AnalgesiaNCT04191850
Ultrasound-Guided Serratus Anterior Plane Block in Pneumothorax Surgery
A study testing Single Port Video-Assisted Thoracoscopic Surgery in people with Analgesia and Postoperative Pain, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
A prospective randomized controlled study was undertaken to compare the postoperative analgesic effect between ultrasound-guided serratus anterior plane block and intercostal nerve block after single port video-assisted thoracoscopic surgery with primary spontaneous pneumothorax. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Analgesia, Postoperative Pain, Pneumothorax
- What is being tested?
- Single Port Video-Assisted Thoracoscopic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2018to 31 Jan 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- primary spontaneous pneumothorax
- elective single port video-assisted thoracoscopic wedge resection of the lung.
Who cannot join
- secondary spontaneous pneumothorax
- reoperation in ipsilateral thorax
- a history of drug allergy for analgesics
- participants who have difficulty understanding the study protocol
- refusal of participants
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 the Analgesic Effect Between Ultrasound-Guided Serratus Anterior Plane Block and Intercostal Nerve Block After Single Port Video-Assisted Thoracoscopic Surgery in Primary Spontaneous Pneumothorax
A prospective randomized controlled study was undertaken to compare the postoperative analgesic effect between ultrasound-guided serratus anterior plane block and intercostal nerve block after single port video-assisted thoracoscopic surgery with primary spontaneous pneumothorax.
Read the detailed description
Post-thoracotomy pain is one of the most notorious postsurgical pains that one can experience. The pain is known to last for an extensive period of time with significantly high intensity.
In field of thoracic surgery, video-assisted thoracoscopic surgery has been played an important role in alleviating the postoperative pain. Furthermore, single-port thoracoscopic surgery, which reduces the number of surgical incision, is increasingly carried out by many institutions world widely.
In field of anesthesiology, various attempts to alleviate post-thoracotomy pain have been tried along advancement of thoracic surgical techniques. It began with postoperative medication of non-steroid anti-inflammatory drugs, opioids and progressed into implementations such as local analgesia, thoracic epidural block, paravertebral block, intercostal nerve block, interpleural block and serratus anterior plane block.
Many analgesic methods have been applied to alleviate postoperative pain in patients who have undergone thoracoscopic surgeries. However, there are no prospective randomized controlled studies between intercostal nerve block and serratus anterior plane block in single port video-assisted thoracoscopic surgeries. The main purpose of this study is to compare and analyze the effects between conventional intercostal nerve block and newly introduced serratus anterior plane block in primary spontaneous pneumothorax patients who have undergone single port video-assisted thoracoscopic wedge resection. This prospective study will discover the efficacy and differences between two methods.
- Conditions
- Analgesia, Postoperative Pain, Pneumothorax
- Being tested
- Single Port Video-Assisted Thoracoscopic Surgery
- Medical subject headings
- Agnosia, Pain, Postoperative, Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Port Video-Assisted Thoracoscopic SurgeryProcedure or surgery
Single Port Video-Assisted Thoracoscopic wedge resection was performed for primary spontaneous pneumothorax.
| Study group | Role | What they receive |
|---|---|---|
| Intercostal Nerve Block | Active comparator | Intercostal Nerve Block was performed just before closing the surgical incision while looking directly at the affected intercostal space. 10ml of 0.375% ropivacaine was delivered evenly at anterior and posterior intercostal spaces from the port site. Receives: Procedure: Single Port Video-Assisted Thoracoscopic Surgery |
| Serratus Anterior Plane Block | Experimental | 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: Single Port Video-Assisted Thoracoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 3 hours later operation
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: 6 hours later operation
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: 12 hours later operation
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: After removal of chest tube
Secondary outcomes (2)
Number of analgesics consumption
If the participant has additional analgesic requirement postoperatively, ketorolac 30mg will be injected intravenously when numeric rating scale score is measured as 4-5, and fentanyl 50㎍ is injected when numeric rating scale score is over 6.
Measured: through study completion, an average of 1 year
Amount of analgesics consumption
If the participant has additional analgesic requirement postoperatively, ketorolac 30mg will be injected intravenously when numeric rating scale score is measured as 4-5, and fentanyl 50㎍ is injected when numeric rating scale score is over 6.
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 posted10 Dec 2019
- Study start1 Feb 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 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 Saeyoung, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191850
- Sponsor's protocol ID
- 2017-12-012-001
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effect Between Ultrasound-Guided Serratus Anterior Plane Block and Intercostal Nerve Block After Single Port Video-Assisted Thoracoscopic Surgery in Primary Spontaneous Pneumothorax
- ClinicalTrials.gov ID
- NCT04191850
- Acronym / sponsor ID
- 2017-12-012-001
- Conditions
- Analgesia, Postoperative Pain, Pneumothorax
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 10 Dec 2019 (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.
A prospective randomized controlled study was undertaken to compare the postoperative analgesic effect between ultrasound-guided serratus anterior plane block and intercostal nerve block after single port video-assisted thoracoscopic surgery with primary spontaneous pneumothorax.
Detailed description
Post-thoracotomy pain is one of the most notorious postsurgical pains that one can experience. The pain is known to last for an extensive period of time with significantly high intensity.
In field of thoracic surgery, video-assisted thoracoscopic surgery has been played an important role in alleviating the postoperative pain. Furthermore, single-port thoracoscopic surgery, which reduces the number of surgical incision, is increasingly carried out by many institutions world widely.
In field of anesthesiology, various attempts to alleviate post-thoracotomy pain have been tried along advancement of thoracic surgical techniques. It began with postoperative medication of non-steroid anti-inflammatory drugs, opioids and progressed into implementations such as local analgesia, thoracic epidural block, paravertebral block, intercostal nerve block, interpleural block and serratus anterior plane block.
Many analgesic methods have been applied to alleviate postoperative pain in patients who have undergone thoracoscopic surgeries. However, there are no prospective randomized controlled studies between intercostal nerve block and serratus anterior plane block in single port video-assisted thoracoscopic surgeries. The main purpose of this study is to compare and analyze the effects between conventional intercostal nerve block and newly introduced serratus anterior plane block in primary spontaneous pneumothorax patients who have undergone single port video-assisted thoracoscopic wedge resection. This prospective study will discover the efficacy and differences between two methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intercostal Nerve Block | Active comparator | Procedure: Single Port Video-Assisted Thoracoscopic SurgeryIntercostal Nerve Block was performed just before closing the surgical incision while looking directly at the affected intercostal space. 10ml of 0.375% ropivacaine was delivered evenly at anterior and posterior intercostal spaces from the port site. |
| Serratus Anterior Plane Block | Experimental | Procedure: Single Port Video-Assisted Thoracoscopic SurgerySerratus 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
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- primary spontaneous pneumothorax
- elective single port video-assisted thoracoscopic wedge resection of the lung.
Key exclusion criteria (5 listed)
- secondary spontaneous pneumothorax
- reoperation in ipsilateral thorax
- a history of drug allergy for analgesics
- participants who have difficulty understanding the study protocol
- refusal of participants
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 |
|---|---|---|
| Single Port Video-Assisted Thoracoscopic SurgerySingle Port Video-Assisted Thoracoscopic wedge resection was performed for primary spontaneous pneumothorax. | Procedure or surgery | Intercostal Nerve Block, Serratus Anterior Plane Block |
Primary outcome
Postoperative pain: numeric rating scale
Time frame: 3 hours later operation
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
Postoperative pain: numeric rating scale
Time frame: 6 hours later operation
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
Postoperative pain: numeric rating scale
Time frame: 12 hours later operation
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
Postoperative pain: numeric rating scale
Time frame: After removal of chest tube
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
2 secondary outcomes
Number of analgesics consumption
Time frame: through study completion, an average of 1 year
Amount of analgesics consumption
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 10 Dec 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 Saeyoung 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 Single Port Video-Assisted Thoracoscopic Surgery in people with Analgesia and Postoperative Pain, 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 10 Dec 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?
Postoperative pain: numeric rating scale (time frame: 3 hours later operation). The study lists 4 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 10 Dec 2019.