Lung DiseasesNCT03682354
ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery
A study testing Intercostal Nerve Block with PCIA and Erector Spinae Plane Block (ESPB) in people with Lung Diseases, run by Peking University Third Hospital at 1 site in China.
Trial summary
A randomized prospective trial to test the non-inferiority of erector spinae plane block (ESPB) in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in Thoracoscopic lung surgery Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Intercostal Nerve Block with PCIA and Erector Spinae Plane Block (ESPB)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2018to 15 Mar 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients to receive video assisted thoracoscopic lobectomy or bullectomy .
Who cannot join
- 1. Patient refusal 2. Heavy skin eruption and infection at site of injection. 3. Coagulopathy. 4. Allergy to local anesthetics. 5. Taking analgesics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block Versus Intercostal Nerve Block Combined With Patient-controlled Intravenous Analgesia in Video-assisted Thoracic Surgery
A randomized prospective trial to test the non-inferiority of erector spinae plane block (ESPB) in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in Thoracoscopic lung surgery
Read the detailed description
For patients undergoing thoracic surgery, postoperative pain greatly limited their recovery.Multimodal analgesia have shown good efficacy but without reaching full pain relief.
The primary goal of this study is to observe the effect of ultrasound-guided erector spinae plane block in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in video assisted thoracic lung surgery.
- Conditions
- Lung Diseases
- Being tested
- Intercostal Nerve Block with PCIA, Erector Spinae Plane Block (ESPB)
- Keywords
- Erector spinae plane block, Video-assisted thoracic surgery;, Intercostal nerve block, Patient-controlled intravenous analgesia
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercostal Nerve Block with PCIADrug
Intercostal nerve block consists in the injection of Ropivacaine (4 ml,0.5%) in related intercostal spaces. Patient-controlled intravenous analgesia regimen is conducted with sufentanil.
Erector Spinae Plane Block (ESPB)Drug
Erector Spinae Plane Block consists in the injection of Ropivacaine (20ml, 0.5%), in the anatomical plane between the Erector Spinae muscles and transverse process, laterally to the spinous process of T5 . The catheter was inserted and secured in place under ecographic guidance, and a patient-controlled regional anesthesia regimen was conducted with 0.2% ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Intercostal Nerve Block with PCIA | Active comparator | Intercostal Nerve Block with patient-controlled intravenous analgesia Receives: Drug: Intercostal Nerve Block with PCIA |
| Erector Spinae Plane Block (ESPB) | Experimental | Continuous Erector Spinae Plane Block Receives: Drug: Erector Spinae Plane Block (ESPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score (NRS)
Numeric Rating Scale is an 11-point scale used by doctors to evaluate patients' pain, where 0 is no pain and 10 the worst imaginable pain. For postoperative patients, an higher score shows inadequate analgesia and worse outcome.
Measured: 4 hours from the end of procedure
Secondary outcomes (3)
Pain score (NRS)
Numeric Rating Scale is an 11-point scale used by doctors to evaluate patients' pain, where 0 is no pain and 10 the worst imaginable pain. For postoperative patients, an higher score shows inadequate analgesia and worse outcome.
Measured: 8, 24,48 hours from the end of procedure
Analgesics consumption
Analgesics include opioids and nonsteroidal anti-inflammatory drugs
Measured: During operation,4, 8, 24,48 hours from the end of procedure
Incidence of side effects and complication during study
Side effects and complication
Measured: During operation,4, 8, 24,48 hours from the end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start27 Sep 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Li, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682354
- Sponsor's protocol ID
- M2018123
- Status last verified
- Mar 2019
- First submitted
- 26 Aug 2018
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang T, Wang X, Yu Z, Li M. Programmed Intermittent Bolus for Erector Spinae Plane Block Versus Intercostal Nerve Block With Patient-controlled Intravenous Analgesia in Video-assisted Thoracoscopic Surgery: A Randomized Controlled Noninferiority Trial. Clin J Pain. 2024 Feb 1;40(2):99-104. doi: 10.1097/AJP.0000000000001174.
PubMed 37975501
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Intercostal Nerve Block Combined With Patient-controlled Intravenous Analgesia in Video-assisted Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03682354
- Acronym / sponsor ID
- M2018123
- Conditions
- Lung Diseases
- Keywords
- Erector spinae plane block, Video-assisted thoracic surgery;, Intercostal nerve block, Patient-controlled intravenous analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 24 Sep 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.
A randomized prospective trial to test the non-inferiority of erector spinae plane block (ESPB) in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in Thoracoscopic lung surgery
Detailed description
For patients undergoing thoracic surgery, postoperative pain greatly limited their recovery.Multimodal analgesia have shown good efficacy but without reaching full pain relief.
The primary goal of this study is to observe the effect of ultrasound-guided erector spinae plane block in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in video assisted thoracic lung surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intercostal Nerve Block with PCIA | Active comparator | Drug: Intercostal Nerve Block with PCIAIntercostal Nerve Block with patient-controlled intravenous analgesia |
| Erector Spinae Plane Block (ESPB) | Experimental | Drug: Erector Spinae Plane Block (ESPB)Continuous Erector Spinae Plane Block |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients to receive video assisted thoracoscopic lobectomy or bullectomy .
Key exclusion criteria (1 listed)
- 1. Patient refusal 2. Heavy skin eruption and infection at site of injection. 3. Coagulopathy. 4. Allergy to local anesthetics. 5. Taking analgesics.
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 |
|---|---|---|
| Intercostal Nerve Block with PCIAIntercostal nerve block consists in the injection of Ropivacaine (4 ml,0.5%) in related intercostal spaces. Patient-controlled intravenous analgesia regimen is conducted with sufentanil. | Drug | Intercostal Nerve Block with PCIA |
| Erector Spinae Plane Block (ESPB)Erector Spinae Plane Block consists in the injection of Ropivacaine (20ml, 0.5%), in the anatomical plane between the Erector Spinae muscles and transverse process, laterally to the spinous process of T5 . The catheter was inserted and secured in place under ecographic guidance, and a patient-controlled regional anesthesia regimen was conducted with 0.2% ropivacaine. | Drug | Erector Spinae Plane Block (ESPB) |
Primary outcome
Pain score (NRS)
Time frame: 4 hours from the end of procedure
Numeric Rating Scale is an 11-point scale used by doctors to evaluate patients' pain, where 0 is no pain and 10 the worst imaginable pain. For postoperative patients, an higher score shows inadequate analgesia and worse outcome.
3 secondary outcomes
Pain score (NRS)
Time frame: 8, 24,48 hours from the end of procedure
Analgesics consumption
Time frame: During operation,4, 8, 24,48 hours from the end of procedure
Incidence of side effects and complication during study
Time frame: During operation,4, 8, 24,48 hours from the end of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Derived from this study: PubMed 37975501Wang T, Wang X, Yu Z, Li M. Programmed Intermittent Bolus for Erector Spinae Plane Block Versus Intercostal Nerve Block With Patient-controlled Intravenous Analgesia in Video-assisted Thoracoscopic Surgery: A Randomized Controlled Noninferiority Trial. Clin J Pain. 2024 Feb 1;40(2):99-104. doi: 10.1097/AJP.0000000000001174.
- 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.
Min Li study chair
Peking University Third 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 Intercostal Nerve Block with PCIA and Erector Spinae Plane Block (ESPB) in people with Lung Diseases, run by Peking University Third Hospital at 1 site in China.
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: finished, as of the sponsor's last update on 27 Mar 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (NRS) (time frame: 4 hours from the end of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682354, which also lists 1 linked publication.
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 Mar 2019.