AnesthesiaBSBPNCT04983836
Comparison of Analgesic Efficiency Between Serratus Block and Paravertebral Block in Video-assisted Thoracic Surgery. Double-blind Randomized Comparative Non-inferiority Study (BSBP)
A study testing Serratus anesthesia technique and Paravertebral anesthesia technique in people with Anesthesia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Currently, the 2 main techniques of regional loco anesthesia in perioperative analgesic management of the thoracotomy remains the establishment of a thoracic epidural or paravertebral block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Serratus anesthesia technique and Paravertebral anesthesia technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2021to 15 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Patient who has given their free, informed and signed consent
- Social security affiliation;
Who cannot join
- pregnant woman
- guardianship / curatorship / private patient under public law
- surgery to be performed urgently (less than 24 hours)
- surgery redux
- thoracotomy surgery
- sternotomy surgery
Show all 14Show fewer
- pleurectomy
- patient participating simultaneously in another research that may interfere with results of the study
- severe abnormality of haemostasis (80,000/ml platelets) and/or coagulation (TP 50%, factor V 50%).
- Prior use of morphine;
- chronic pain/chest neuropathies
- sepsis
- patients with insulin-dependent diabetes and/or diabetic neuropathy.
- severe kidney or liver failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgesic Efficiency Between Serratus Block and Paravertebral Block in Video-assisted Thoracic Surgery. Double-blind Randomized Comparative Non-inferiority Study
Currently, the 2 main techniques of regional loco anesthesia in perioperative analgesic management of the thoracotomy remains the establishment of a thoracic epidural or paravertebral block. On the other hand, there is no standard of perioperative analgesic management in the case of thoracic surgery under video-thoracoscopy. The video-thoracoscopy, by its mini-invasive character, makes the levels of pain lower in post-operative questioning the benefit/risk balance of the paravertebral block. In 2013, Blanco published a new technique of locoregional anesthesia called the block Serratus allowing analgesia of a homolateral thorax hemi The latter by its simplicity of realization and its lesser risk is growing in thoracic surgery. This pilot study finds an equivalence in total oxycodone consumption in the first 2 post-operative days with a number of complications related to the serratus block lower than the serratus block compared to the paravertebral block in preoperative surgery.
- Conditions
- Anesthesia
- Being tested
- Serratus anesthesia technique, Paravertebral anesthesia technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus anesthesia techniqueProcedure or surgery
locoregional anaesthesia allowing analgesia of the hemi-thorax by ultrasound guided single injection of naropeine 5mg/ml
Paravertebral anesthesia techniqueProcedure or surgery
Ultrasound guided single injection of of naropeine 5mg/ml dose into the paravertebral space next to the thoracic spine
| Study group | Role | What they receive |
|---|---|---|
| Serratus Block | Experimental | Not described Receives: Procedure: Serratus anesthesia technique |
| Paravertebral Block | Other | Not described Receives: Procedure: Paravertebral anesthesia technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluation
Assess the non-inferiority of the single-injection echo-guided serratus block, performed in video-thoracic surgery preoperative, on the post-operative mean pain during the first 48 hours, compared to the single-injection echo-guided paravertebral block with a simple numeric scale (from 0 to 10)
Measured: 48 hours after the surgery
Secondary outcomes (4)
Walking test
Improvement of walking distance during the test at 6 min post-operative
Measured: 24 hours after the surgery
Post operative morphine dose Post operative administrated morphin dose
Mesure of intraoperative morphine administrated dose and total morphine administrated dose (in mg).
Measured: 48 hours after the surgery
Morphine side effect quantification
Collection of adverse reactions due to morphine administration (nausea, vomiting, pruritus, urine retention, respiratory depression)
Measured: 48 hours after the surgery
Length of hospitalisation duration
Number of hospitalisation days
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start5 Dec 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, comparative, monocentric, randomized non-inferiority interventional study, in double-blind.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983836
- Sponsor's protocol ID
- 19-AOI-04
- Acronym
- BSBP
- Status last verified
- Jun 2023
- First submitted
- 19 Jul 2021
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data sharing in planned
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficiency Between Serratus Block and Paravertebral Block in Video-assisted Thoracic Surgery. Double-blind Randomized Comparative Non-inferiority Study
- ClinicalTrials.gov ID
- NCT04983836
- Acronym / sponsor ID
- BSBP / 19-AOI-04
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 5 Dec 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 30 Jul 2021 (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.
Currently, the 2 main techniques of regional loco anesthesia in perioperative analgesic management of the thoracotomy remains the establishment of a thoracic epidural or paravertebral block. On the other hand, there is no standard of perioperative analgesic management in the case of thoracic surgery under video-thoracoscopy. The video-thoracoscopy, by its mini-invasive character, makes the levels of pain lower in post-operative questioning the benefit/risk balance of the paravertebral block. In 2013, Blanco published a new technique of locoregional anesthesia called the block Serratus allowing analgesia of a homolateral thorax hemi The latter by its simplicity of realization and its lesser risk is growing in thoracic surgery. This pilot study finds an equivalence in total oxycodone consumption in the first 2 post-operative days with a number of complications related to the serratus block lower than the serratus block compared to the paravertebral block in preoperative surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, comparative, monocentric, randomized non-inferiority interventional study, in double-blind.
| Arm | Type | Receives |
|---|---|---|
| Serratus Block | Experimental | Procedure: Serratus anesthesia technique |
| Paravertebral Block | Other | Procedure: Paravertebral anesthesia technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Patient who has given their free, informed and signed consent
- Social security affiliation;
Key exclusion criteria (14 listed)
- pregnant woman
- guardianship / curatorship / private patient under public law
- surgery to be performed urgently (less than 24 hours)
- surgery redux
- thoracotomy surgery
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 anesthesia techniquelocoregional anaesthesia allowing analgesia of the hemi-thorax by ultrasound guided single injection of naropeine 5mg/ml | Procedure or surgery | Serratus Block |
| Paravertebral anesthesia techniqueUltrasound guided single injection of of naropeine 5mg/ml dose into the paravertebral space next to the thoracic spine | Procedure or surgery | Paravertebral Block |
Primary outcome
Pain evaluation
Time frame: 48 hours after the surgery
Assess the non-inferiority of the single-injection echo-guided serratus block, performed in video-thoracic surgery preoperative, on the post-operative mean pain during the first 48 hours, compared to the single-injection echo-guided paravertebral block with a simple numeric scale (from 0 to 10)
4 secondary outcomes
Walking test
Time frame: 24 hours after the surgery
Post operative morphine dose Post operative administrated morphin dose
Time frame: 48 hours after the surgery
Morphine side effect quantification
Time frame: 48 hours after the surgery
Length of hospitalisation duration
Time frame: 1 year
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 9 Jun 2023.
- Individual participant dataSharing planned: No. No data sharing in planned
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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?
A study testing Serratus anesthesia technique and Paravertebral anesthesia technique in people with Anesthesia, run by Centre Hospitalier Universitaire de Nice 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 14 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 9 Jun 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 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?
Pain evaluation (time frame: 48 hours after the surgery). 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 9 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.