Erector Spinae Muscle Plane BlockANESSTEVATSNCT04538235
Analgesic Non Inferiority of the Thoracic Bi-block in Comparison With Thoracic Epidural for VATS.
An observational study of Erector Spinae Muscle Plane Block and Serratus Anterior Muscle Plane Block, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Video-Assisted thoracic surgery (VATS) is the standard treatment for localized lung cancer. However, there is no consensus on analgesic management in patients undergoing VATS. The aim of the study is to compare the analgesic efficacy of thoracic epidural with that a "Bi-block" combining an Erector Spinae muscle plane… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erector Spinae Muscle Plane Block, Serratus Anterior Muscle Plane Block, Video-Assisted Thoracic Surgery
- What is being tested?
- Thoracic Regional Analgesia
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2019to 31 Dec 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Each patient enrolled in the Bi-block group were matched by age, gender and type of surgery with two controls in the TEA group. Patients not-matched were secondarily excluded.
Who may be able to join
- To be over 18.
- To be scheduled for VATS in the center of the study during the study period.
- Thoracic Epidural analgesia of Bi-block analgesia.
Who cannot join
- Chronic pain or opioid use before surgery (6 months).
- Postoperative hospitalization in ICU during the first two days.
- Postoperative surgical complication needing surgical revision during the first two days.
- Preoperative dementia or other psychiatric disease incompatible with VAS pain scoring.
Trial locations and contacts
1 site in 1 country.
France1 site
Intensive Care Unit, D - University hospital of Montpellier
Montpellier, 34295
About this study
Official title: Analgesic Non Inferiority of the Thoracic Bi-block Combining an Erector Spinae Muscle Plane Block and a Serratus Anterior Muscle Plane Block in Comparison With Thoracic Epidural for Video-Assisted Thoracic Surgery.
Video-Assisted thoracic surgery (VATS) is the standard treatment for localized lung cancer. However, there is no consensus on analgesic management in patients undergoing VATS.
The aim of the study is to compare the analgesic efficacy of thoracic epidural with that a "Bi-block" combining an Erector Spinae muscle plane Block (ESP) and a Serratus Anterior Block (SAP) in patients undergoing VATS for lung or pleural surgery.
Our main hypothesis is that the analgesic efficacy of the Bi-block, assessed by morphine consumption, is not inferior to that provided by a thoracic epidural during the first 48 hours after VATS. We conducted a age, gender and type of surgery-matched retrospective cohort study in the Department of Thoracic Anesthesia of the Montpellier University Hospital (France).
- Conditions
- Erector Spinae Muscle Plane Block, Serratus Anterior Muscle Plane Block, Video-Assisted Thoracic Surgery, Lung Cancer, Pleural Diseases, Thoracic Epidural
- Being tested
- Thoracic Regional Analgesia
- Keywords
- regional anesthesia, video-assisted thoracic surgery
- Medical subject headings
- Lung Neoplasms, Pleural Diseases, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Regional AnalgesiaProcedure or surgery
Also called Thoracic Epidural Analgesia, Bi-block, a regional anesthesia technique combining a serratus anterior block with an erector spinae block
In the TEA group, a thoracic epidural was performed before VATS. In the Bi-block group, a SAP block associated with an ESP block were performed before surgical incision under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Bi-block (Serratus and erector spinae block) group | The Bi-block consisted in performing an ESP block followed by a SAP block on the side ipsilateral to the thoracic surgery. For the ESP block, 40 ml of Ropivacaine 2mg/ml were injected under the erector spinae muscle plane, at the level of the 4th thoracic vertebra. For the SAP block, 40 ml of Ropivacaine 2 mg/ml were injected under the serratus anterior muscle plane. The cumulative dose of Ropivacaine did not exceed 3 mg/kg.
Regional anesthesia was performed before surgery. Receives: Procedure: Thoracic Regional Analgesia | |
| Thoracic Epidural Analgesia (TEA) group | The thoracic epidural was performed according to a standardized protocol, with a Tuohy needle via the median puncture technique, at the level of T4-T5 intervertebral space. After a test dose of 2 to 3 ml of Lidocaine, 5 to 10 ml of a mixture of Ropivacaine 2 mg/ml and Sufentanil 0.5 µg / mL were injected. Epidural continuous administration was performed with the same mixture of anesthetic connected to a CADD Solis ™ pump set according to a PCEA protocol adapted to the patient's weight (continuous flow rate from 3 to 6 ml/h, self-administered bolus dose from 3 to 5 ml, refractory period 30 min).
Regional anesthesia was performed before surgery. Receives: Procedure: Thoracic Regional Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative morphine consumption on postoperative day 2
cumulative morphine consumption on postoperative day 2, including the morphine administered in Post anesthesia care unit (PACU), on postoperative day 0, 1 and 2.
Measured: postoperative day 2
Secondary outcomes (7)
non-opioid analgesics consumption on postoperative day 2
Paracetamol, Tramadol, Ketoprofen, Nefopam cumulative consumption on POD 2.
Measured: postoperative day 2
Pain assessed by visual analog pain scale (VAS)
mean VAS, maximal VAS, number of events with a VAS > 3
Measured: up to postoperative day 2
Urinary retention
Measured: up to postoperative day 2
hypotension
Measured: up to postoperative day 2
pleural drain duration
Measured: up to postoperative day 2
duration of hospitalization
Measured: up to postoperative day 2
occurrence of prurit
Measured: up to postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start20 Oct 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Muscle Plane BlockStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Sentenac, MD, Principal investigator, University Hospital, MontpellierPascal H Colson, MD, PhD, Study chair, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538235
- Sponsor's protocol ID
- RECHMPL19_0473
- Acronym
- ANESSTEVATS
- Status last verified
- Sep 2020
- First submitted
- 2 Sep 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Non Inferiority of the Thoracic Bi-block Combining an Erector Spinae Muscle Plane Block and a Serratus Anterior Muscle Plane Block in Comparison With Thoracic Epidural for Video-Assisted Thoracic Surgery.
- ClinicalTrials.gov ID
- NCT04538235
- Acronym / sponsor ID
- ANESSTEVATS / RECHMPL19_0473
- Conditions
- Erector Spinae Muscle Plane Block, Serratus Anterior Muscle Plane Block, Video-Assisted Thoracic Surgery, Lung Cancer, Pleural Diseases, Thoracic Epidural
- Keywords
- regional anesthesia, video-assisted thoracic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Sep 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.
Video-Assisted thoracic surgery (VATS) is the standard treatment for localized lung cancer. However, there is no consensus on analgesic management in patients undergoing VATS.
The aim of the study is to compare the analgesic efficacy of thoracic epidural with that a "Bi-block" combining an Erector Spinae muscle plane Block (ESP) and a Serratus Anterior Block (SAP) in patients undergoing VATS for lung or pleural surgery.
Our main hypothesis is that the analgesic efficacy of the Bi-block, assessed by morphine consumption, is not inferior to that provided by a thoracic epidural during the first 48 hours after VATS. We conducted a age, gender and type of surgery-matched retrospective cohort study in the Department of Thoracic Anesthesia of the Montpellier University Hospital (France).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bi-block (Serratus and erector spinae block) group | – | Procedure: Thoracic Regional AnalgesiaThe Bi-block consisted in performing an ESP block followed by a SAP block on the side ipsilateral to the thoracic surgery. For the ESP block, 40 ml of Ropivacaine 2mg/ml were injected under the erector spinae muscle plane, at the level of the 4th thoracic vertebra. For the SAP block, 40 ml of Ropivacaine 2 mg/ml were injected under the serratus anterior muscle plane. The cumulative dose of Ropivacaine did not exceed 3 mg/kg. Regional anesthesia was performed before surgery. |
| Thoracic Epidural Analgesia (TEA) group | – | Procedure: Thoracic Regional AnalgesiaThe thoracic epidural was performed according to a standardized protocol, with a Tuohy needle via the median puncture technique, at the level of T4-T5 intervertebral space. After a test dose of 2 to 3 ml of Lidocaine, 5 to 10 ml of a mixture of Ropivacaine 2 mg/ml and Sufentanil 0.5 µg / mL were injected. Epidural continuous administration was performed with the same mixture of anesthetic connected to a CADD Solis ™ pump set according to a PCEA protocol adapted to the patient's weight (continuous flow rate from 3 to 6 ml/h, self-administered bolus dose from 3 to 5 ml, refractory period 30 min). Regional anesthesia was performed before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Each patient enrolled in the Bi-block group were matched by age, gender and type of surgery with two controls in the TEA group. Patients not-matched were secondarily excluded.
Key inclusion criteria (3 listed)
- To be over 18.
- To be scheduled for VATS in the center of the study during the study period.
- Thoracic Epidural analgesia of Bi-block analgesia.
Key exclusion criteria (4 listed)
- Chronic pain or opioid use before surgery (6 months).
- Postoperative hospitalization in ICU during the first two days.
- Postoperative surgical complication needing surgical revision during the first two days.
- Preoperative dementia or other psychiatric disease incompatible with VAS pain scoring.
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 |
|---|---|---|
| Thoracic Regional AnalgesiaAlso: Thoracic Epidural Analgesia, Bi-block, a regional anesthesia technique combining a serratus anterior block with an erector spinae blockIn the TEA group, a thoracic epidural was performed before VATS. In the Bi-block group, a SAP block associated with an ESP block were performed before surgical incision under general anesthesia. | Procedure or surgery | Bi-block (Serratus and erector spinae block) group, Thoracic Epidural Analgesia (TEA) group |
Primary outcome
cumulative morphine consumption on postoperative day 2
Time frame: postoperative day 2
cumulative morphine consumption on postoperative day 2, including the morphine administered in Post anesthesia care unit (PACU), on postoperative day 0, 1 and 2.
7 secondary outcomes
non-opioid analgesics consumption on postoperative day 2
Time frame: postoperative day 2
Pain assessed by visual analog pain scale (VAS)
Time frame: up to postoperative day 2
Urinary retention
Time frame: up to postoperative day 2
hypotension
Time frame: up to postoperative day 2
pleural drain duration
Time frame: up to postoperative day 2
duration of hospitalization
Time frame: up to postoperative day 2
occurrence of prurit
Time frame: up to postoperative day 2
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 4 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Pierre Sentenac, MD principal investigator
University Hospital, Montpellier
Pascal H Colson, MD, PhD study chair
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erector Spinae Muscle Plane Block and Serratus Anterior Muscle Plane Block, run by University Hospital, Montpellier at 1 site in France.
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 4 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 4 Sep 2020. 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 France. 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?
cumulative morphine consumption on postoperative day 2 (time frame: postoperative day 2). 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 4 Sep 2020.