Pain, PostoperativeNCT03777592
Perioperative Erector Spinae Plane Block in Thoracoscopic Surgery
A study testing erector spinae plane block in people with Pain, Postoperative and Regional Block, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
The erector spinae plane block (ESPB) is a novel myofascial plane block. The ESPB is targeted at anterior surface of the erector spinae plane, which is oriented cephalocaudally to the spinal transverse process. Local anaesthetic injected in this plane can block the dorsal rami and ventral rami and intercostal nerves. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Pain, Postoperative, Regional Block
- What is being tested?
- erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Dec 2018to Nov 2020
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists Patients with physical class 1, 2
- Patients undergoing video assisted thoracoscopic surgery
Who cannot join
- Patients who experienced side effects on local anesthetics
- Patients with abnormal blood coagulation tests (INR> 1.5)
- Pregnant or lactating patients
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
KangbukSamsung Hospital
Seoul, 03181
Sung Hyun Lee, MD
About this study
Official title: Correlation Between Perioperative Erector Spinae Plane Block and Postoperative Pain in Thoracoscopic Surgery
The erector spinae plane block (ESPB) is a novel myofascial plane block. The ESPB is targeted at anterior surface of the erector spinae plane, which is oriented cephalocaudally to the spinal transverse process. Local anaesthetic injected in this plane can block the dorsal rami and ventral rami and intercostal nerves. The aim of this study was to evaluate the effect of ESPB on postoperative pain in thoracic surgery.
Read the detailed description
The erector spinae plane block (ESPB) is a newly defined regional anesthesia technique for thoracic analgesia. The blocks were performed at the T5 level of the spine using an in-plane approach.Previous studies were not designed as randomized controlled trial. In this study, the efficacy of ESPB is to confirm with randomized controlled trial design. ESPB will be performed in video assisted thoracoscopy preoperatively. After the surgery, the efficacy of ESPB will be assessed.
- Conditions
- Pain, Postoperative, Regional Block
- Being tested
- erector spinae plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane blockProcedure or surgery
local anesthetic or saline is administered in to the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces
| Study group | Role | What they receive |
|---|---|---|
| ESPB with local agent | Active comparator | ESPB will be performed using 20ml of 0.5% ropivacaine. Receives: Procedure: erector spinae plane block |
| ESPB with saline | Sham comparator | ESPB will be performed using 20ml of saline. Receives: Procedure: erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scale
11-point numeric rating scale(
(Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)
Measured: the first 5 min after arriving at the recovery room
Pain scale
11-point numeric rating scale (Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)
Measured: 20 min after arriving at the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start15 Dec 2018
- Primary completionJun 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Hyun Lee, Kangbuk Samsung Hospital
- Investigators
- Sung Hyun Lee, MD, Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777592
- Sponsor's protocol ID
- 2018-09-017-001
- Status last verified
- Feb 2019
- First submitted
- 12 Dec 2018
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Perioperative Erector Spinae Plane Block and Postoperative Pain in Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT03777592
- Acronym / sponsor ID
- 2018-09-017-001
- Conditions
- Pain, Postoperative, Regional Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 17 Dec 2018 (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.
The erector spinae plane block (ESPB) is a novel myofascial plane block. The ESPB is targeted at anterior surface of the erector spinae plane, which is oriented cephalocaudally to the spinal transverse process. Local anaesthetic injected in this plane can block the dorsal rami and ventral rami and intercostal nerves. The aim of this study was to evaluate the effect of ESPB on postoperative pain in thoracic surgery.
Detailed description
The erector spinae plane block (ESPB) is a newly defined regional anesthesia technique for thoracic analgesia. The blocks were performed at the T5 level of the spine using an in-plane approach.Previous studies were not designed as randomized controlled trial. In this study, the efficacy of ESPB is to confirm with randomized controlled trial design. ESPB will be performed in video assisted thoracoscopy preoperatively. After the surgery, the efficacy of ESPB will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB with local agent | Active comparator | Procedure: erector spinae plane blockESPB will be performed using 20ml of 0.5% ropivacaine. |
| ESPB with saline | Sham comparator | Procedure: erector spinae plane blockESPB will be performed using 20ml of saline. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists Patients with physical class 1, 2
- Patients undergoing video assisted thoracoscopic surgery
Key exclusion criteria (3 listed)
- Patients who experienced side effects on local anesthetics
- Patients with abnormal blood coagulation tests (INR> 1.5)
- Pregnant or lactating patients
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 blocklocal anesthetic or saline is administered in to the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces | Procedure or surgery | ESPB with local agent, ESPB with saline |
Primary outcome
Pain scale
Time frame: the first 5 min after arriving at the recovery room
11-point numeric rating scale( (Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)
Pain scale
Time frame: 20 min after arriving at the recovery room
11-point numeric rating scale (Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Sung Hyun Lee, MD principal investigator
Kangbuk Samsung Hospital
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 in people with Pain, Postoperative and Regional Block, run by Kangbuk Samsung 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Feb 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Hyun Lee, MD (82-2-2001-2323, 4321hoho@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scale (time frame: the first 5 min after arriving at the recovery room). The study lists 2 primary outcomes in all. 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 28 Feb 2019.