Thoracic SurgeryNCT04024683
The Effect of the Ultrasound-guided Serratus Anterior Plane Block in Combinaison With Thoracic Paravertebral cathéter Versus Thoracic Paravertebral Cather for Perioperative Analgesia in Thoracic Surgery
An observational study of Thoracic Surgery, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Introduction The paravertebral catheter has been shown to be effective in controlling postoperative pain, but has never been associated with the deep dentate block in thoracic surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Serratus block with ropivacaine 2mg/ml
- Type of treatment
- Surgery or procedure
- How many people
- 159 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 1 Jun 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 to 100 years
- All sexes
- Adult, Older adult
Study population: patients with thoracic surgery in the operating theater of Dijon University Hospital
Who may be able to join
- We included all patients over the age of 18 who met the classification criteria of the American Society of Anesthesiology (ASA) and had thoracic surgery in the operating theater of Dijon University Hospital
Who cannot join
- Exclusion criteria were ASA 4 or higher, pregnant or breastfeeding women, minor patients, patients not able to use morphine PCA, and patients with chronic algia.
Trial locations and contacts
1 site in 1 country.
About this study
Introduction
The paravertebral catheter has been shown to be effective in controlling postoperative pain, but has never been associated with the deep dentate block in thoracic surgery. The objective of this study was to compare the efficacy of single-dose deep dentate block-level postoperative pain control in combination with a continuous perfusion paravertebral catheter versus continuous perfusion paravertebral catheter alone in controlled thoracic surgery.
Read more
Materials and methods
We retrospectively included 159 ASA I-III major patients who underwent scheduled thoracic surgery in the operating theater of Dijon University Hospital, between March and November 2018. All patients benefited from the same anesthetic protocol routinely used in controlled thoracic surgery. They were included in two groups: deep serrate deep group (GS) with a deep serrated deep serrate block immediately after orotracheal intubation with 0.2% Ropivacaine at 0.75 mg / kg and paravertebral catheter placed by the surgeon and put in charge at the fall of the surgical drapes versus control group (GC) benefiting from a paravertebral catheter alone. The primary endpoint was 24-hour morphine equivalent consumption. The criteria for secondary judgments were intraoperative remifentanil consumption, VAS at 0h, 24h and 48h, morphine consumption at 0h, 48h and the profile of the various complications. The morphine equivalent was calculated according to an equivalence table with reference to Oxycodone per os. Quantitative data are presented in median and standard deviation and were compared by Student's t-test or Wilcoxon test.
- Conditions
- Thoracic Surgery
- Being tested
- Serratus block with ropivacaine 2mg/ml
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus block with ropivacaine 2mg/mlProcedure or surgery
The serratus block was made using a 50 mm needle with ultrasound guidance. It was performed supine, the ultrasound probe identifying the 3, 4 or 5th intercostal space and then the needle was introduced under ultrasound control
| Study group | Role | What they receive |
|---|---|---|
| Serratus block group | Realization of a serratus block and para-vertebral catheter Receives: Procedure: Serratus block with ropivacaine 2mg/ml | |
| Control group | Realization of a para-vertebral catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of morphine equivalence
Measured: 24 hours
Secondary outcomes (4)
intraoperative remifentanil consumption,
Measured: 48 hours
visual analogue scale
Measured: 48 hours
morphine consumption
Measured: 48 hours
intraoperative complications
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Mar 2018
- Primary completion1 Nov 2018
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024683
- Sponsor's protocol ID
- Bouhemad - BEAL 2019
- Status last verified
- Jul 2019
- First submitted
- 15 Jul 2019
- Last updated
- 18 Jul 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 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Ultrasound-guided Serratus Anterior Plane Block in Combinaison With Thoracic Paravertebral cathéter Versus Thoracic Paravertebral Cather for Perioperative Analgesia in Thoracic Surgery
- ClinicalTrials.gov ID
- NCT04024683
- Acronym / sponsor ID
- Bouhemad - BEAL 2019
- Conditions
- Thoracic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 18 Jul 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.
Introduction
The paravertebral catheter has been shown to be effective in controlling postoperative pain, but has never been associated with the deep dentate block in thoracic surgery. The objective of this study was to compare the efficacy of single-dose deep dentate block-level postoperative pain control in combination with a continuous perfusion paravertebral catheter versus continuous perfusion paravertebral catheter alone in controlled thoracic surgery.
Materials and methods
We retrospectively included 159 ASA I-III major patients who underwent scheduled thoracic surgery in the operating theater of Dijon University Hospital, between March and November 2018. All patients benefited from the same anesthetic protocol routinely used in controlled thoracic surgery. They were included in two groups: deep serrate deep group (GS) with a deep serrated deep serrate block immediately after orotracheal intubation with 0.2% Ropivacaine at 0.75 mg / kg and paravertebral catheter placed by the surgeon and put in charge at the fall of the surgical drapes versus control group (GC) benefiting from a paravertebral catheter alone. The primary endpoint was 24-hour morphine equivalent consumption. The criteria for secondary judgments were intraoperative remifentanil consumption, VAS at 0h, 24h and 48h, morphine consumption at 0h, 48h and the profile of the various complications. The morphine equivalent was calculated according to an equivalence table with reference to Oxycodone per os. Quantitative data are presented in median and standard deviation and were compared by Student's t-test or Wilcoxon test.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus block group | – | Procedure: Serratus block with ropivacaine 2mg/mlRealization of a serratus block and para-vertebral catheter |
| Control group | – | –Realization of a para-vertebral catheter |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with thoracic surgery in the operating theater of Dijon University Hospital
Key inclusion criteria (1 listed)
- We included all patients over the age of 18 who met the classification criteria of the American Society of Anesthesiology (ASA) and had thoracic surgery in the operating theater of Dijon University Hospital
Key exclusion criteria (1 listed)
- Exclusion criteria were ASA 4 or higher, pregnant or breastfeeding women, minor patients, patients not able to use morphine PCA, and patients with chronic algia.
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 |
|---|---|---|
| Serratus block with ropivacaine 2mg/mlThe serratus block was made using a 50 mm needle with ultrasound guidance. It was performed supine, the ultrasound probe identifying the 3, 4 or 5th intercostal space and then the needle was introduced under ultrasound control | Procedure or surgery | Serratus block group |
Primary outcome
consumption of morphine equivalence
Time frame: 24 hours
4 secondary outcomes
intraoperative remifentanil consumption,
Time frame: 48 hours
visual analogue scale
Time frame: 48 hours
morphine consumption
Time frame: 48 hours
intraoperative complications
Time frame: Day 5
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 18 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thoracic Surgery, run by Centre Hospitalier Universitaire Dijon 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 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 18 Jul 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 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?
consumption of morphine equivalence (time frame: 24 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 18 Jul 2019.