the Korean version of the pain DETECT

Incidence of chronic postoperative pain

measure by the Korean version of the pain DETECT

Full Information

NCT ID

NCT05008614

First Posted

August 3, 2021

Last Updated

April 11, 2023

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University

1. Study Identification

Unique Protocol Identification Number

NCT05008614

Brief Title

Comparison of Continuous ESP Versus TEA After Thoracotomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 22, 2021 (Actual)

Primary Completion Date

December 30, 2025 (Anticipated)

Study Completion Date

February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

Seoul National University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

thoracotomy, lung cancer, interfascial plane block, nerve block

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A prospective randomized controlled assessor-blinded non-inferiority trial

Masking

Outcomes Assessor

Masking Description

The outcome assessor not involved in this study will investigate the outcomes.

Allocation

Randomized

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Erector spinae plane block group (ESP group)

Arm Type

Experimental

Arm Description

Arm Title

Thoracic epidural analgesia group (TEA group)

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Erector spinae plane block group

Other Intervention Name(s)

ESP group

Intervention Description

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)

Intervention Type

Procedure

Intervention Name(s)

Thoracic epidural analgesia group

Other Intervention Name(s)

TEA group

Intervention Description

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)

Primary Outcome Measure Information:

Title

Maximum postoperative pain score at rest on postoperative day 1

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Postoperative pain score at rest

Description

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

Time Frame

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

Title

Postoperative pain score at movement

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

Day before surgery and 4pm on postoperative day 3

Title

Postoperative pulmonary function test

Description

measured at outpatient clinic

Time Frame

3 months after surgery

Title

Incidence of chronic postoperative pain

Description

measure by the Korean version of the pain DETECT

Time Frame

3 months after surgery

Title

Incidence of chronic postoperative pain

Description

measure by the Korean version of the pain DETECT

Time Frame

6 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hojin Lee, MD

Phone

82-2-2072-0039

zenerdiode03@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Susie Yoon, MD, PhD

Phone

82-2-2072-2467

susiey87@gmail.com

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

KS013

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hojin Lee, MD

Phone

82-2-2072-2467

zenerdiode03@gmail.com

First Name & Middle Initial & Last Name & Degree

Susie Yoon, MD, PhD

Phone

82-2-2072-2467

susiey87@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Comparison of Continuous ESP Versus TEA After Thoracotomy

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