Post-operative Pain, AcuteNCT05242328
Postoperative Analgesia y After Uniportal Video-assisted Thoracoscopic Surgery
A study testing Ultrasound-guided erector spinae plane block and surgical thoracoscopic intercostal nerve block in people with Post-operative Pain, Acute and Post-operative Pain, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Ultrasound-guided erector spinae plane block (ESPB) is an interfascial blockade during thoracic anesthesia, first described by Forero in 2016, and is highlighted by technically feasibility and less complication rate. The patient is placed as decubitus position. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Post-operative Pain, Acute, Post-operative Pain, Thoracic Diseases
- What is being tested?
- Ultrasound-guided erector spinae plane block and surgical thoracoscopic intercostal nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jan 2021to 26 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, over 20 years old, u
- undergoing elective uniportal VATS lobectomy.
Who cannot join
- patient refusal,
- body mass index > 35 kg/m2,
- American society of anesthesiologists (ASA) grade above 3,
- contraindication to nerve block,
- allergy to analgesic agents,
- regular opioid used for chronic pain prior to this time surgery,
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- conversion to thoracotomy or VATS procedure,
- postoperative intubation,
- postoperative intensive care unit admission.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan
Shuoying Dai, MD, +886-6-2353535 ext. 5182, hsnu_10@yahoo.com.te
About this study
Official title: Comparison of Surgical Thoracoscopic Intercostal Nerve Block and Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia and Enhanced Recovery After Uniportal Video-assisted Thoracoscopic Surgery: a Double-blinded, Randomized Controlled Trial
Ultrasound-guided erector spinae plane block (ESPB) is an interfascial blockade during thoracic anesthesia, first described by Forero in 2016, and is highlighted by technically feasibility and less complication rate. The patient is placed as decubitus position. The anesthesiologists use echo to identify the ipsilateral transverse process at T5 level, and insert the needle to 2-3 cm lateral to the spinous process until contact the transverse process. Then the injected local anesthetic will penetrate via erector spinae muscle to paravertebral space to affect and relieve pain.
- Being tested
- Ultrasound-guided erector spinae plane block, surgical thoracoscopic intercostal nerve block
- Keywords
- Uniportal video-assisted thoracoscopic surgery, Ultrasound-guided erector spinae plane block, surgical thoracoscopic intercostal nerve block, cumulative intravenous morphine consumption, visual analogue scale, Enhanced Recovery After Surgery
- Medical subject headings
- Pain, Postoperative, Thoracic Diseases, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided erector spinae plane blockProcedure or surgery
Ultrasound-guided erector spinae plane block
surgical thoracoscopic intercostal nerve blockProcedure or surgery
surgical thoracoscopic intercostal nerve block
| Study group | Role | What they receive |
|---|---|---|
| post-operative VAS score of Ultrasound-guided erector spinae plane block | Active comparator | Not described Receives: Procedure: Ultrasound-guided erector spinae plane block |
| post-operative VAS score of surgical thoracoscopic intercostal nerve block | Active comparator | Not described Receives: Procedure: surgical thoracoscopic intercostal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
post-op VAS score, 0-10, the higher means painful, and "0" point no pain.
Measured: post-op 2 days
accumulated morphine usage dose
accumulated morphine usage dose
Measured: post-op 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start5 Jan 2021
- Primary completion26 Dec 2024 (estimated)
- Study completion26 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuoying Dai, Study chair, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242328
- Sponsor's protocol ID
- A-ER-110-293
- Status last verified
- Dec 2022
- First submitted
- 26 Jan 2022
- Last updated
- 27 Feb 2023
- 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 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Thoracoscopic Intercostal Nerve Block and Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia and Enhanced Recovery After Uniportal Video-assisted Thoracoscopic Surgery: a Double-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05242328
- Acronym / sponsor ID
- A-ER-110-293
- Keywords
- Uniportal video-assisted thoracoscopic surgery, Ultrasound-guided erector spinae plane block, surgical thoracoscopic intercostal nerve block, cumulative intravenous morphine consumption, visual analogue scale, Enhanced Recovery After Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 26 Dec 2024 (estimated)
- Study completion
- 26 Dec 2024 (estimated)
- First posted
- 16 Feb 2022 (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.
Ultrasound-guided erector spinae plane block (ESPB) is an interfascial blockade during thoracic anesthesia, first described by Forero in 2016, and is highlighted by technically feasibility and less complication rate. The patient is placed as decubitus position. The anesthesiologists use echo to identify the ipsilateral transverse process at T5 level, and insert the needle to 2-3 cm lateral to the spinous process until contact the transverse process. Then the injected local anesthetic will penetrate via erector spinae muscle to paravertebral space to affect and relieve pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post-operative VAS score of Ultrasound-guided erector spinae plane block | Active comparator | Procedure: Ultrasound-guided erector spinae plane block |
| post-operative VAS score of surgical thoracoscopic intercostal nerve block | Active comparator | Procedure: surgical thoracoscopic intercostal nerve block |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients, over 20 years old, u
- undergoing elective uniportal VATS lobectomy.
Key exclusion criteria (9 listed)
- patient refusal,
- body mass index > 35 kg/m2,
- American society of anesthesiologists (ASA) grade above 3,
- contraindication to nerve block,
- allergy to analgesic agents,
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 |
|---|---|---|
| Ultrasound-guided erector spinae plane blockUltrasound-guided erector spinae plane block | Procedure or surgery | post-operative VAS score of Ultrasound-guided erector spinae plane block |
| surgical thoracoscopic intercostal nerve blocksurgical thoracoscopic intercostal nerve block | Procedure or surgery | post-operative VAS score of surgical thoracoscopic intercostal nerve block |
Primary outcome
Visual analogue scale
Time frame: post-op 2 days
post-op VAS score, 0-10, the higher means painful, and "0" point no pain.
accumulated morphine usage dose
Time frame: post-op 2 days
accumulated morphine usage dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
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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.
Shuoying Dai study chair
National Cheng-Kung 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 Ultrasound-guided erector spinae plane block and surgical thoracoscopic intercostal nerve block in people with Post-operative Pain, Acute and Post-operative Pain, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 9 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 2023. 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 Taiwan. 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 Shuoying Dai, MD (+886-6-2353535 ext. 5182, hsnu_10@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: post-op 2 days). 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 27 Feb 2023.