Anesthesia, ConductionNCT03718377
The Effects of Ultrasound-guided Serratus Plane Block During Video-assisted Thoracoscopic Lobectomy
A study testing Serratus plane block and General anesthesia only in people with Anesthesia, Conduction and Pain Management, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
This study evaluates the effects of serratus 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
- Anesthesia, Conduction, Pain Management
- What is being tested?
- Serratus plane block and General anesthesia only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Aug 2018to Jun 2019
- 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
- American Society of Anesthesiologists physical status classification I-III for three port video-assisted thoracic surgery lobectomy under general anesthesia
Who cannot join
- History of allergic reaction to local anesthetics, coagulopathy, local infection at the injection site, and systemic infection.
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: The Effects of Ultrasound-guided Serratus Plane Block in Combination With General Anesthesia on Intraoperative Opioid Consumption, Emergence Time and Hemodynamic Stability During Video-assisted Thoracoscopic Lobectomy
This study evaluates the effects of serratus 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. It has been reported to be used for pain management including rib fracture, herpes zoster, and postoperative pain. It has become a popular analgesic modality because it is easy to perform and relatively safe. However, the effect of serratus plane block during intraoperative period has not yet been studied.
In this study, therefore, the investigators decided to assess the effect of serratus plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.
- Conditions
- Anesthesia, Conduction, Pain Management
- Being tested
- Serratus plane block, General anesthesia only
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus plane blockProcedure or surgery
The subjects were received serratus plane block in the regional-anesthesia unit out of operation room before induction of general anesthesia. And, video-assisted thoracic surgery was performed under balanced general anesthesia.
General anesthesia onlyProcedure or surgery
Video-assisted thoracic surgery was performed under balanced general anesthesia without serratus plane block
| Study group | Role | What they receive |
|---|---|---|
| Serratus plane block | Experimental | The subjects were received serratus plane block in the regional-anesthesia unit out of operation room before induction of general anesthesia. And, video-assisted thoracic surgery was performed under balanced general anesthesia. Receives: Procedure: Serratus plane block |
| General anesthesia only | Active comparator | Video-assisted thoracic surgery was performed under balanced general anesthesia without serratus plane block Receives: Procedure: General anesthesia only |
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 (4)
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start28 Aug 2018
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, ConductionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 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
- NCT03718377
- Sponsor's protocol ID
- 2018-06-006-002
- Status last verified
- Feb 2019
- First submitted
- 18 Oct 2018
- Last updated
- 27 Feb 2019
- 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 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ultrasound-guided Serratus Plane Block in Combination With General Anesthesia on Intraoperative Opioid Consumption, Emergence Time and Hemodynamic Stability During Video-assisted Thoracoscopic Lobectomy
- ClinicalTrials.gov ID
- NCT03718377
- Acronym / sponsor ID
- 2018-06-006-002
- Conditions
- Anesthesia, Conduction, Pain Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 24 Oct 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.
This study evaluates the effects of serratus 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. It has been reported to be used for pain management including rib fracture, herpes zoster, and postoperative pain. It has become a popular analgesic modality because it is easy to perform and relatively safe. However, the effect of serratus plane block during intraoperative period has not yet been studied.
In this study, therefore, the investigators decided to assess the effect of serratus 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
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus plane block | Experimental | Procedure: Serratus plane blockThe subjects were received serratus plane block in the regional-anesthesia unit out of operation room before induction of general anesthesia. And, video-assisted thoracic surgery was performed under balanced general anesthesia. |
| General anesthesia only | Active comparator | Procedure: General anesthesia onlyVideo-assisted thoracic surgery was performed under balanced general anesthesia without serratus plane block |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status classification I-III for three port video-assisted thoracic surgery lobectomy under general anesthesia
Key exclusion criteria (1 listed)
- History of allergic reaction to local anesthetics, coagulopathy, local infection at the injection site, and systemic infection.
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 |
|---|---|---|
| Serratus plane blockThe subjects were received serratus plane block in the regional-anesthesia unit out of operation room before induction of general anesthesia. And, video-assisted thoracic surgery was performed under balanced general anesthesia. | Procedure or surgery | Serratus plane block |
| General anesthesia onlyVideo-assisted thoracic surgery was performed under balanced general anesthesia without serratus plane block | Procedure or surgery | General anesthesia only |
Primary outcome
Intraoperative remifentanil consumption
Time frame: through study completion, an average of 1 year
Intraoperative remifentanil consumption will be checked.
4 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
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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 Serratus plane block and General anesthesia only in people with Anesthesia, Conduction and Pain Management, 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 1 inclusion and 1 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 27 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. 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 27 Feb 2019.