Postoperative PainNCT05008614
Comparison of Continuous ESP Versus TEA After Thoracotomy
A study testing Erector spinae plane block group and Thoracic epidural analgesia group in people with Postoperative Pain, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Erector spinae plane block group and Thoracic epidural analgesia group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jul 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia After Thoracotomy: A Randomized Controlled Assessor-blinded Non-inferiority Trial
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Erector spinae plane block group, Thoracic epidural analgesia group
- Keywords
- thoracotomy, lung cancer, interfascial plane block, nerve block
- Medical subject headings
- Pain, Postoperative, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane block groupProcedure or surgery
Also called ESP 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 groupProcedure or surgery
Also called TEA 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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: Thoracic epidural analgesia group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Maximum pain score among the 9 am and 4 pm measurements on postoperative day 1
Secondary outcomes (7)
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
Measured: 9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on 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
Measured: 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
total consumption (ml) of epidural or erector spinae plane patient-controlled analgesia
Measured: 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
measured by the Korean version of the quality of recovery-15
Measured: Day before surgery and 4pm on postoperative day 3
Postoperative pulmonary function test
measured at outpatient clinic
Measured: 3 months after surgery
Incidence of chronic postoperative pain
measure by the Korean version of the pain DETECT
Measured: 3 months after surgery
Incidence of chronic postoperative pain
measure by the Korean version of the pain DETECT
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start22 Jul 2021
- Primary completion15 May 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective randomized controlled assessor-blinded non-inferiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University
- Responsible party
- Principal investigator, Susie Yoon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008614
- Sponsor's protocol ID
- 2104-142-1214
- Status last verified
- May 2025
- First submitted
- 3 Aug 2021
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia After Thoracotomy: A Randomized Controlled Assessor-blinded Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05008614
- Acronym / sponsor ID
- 2104-142-1214
- Conditions
- Postoperative Pain
- Keywords
- thoracotomy, lung cancer, interfascial plane block, nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective randomized controlled assessor-blinded non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block group (ESP group) | Experimental | Procedure: Erector spinae plane block groupPatients 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) |
| Thoracic epidural analgesia group (TEA group) | Active comparator | Procedure: Thoracic epidural analgesia groupPatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector spinae plane block groupAlso: ESP groupBefore 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) | Procedure or surgery | Erector spinae plane block group (ESP group) |
| Thoracic epidural analgesia groupAlso: TEA groupBefore 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) | Procedure or surgery | Thoracic epidural analgesia group (TEA group) |
Primary outcome
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)
7 secondary outcomes
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
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 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
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
Postoperative pulmonary function test
Time frame: 3 months after surgery
Incidence of chronic postoperative pain
Time frame: 3 months after surgery
Incidence of chronic postoperative pain
Time frame: 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
Related trials for Postoperative Pain
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block group and Thoracic epidural analgesia group in people with Postoperative Pain, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.