Pulmonary SurgerySPIRITNCT04147754
Erector Spinae Block, Epidural Analgesia and Intrathecal Analgesia in Thoracic Surgery
An observational study of Pulmonary Surgery, run by University Hospital, Angers at 1 site in France.
Trial summary
Pulmonary thoracic surgery is often responsible for severe postoperative pain, which is associated with an increase in postoperative morbidity and mortality. Moreover, postoperative thoracic pain has a strong impact on patient rehabilitation and is associated with an increase in hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Surgery
- What is being tested?
- Epidural anesthesia, Intrathecal morphine and Erector spinae block
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2019to Feb 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
- Adult, Older adult
Study population: Patients undergoing thoracic surgery for pulmonary resection in the University Hospital of Angers, in France.
Who may be able to join
- Thoracic surgery for pulmonary resection
- Scheduled regional anesthesia: epidural anesthesia, intrathecal morphine or erector spinae block
Who cannot join
- No epidural anesthesia or no intrathecal morphine or no erector spinae block performed
Trial locations and contacts
1 site in 1 country.
Laurent Beydon, MD PHD contact
France1 site
CHU Angers - DEPARTEMENT D'ANESTHESIE REANIMATION
Angers, 49100
Emmanuel Rineau, MD
Laurent Beydon, MD PhD
About this study
Official title: Efficacités comparées du Bloc Des Muscles érecteurs du Rachis, du Bloc péridural et de la rachianalgésie en Chirurgie Thoracique Majeure.
Pulmonary thoracic surgery is often responsible for severe postoperative pain, which is associated with an increase in postoperative morbidity and mortality. Moreover, postoperative thoracic pain has a strong impact on patient rehabilitation and is associated with an increase in hospital stay.
Various analgesic techniques allow effective management of pain in the context of thoracic surgery. Regional anesthesia, particularly, allows a powerful analgesia, and limits the use of opioids and their side effects. Among regional anesthesia techniques, thoracic epidural analgesia has become the gold standard for post-thoracotomy analgesia. However, it induces a sympathetic block that promotes in particular per and postoperative hypotension and acute urinary retentions. Thus, new regional anesthesia techniques have been developed and assessed in thoracic surgery in order to avoid side effects related to epidural analgesia, particularly paravertebral block and erector spinae block, but also intrathecal analgesia. Paravertebral block has shown analgesic efficacy after thoracic surgery, and its interest in reducing the risk of hypotension, acute urinary retention, pruritus and postoperative nausea and vomiting compared with the epidural analgesia. Erector spinae block, recently described and evaluated in this context of thoracic surgery, seems to have the same interests and to be easier to achieve than the paravertebral block, but has been little studied. Finally, intrathecal morphine is frequently used because of an easy and rapid realization, and because it allows an adequate analgesia and the reduction of the duration of stay in intensive care compared to the epidural one. However, despite its frequent use, very few studies have compared intrathecal anesthesia with the epidural and other peri-spinal blocks.
These three types of analgesia, epidural analgesia, intrathecal morphine, and erector spinae block are regional anesthesia methods regularly used for pulmonary surgery in the department of the investigators. All of these techniques have shown their analgesic efficacy, but each seems to have particular respective interests, in terms of achievement, management, or perioperative rehabilitation. The objective of the investigators study is to evaluate the effectiveness of each of its techniques to treat postoperative pain and improve the rehabilitation of these patients.
- Conditions
- Pulmonary Surgery
- Being tested
- Epidural anesthesia, Intrathecal morphine, Erector spinae block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural anesthesiaProcedure or surgery
Preoperative epidural anesthesia at physician discretion
Intrathecal morphineProcedure or surgery
Preoperative intrathecal morphine at physician discretion
Erector spinae blockProcedure or surgery
Preoperative erector spinae block at physician discretion
| Study group | Role | What they receive |
|---|---|---|
| Epidural anesthesia | At physician discretion (observational study) Receives: Procedure: Epidural anesthesia | |
| Intrathecal morphine | At physician discretion (observational study) Receives: Procedure: Intrathecal morphine | |
| Erector spinae block | At physician discretion (observational study) 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 (6)
Total consumption of morphine (per and postoperative)
Measured: Hour 2, Day 1, Day 2 and Day 3 after surgery.
Length of stay in intensive care unit
Measured: Through study completion, an average of 1 year
Length of hospital stay
Measured: Through study completion, an average of 1 year
Impact on respiratory function
Peak Flow in L/min
Measured: 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.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start4 Nov 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 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
- NCT04147754
- Sponsor's protocol ID
- 2019/97
- Acronym
- SPIRIT
- Status last verified
- Oct 2019
- First submitted
- 24 Oct 2019
- Last updated
- 1 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 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacités comparées du Bloc Des Muscles érecteurs du Rachis, du Bloc péridural et de la rachianalgésie en Chirurgie Thoracique Majeure.
- ClinicalTrials.gov ID
- NCT04147754
- Acronym / sponsor ID
- SPIRIT / 2019/97
- Conditions
- Pulmonary Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 4 Nov 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 1 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.
Pulmonary thoracic surgery is often responsible for severe postoperative pain, which is associated with an increase in postoperative morbidity and mortality. Moreover, postoperative thoracic pain has a strong impact on patient rehabilitation and is associated with an increase in hospital stay.
Various analgesic techniques allow effective management of pain in the context of thoracic surgery. Regional anesthesia, particularly, allows a powerful analgesia, and limits the use of opioids and their side effects. Among regional anesthesia techniques, thoracic epidural analgesia has become the gold standard for post-thoracotomy analgesia. However, it induces a sympathetic block that promotes in particular per and postoperative hypotension and acute urinary retentions. Thus, new regional anesthesia techniques have been developed and assessed in thoracic surgery in order to avoid side effects related to epidural analgesia, particularly paravertebral block and erector spinae block, but also intrathecal analgesia. Paravertebral block has shown analgesic efficacy after thoracic surgery, and its interest in reducing the risk of hypotension, acute urinary retention, pruritus and postoperative nausea and vomiting compared with the epidural analgesia. Erector spinae block, recently described and evaluated in this context of thoracic surgery, seems to have the same interests and to be easier to achieve than the paravertebral block, but has been little studied. Finally, intrathecal morphine is frequently used because of an easy and rapid realization, and because it allows an adequate analgesia and the reduction of the duration of stay in intensive care compared to the epidural one. However, despite its frequent use, very few studies have compared intrathecal anesthesia with the epidural and other peri-spinal blocks.
These three types of analgesia, epidural analgesia, intrathecal morphine, and erector spinae block are regional anesthesia methods regularly used for pulmonary surgery in the department of the investigators. All of these techniques have shown their analgesic efficacy, but each seems to have particular respective interests, in terms of achievement, management, or perioperative rehabilitation. The objective of the investigators study is to evaluate the effectiveness of each of its techniques to treat postoperative pain and improve the rehabilitation of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epidural anesthesia | – | Procedure: Epidural anesthesiaAt physician discretion (observational study) |
| Intrathecal morphine | – | Procedure: Intrathecal morphineAt physician discretion (observational study) |
| Erector spinae block | – | Procedure: Erector spinae blockAt physician discretion (observational study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing thoracic surgery for pulmonary resection in the University Hospital of Angers, in France.
Key inclusion criteria (2 listed)
- Thoracic surgery for pulmonary resection
- Scheduled regional anesthesia: epidural anesthesia, intrathecal morphine or erector spinae block
Key exclusion criteria (1 listed)
- No epidural anesthesia or no intrathecal morphine or no erector spinae block performed
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 |
|---|---|---|
| Epidural anesthesiaPreoperative epidural anesthesia at physician discretion | Procedure or surgery | Epidural anesthesia |
| Intrathecal morphinePreoperative intrathecal morphine at physician discretion | Procedure or surgery | Intrathecal morphine |
| Erector spinae blockPreoperative erector spinae block at physician discretion | 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)
6 secondary outcomes
Total consumption of morphine (per and postoperative)
Time frame: Hour 2, Day 1, Day 2 and Day 3 after surgery.
Length of stay in intensive care unit
Time frame: Through study completion, an average of 1 year
Length of hospital stay
Time frame: Through study completion, an average of 1 year
Impact on respiratory function
Time frame: 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.
Postoperative pain assessment at other times
Time frame: Hour 2, Day 1, and Day 3 after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 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.
Laurent Beydon, MD PHD 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 Pulmonary 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 2 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: status not confirmed, as of the sponsor's last update on 1 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 1 Nov 2019.