Idiopathic ScoliosisSAPOSNCT06194279
Analysis of Different Postoperative Analgesia Strategies Following Scoliosis Surgery
An observational study of Idiopathic Scoliosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Idiopathic scoliosis surgery is a major surgery, causing significant post-operative pain which can have a significant impact, both for the patient and for society. Different analgesic strategies have emerged in recent years, within the framework of multimodal analgesia including systemic analgesics, but also axial or… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Idiopathic Scoliosis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2023to Jun 2024
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patient aged > 15 years who underwent scoliosis surgery by the spine surgery team at Hautepierre hospital between January 1, 2020 and June 30, 2023
Who may be able to join
- Patient aged > 15 years
- Patient who underwent scoliosis surgery by the spine surgery team at Hautepierre hospital between January 1, 2020 and June 30, 2023
- Patient or holder of parental authority not opposing the reuse of their data for scientific research purposes
Who cannot join
- Oral or written refusal of the patient (or the holder of parental authority) to reuse their data for scientific research purposes
- History of spinal surgery
- Level 3 analgesics at home
- Protection of justice, titular or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Anesthésie Réanimation Médecine Péri Opératoire - CHU de Strasbourg - France
Strasbourg, 67091
Fanny PLANQUART, MD, 33 3 88 12 70 75, fanny.planquart@chru-strasbourg.fr
Fanny PLANQUART, MD
About this study
Official title: Analysis of Different Postoperative Analgesia Strategies Following Scoliosis Surgery: Retrospective Study
Idiopathic scoliosis surgery is a major surgery, causing significant post-operative pain which can have a significant impact, both for the patient and for society. Different analgesic strategies have emerged in recent years, within the framework of multimodal analgesia including systemic analgesics, but also axial or peripheral loco-regional anesthesia (LRA). These techniques are integrated into the recommendations of learned societies, aimed at optimizing the post-operative rehabilitation of patients.
If intrathecal morphine injection (ITM) and spinal erector block (ESPB) have already shown their effectiveness in reducing postoperative pain, the combination of these techniques can have a real benefit in major spinal surgery. , and has not yet been studied.
- Conditions
- Idiopathic Scoliosis
- Keywords
- Idiopathic Scoliosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine dose administered 24 hours post-operative
The aim of this retrospective study is to compare the different analgesic strategies postoperatively after scoliosis surgery
Measured: 24 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start19 Jun 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194279
- Sponsor's protocol ID
- 8961
- Acronym
- SAPOS
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Different Postoperative Analgesia Strategies Following Scoliosis Surgery: Retrospective Study
- ClinicalTrials.gov ID
- NCT06194279
- Acronym / sponsor ID
- SAPOS / 8961
- Conditions
- Idiopathic Scoliosis
- Keywords
- Idiopathic Scoliosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 8 Jan 2024 (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.
Idiopathic scoliosis surgery is a major surgery, causing significant post-operative pain which can have a significant impact, both for the patient and for society. Different analgesic strategies have emerged in recent years, within the framework of multimodal analgesia including systemic analgesics, but also axial or peripheral loco-regional anesthesia (LRA). These techniques are integrated into the recommendations of learned societies, aimed at optimizing the post-operative rehabilitation of patients.
If intrathecal morphine injection (ITM) and spinal erector block (ESPB) have already shown their effectiveness in reducing postoperative pain, the combination of these techniques can have a real benefit in major spinal surgery. , and has not yet been studied.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patient aged > 15 years who underwent scoliosis surgery by the spine surgery team at Hautepierre hospital between January 1, 2020 and June 30, 2023
Key inclusion criteria (3 listed)
- Patient aged > 15 years
- Patient who underwent scoliosis surgery by the spine surgery team at Hautepierre hospital between January 1, 2020 and June 30, 2023
- Patient or holder of parental authority not opposing the reuse of their data for scientific research purposes
Key exclusion criteria (4 listed)
- Oral or written refusal of the patient (or the holder of parental authority) to reuse their data for scientific research purposes
- History of spinal surgery
- Level 3 analgesics at home
- Protection of justice, titular or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Morphine dose administered 24 hours post-operative
Time frame: 24 hours post-operative
The aim of this retrospective study is to compare the different analgesic strategies postoperatively after scoliosis surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
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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.
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 Idiopathic Scoliosis, run by University Hospital, Strasbourg, France 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: status not confirmed, as of the sponsor's last update on 8 Jan 2024. 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 Fanny PLANQUART, MD (33 3 88 12 70 75, fanny.planquart@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine dose administered 24 hours post-operative (time frame: 24 hours post-operative). 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 8 Jan 2024.