Pain, PostoperativePhase 3ESPAMNCT04400721
Efficacy of an Erector Spinae Plane Block in VATS/RATS
A Phase 3 study testing Erector spinae plane block with ropivacaine 3.75mg/ml in people with Pain, Postoperative and Post-Op Complication, run by Universitair Ziekenhuis Brussel.
Trial summary
This study aims to study the analgesic and respiratory effects of the erector spinae plane block for patients undergoing video-assisted thoracic surgery (VATS) or robotic assisted thoracic surgery (RATS). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pain, Postoperative, Post-Op Complication
- What is being tested?
- Erector spinae plane block with ropivacaine 3.75mg/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 1 Feb 2023
- Phase
- Phase 3
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients
- age between 18 to 100 years old
- ASA 1-3
- scheduled for VATS
- informed consent explained and signed
Who cannot join
- Patients < 18 years old, > 100 years old
- ASA physical status > 3
- previous cardiac surgery or ipsilateral thoracic surgery
- neuropsychiatric diseases
- allergy to analgesics or local anesthetics or other medications used in the study
- abuse of opioids or sedatives
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- contraindication to receive regional anesthesia (e.g. coagulation defect)
- patients who could not understand the VAS pain-scoring system
- patient refusal to follow participation
- expected post operative mechanical ventilation
- intolerance or allergy to any prescribed medication
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of Thoracic Nerve Blocks on Postoperative Pain, Respiratory Function and Recovery in Patients Undergoing Thoracoscopic Surgery
This study aims to study the analgesic and respiratory effects of the erector spinae plane block for patients undergoing video-assisted thoracic surgery (VATS) or robotic assisted thoracic surgery (RATS).
Read the detailed description
A total of 120 subjects will be randomized into three groups (30 per group). Arm A: IV PCIA Arm B: IV PCIA + ultrasound guided Erector spinae block (ESPB, Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine]) Arm C: IV PCIA + multilevel intra-thoracic intercostal nerve block (ICB, Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine]) PCIA pumps for all study cohorts will be programmed according to our institution's standard protocol (Dipidolor [Piritramide] bolus: 2mg, interval: 7 min, max 4h dose: 30mg). The erector spinae block will be placed preoperatively, the intercostal block will be placed at the beginning of the procedure. All patients will receive standard postoperative care. The patients will be blinded for the study arm.
The primary endpoint of this study is postoperative pain and will be recorded by using the numerical rating scale (NRS) pain score. Pain scores will be measured by the investigator at rest and during coughing. Opioid consumption will be monitored and registered for.
- Conditions
- Pain, Postoperative, Post-Op Complication
- Being tested
- Erector spinae plane block with ropivacaine 3.75mg/ml
- Medical subject headings
- Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane block with ropivacaine 3.75mg/mlDrug
Also called Naropin
Single shot erector spinae block
| Study group | Role | What they receive |
|---|---|---|
| PCIA arm | No intervention | Standard post-operative treatment with patient-controlled intravenous analgesia (Piritramide bolus = 2mg, bolus interval = 7 minutes, max 4 hour dose = 30mg) |
| ESP block arm | Active comparator | ultrasound guided Erector spinae block (Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine]) Receives: Drug: Erector spinae plane block with ropivacaine 3.75mg/ml |
| IC block arm | Active comparator | 3 ml of 0.5% solution of Naropin [Ropivacaine] per intercostal space, up to a maximum of 30ml Receives: Drug: Erector spinae plane block with ropivacaine 3.75mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of ESP block in decreasing postoperative pain intensity
Pain levels will be assessed using the 10 points Visual analogue Scale (VAS) where zero= no pain and 10= pain as bad as it can be. The vaS is a validated tool to measure pain and discomfort. It is sensitive to pharmacological and non-pharmacological interventions, that have an impact over the experience of pain, as well as it's high correlation with pain levels
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Jul 2020 (estimated)
- Primary completion28 Jun 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blinded, single-center, randomized, prospective study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400721
- Sponsor's protocol ID
- UZB-VUB-19-01
- Other IDs
- 2019-003534-17, 2019
- Acronym
- ESPAM
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Thoracic Nerve Blocks on Postoperative Pain, Respiratory Function and Recovery in Patients Undergoing Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT04400721
- Acronym / sponsor ID
- ESPAM / UZB-VUB-19-01
- Conditions
- Pain, Postoperative, Post-Op Complication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 28 Jun 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 22 May 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 aims to study the analgesic and respiratory effects of the erector spinae plane block for patients undergoing video-assisted thoracic surgery (VATS) or robotic assisted thoracic surgery (RATS).
Detailed description
A total of 120 subjects will be randomized into three groups (30 per group). Arm A: IV PCIA Arm B: IV PCIA + ultrasound guided Erector spinae block (ESPB, Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine]) Arm C: IV PCIA + multilevel intra-thoracic intercostal nerve block (ICB, Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine]) PCIA pumps for all study cohorts will be programmed according to our institution's standard protocol (Dipidolor [Piritramide] bolus: 2mg, interval: 7 min, max 4h dose: 30mg). The erector spinae block will be placed preoperatively, the intercostal block will be placed at the beginning of the procedure. All patients will receive standard postoperative care. The patients will be blinded for the study arm.
The primary endpoint of this study is postoperative pain and will be recorded by using the numerical rating scale (NRS) pain score. Pain scores will be measured by the investigator at rest and during coughing. Opioid consumption will be monitored and registered for.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Single-blinded, single-center, randomized, prospective study
| Arm | Type | Receives |
|---|---|---|
| PCIA arm | No intervention | –Standard post-operative treatment with patient-controlled intravenous analgesia (Piritramide bolus = 2mg, bolus interval = 7 minutes, max 4 hour dose = 30mg) |
| ESP block arm | Active comparator | Drug: Erector spinae plane block with ropivacaine 3.75mg/mlultrasound guided Erector spinae block (Single shot of 30ml of 0.5% solution of Naropin [Ropivacaine]) |
| IC block arm | Active comparator | Drug: Erector spinae plane block with ropivacaine 3.75mg/ml3 ml of 0.5% solution of Naropin [Ropivacaine] per intercostal space, up to a maximum of 30ml |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients
- age between 18 to 100 years old
- ASA 1-3
- scheduled for VATS
- informed consent explained and signed
Key exclusion criteria (11 listed)
- Patients < 18 years old, > 100 years old
- ASA physical status > 3
- previous cardiac surgery or ipsilateral thoracic surgery
- neuropsychiatric diseases
- allergy to analgesics or local anesthetics or other medications used in the study
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 |
|---|---|---|
| Erector spinae plane block with ropivacaine 3.75mg/mlAlso: NaropinSingle shot erector spinae block | Drug | ESP block arm, IC block arm |
Primary outcome
Efficacy of ESP block in decreasing postoperative pain intensity
Time frame: 48 hours
Pain levels will be assessed using the 10 points Visual analogue Scale (VAS) where zero= no pain and 10= pain as bad as it can be. The vaS is a validated tool to measure pain and discomfort. It is sensitive to pharmacological and non-pharmacological interventions, that have an impact over the experience of pain, as well as it's high correlation with pain levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erector spinae plane block with ropivacaine 3.75mg/ml in people with Pain, Postoperative and Post-Op Complication, run by Universitair Ziekenhuis Brussel.
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 5 inclusion and 11 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 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Domien Vanhonacker, MD (+32494652763, domienvanhonacker@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of ESP block in decreasing postoperative pain intensity (time frame: 48 hours). 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 28 May 2020.