Thoracic SurgeryMERCOTENCT04167046
Erector Spinae Block in First Rib Resection: a Monocentric Before-after Study
An observational study of Thoracic Surgery, run by University Hospital, Angers at 1 site in France.
Trial summary
First rib resection surgery for thoracic outlet syndrome is associated with an intense postoperative pain. It leads to significant consumption of nonsteroidal anti-inflammatory drugs and opioids, and hospitalization for several days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Erector spinae block
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2019to Mar 2021
- 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: Patients undergoing first rib resection for thoracic outlet syndrome
Who may be able to join
- First rib resection for thoracic outlet syndrome
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Siaudeau Hélène, MD contact
France1 site
Département d'Anesthésie-Réanimation du CHU d'Angers
Angers, 49100
Emmanuel Rineau, MD
Hélène Siaudeau, MD
About this study
Official title: Bloc Des Muscles Erecteurs du Rachis Pour Chirurgie d'exérèse de première côte Dans le Cadre du Syndrome du défilé Cervico-thoracique: évaluation Avant-après au CHU d'Angers.
First rib resection surgery for thoracic outlet syndrome is associated with an intense postoperative pain. It leads to significant consumption of nonsteroidal anti-inflammatory drugs and opioids, and hospitalization for several days.
In our center, first rib resection surgery was usually performed under general anesthesia combined with diffuse local infiltration of the axillary fossa. Erector spinae block is an interfascial block where a local anesthetic is injected between the erector spinae muscle and the transverse process, in order to obtain a multimetameric analgesia. It has now shown its efficacy and its safety in thoracic and abdominal surgeries by decreasing the morphine consumption and pain scores. Since November 2018, this erector spinae block is systematically performed preoperatively for first rib resection in our center, in association with a general anesthesia. Patient satisfaction seems important but remains to be assessed objectively.
In a before-after study, our goal is to assess the impact of the use of erector spinae block on postoperative pain in the first rib resection surgery.
- Conditions
- Thoracic Surgery
- Being tested
- Erector spinae block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae blockProcedure or surgery
Preoperative erector spinae block.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients in this group did not receive an erector spinae block. Data are obtained retrospectively (years 2017 and 2018). | |
| Erector spinae block | Patients in this group receive an erector spinae block. Data will be obtained prospectively. Receives: Procedure: Erector spinae block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment at H+48
Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain)
Measured: Day 2 after surgery
Secondary outcomes (4)
Postoperative pain assessment at other times
Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain)
Measured: Hour 2, Day 1, and Day 3 after surgery
Total consumption of morphine (per and postoperative)
Measured: Hour 2, Day 1, Day 2 and Day 3 after surgery
Frequency of adverse effects related to morphine Frequency of morphine side effects
Measured: Hour 2, Day 1, Day 2 and Day 3 after surgery
Length of hospital stay
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study startNov 2019 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Emmanuel Rineau, MD, Principal investigator, University Hospital of Angers, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167046
- Sponsor's protocol ID
- 2019/98
- Acronym
- MERCOTE
- Status last verified
- Nov 2019
- First submitted
- 14 Nov 2019
- Last updated
- 18 Nov 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 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bloc Des Muscles Erecteurs du Rachis Pour Chirurgie d'exérèse de première côte Dans le Cadre du Syndrome du défilé Cervico-thoracique: évaluation Avant-après au CHU d'Angers.
- ClinicalTrials.gov ID
- NCT04167046
- Acronym / sponsor ID
- MERCOTE / 2019/98
- Conditions
- Thoracic Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Nov 2019 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 18 Nov 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.
First rib resection surgery for thoracic outlet syndrome is associated with an intense postoperative pain. It leads to significant consumption of nonsteroidal anti-inflammatory drugs and opioids, and hospitalization for several days.
In our center, first rib resection surgery was usually performed under general anesthesia combined with diffuse local infiltration of the axillary fossa. Erector spinae block is an interfascial block where a local anesthetic is injected between the erector spinae muscle and the transverse process, in order to obtain a multimetameric analgesia. It has now shown its efficacy and its safety in thoracic and abdominal surgeries by decreasing the morphine consumption and pain scores. Since November 2018, this erector spinae block is systematically performed preoperatively for first rib resection in our center, in association with a general anesthesia. Patient satisfaction seems important but remains to be assessed objectively.
In a before-after study, our goal is to assess the impact of the use of erector spinae block on postoperative pain in the first rib resection surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Patients in this group did not receive an erector spinae block. Data are obtained retrospectively (years 2017 and 2018). |
| Erector spinae block | – | Procedure: Erector spinae blockPatients in this group receive an erector spinae block. Data will be obtained prospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing first rib resection for thoracic outlet syndrome
Key inclusion criteria (1 listed)
- First rib resection for thoracic outlet syndrome
Key exclusion criteria (0 listed)
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 blockPreoperative erector spinae block. | Procedure or surgery | Erector spinae block |
Primary outcome
Pain assessment at H+48
Time frame: Day 2 after surgery
Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain)
4 secondary outcomes
Postoperative pain assessment at other times
Time frame: Hour 2, Day 1, and Day 3 after surgery
Total consumption of morphine (per and postoperative)
Time frame: Hour 2, Day 1, Day 2 and Day 3 after surgery
Frequency of adverse effects related to morphine Frequency of morphine side effects
Time frame: Hour 2, Day 1, Day 2 and Day 3 after surgery
Length of hospital stay
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
Related trials for Thoracic Surgery
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Not yet recruiting
Impact of High Thoracic Paravertebral Block on Diaphragmatic Function: a Prospective Study
Breast Cancer Surgery, Breast Cancer Surgery Pain
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
RecruitingPhase 2
Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer
Lung Non-Small Cell Carcinoma, Stage IB Lung Cancer AJCC v8
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.
Siaudeau Hélène, MD contact
Emmanuel Rineau, MD principal investigator
University Hospital of Angers, France
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 University Hospital, Angers 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 0 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 18 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel Rineau, MD (+33241353951, erineau@live.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment at H+48 (time frame: Day 2 after 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 18 Nov 2019.