Pain ManagementNCT04252378
Ultrasound-guided Deep and Superficial Serratus Anterior Plane Block
A study testing Deep Serratus Anterior Plane Block and Superficial Serratus Anterior Plane Block in people with Pain Management and Thoracotomy, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
This study evaluates the difference of deep and superficial serratus anterior plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pain Management, Thoracotomy
- What is being tested?
- Deep Serratus Anterior Plane Block and Superficial Serratus Anterior Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jul 2019to 31 Mar 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a) American Society of Anesthesiologists (ASA) physical status 1 or 2
- b) age 20-75 years
- c) elective three port Video-assisted thoracoscopic surgery (VATS) lobectomy.
Who cannot join
- a) a history of drug allergy for opioids or local anesthetics
- b) local infection at the injection site and systemic infection
- c) coagulopathy
- d) difficulty in understanding the study protocol
- e) refusal to participate
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyungpook national university hospital
Daegu, 700-412
Jimin Heo, 82-53-420-5430, knuhmrc@knu.ac.kr
About this study
Official title: Comparison of Intraoperative Opioid Consumption, Emergence Time and Hemodynamic Stability Between Ultrasound-guided Deep and Superficial Serratus Anterior Plane Block During Video-assisted Thoracoscopic Lobectomy
This study evaluates the difference of deep and superficial serratus anterior plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.
Read the detailed description
Thoracotomy is known as one of the most painful surgery. Thus, there is a development to reduce surgical stress in terms of operation technique, which is video-assisted thoracoscopic surgery. Although it has reduced postoperative pain and complications compared with thoracotomy, VATS is still quite painful operation. Serratus plane block is a novel technique which provide analgesic effect for lateral chest wall by blocking lateral branch of intercostal nerve. Two methods were proposed to target the top and bottom of the serratus anterior muscle. However, the difference of deep and superficial serratus anterior plane block during intraoperative period has not yet been studied.
In this study, therefore, the investigators decided to assess the difference of deep and superficial serratus anterior plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.
- Conditions
- Pain Management, Thoracotomy
- Being tested
- Deep Serratus Anterior Plane Block, Superficial Serratus Anterior Plane Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Serratus Anterior Plane BlockProcedure or surgery
Deep Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance.
Superficial Serratus Anterior Plane BlockProcedure or surgery
Superficial Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance.
| Study group | Role | What they receive |
|---|---|---|
| Deep Serratus Anterior Plane Block | Experimental | Deep Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance. 20ml of 0.375% ropivacaine was slowly injected between the fascia of serratus anterior and external intercostal muscle near 5th rib. Receives: Procedure: Deep Serratus Anterior Plane Block |
| Superficial Serratus Anterior Plane Block | Active comparator | Superficial Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance. 20ml of 0.375% ropivacaine was slowly injected between the fascia of serratus anterior and latissimus dorsi near 5th rib. Receives: Procedure: Superficial Serratus Anterior Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative remifentanil consumption
Intraoperative remifentanil consumption will be checked.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Emergence time
Emergence time is duration between the end of surgery and extubation. Emergence time will be checked.
Measured: through study completion, an average of 1 year
Systolic blood pressure
Systolic blood pressure (mmHg) will be checked
Measured: through study completion, an average of 1 year
Heart rate (HR) Heart rate
Heart rate (beats per minute) will be checked
Measured: through study completion, an average of 1 year
Dose of rescue drugs used to control blood pressure and HR
Dose of rescue drugs used to control blood pressure and HR will be checked
Measured: through study completion, an average of 1 year
Postoperative pain: numeric rating scale
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
Measured: 30 minutes later operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Jul 2019
- Primary completion29 Feb 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saeyoung Kim, MD, PhD, Kyungpook National University Hospital
- Investigators
- Saeyoung Kim, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252378
- Sponsor's protocol ID
- 2019-05-003-001
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraoperative Opioid Consumption, Emergence Time and Hemodynamic Stability Between Ultrasound-guided Deep and Superficial Serratus Anterior Plane Block During Video-assisted Thoracoscopic Lobectomy
- ClinicalTrials.gov ID
- NCT04252378
- Acronym / sponsor ID
- 2019-05-003-001
- Conditions
- Pain Management, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 29 Feb 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 5 Feb 2020 (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 study evaluates the difference of deep and superficial serratus anterior plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.
Detailed description
Thoracotomy is known as one of the most painful surgery. Thus, there is a development to reduce surgical stress in terms of operation technique, which is video-assisted thoracoscopic surgery. Although it has reduced postoperative pain and complications compared with thoracotomy, VATS is still quite painful operation. Serratus plane block is a novel technique which provide analgesic effect for lateral chest wall by blocking lateral branch of intercostal nerve. Two methods were proposed to target the top and bottom of the serratus anterior muscle. However, the difference of deep and superficial serratus anterior plane block during intraoperative period has not yet been studied.
In this study, therefore, the investigators decided to assess the difference of deep and superficial serratus anterior plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Serratus Anterior Plane Block | Experimental | Procedure: Deep Serratus Anterior Plane BlockDeep Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance. 20ml of 0.375% ropivacaine was slowly injected between the fascia of serratus anterior and external intercostal muscle near 5th rib. |
| Superficial Serratus Anterior Plane Block | Active comparator | Procedure: Superficial Serratus Anterior Plane BlockSuperficial Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance. 20ml of 0.375% ropivacaine was slowly injected between the fascia of serratus anterior and latissimus dorsi near 5th rib. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a) American Society of Anesthesiologists (ASA) physical status 1 or 2
- b) age 20-75 years
- c) elective three port Video-assisted thoracoscopic surgery (VATS) lobectomy.
Key exclusion criteria (5 listed)
- a) a history of drug allergy for opioids or local anesthetics
- b) local infection at the injection site and systemic infection
- c) coagulopathy
- d) difficulty in understanding the study protocol
- e) refusal to participate
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 |
|---|---|---|
| Deep Serratus Anterior Plane BlockDeep Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance. | Procedure or surgery | Deep Serratus Anterior Plane Block |
| Superficial Serratus Anterior Plane BlockSuperficial Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance. | Procedure or surgery | Superficial Serratus Anterior Plane Block |
Primary outcome
Intraoperative remifentanil consumption
Time frame: through study completion, an average of 1 year
Intraoperative remifentanil consumption will be checked.
5 secondary outcomes
Emergence time
Time frame: through study completion, an average of 1 year
Systolic blood pressure
Time frame: through study completion, an average of 1 year
Heart rate (HR) Heart rate
Time frame: through study completion, an average of 1 year
Dose of rescue drugs used to control blood pressure and HR
Time frame: through study completion, an average of 1 year
Postoperative pain: numeric rating scale
Time frame: 30 minutes later operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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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.
Saeyoung Kim principal investigator
Kyungpook National University 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 Deep Serratus Anterior Plane Block and Superficial Serratus Anterior Plane Block in people with Pain Management and Thoracotomy, run by Kyungpook 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 3 inclusion and 5 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 5 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jimin Heo (+82-53-420-5430, knuhmrc@knu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative remifentanil consumption (time frame: through study completion, an average of 1 year). 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 5 Feb 2020.