Pain, PostoperativeNCT04183049
Improved Rehabilitation After Spinal Surgery in Adolescents
An observational study of Pain, Postoperative and Pain, run by Nantes University Hospital at 1 site in France.
Trial summary
Impact of the OFA technique on postoperative recovery from adolescent spine surgery and the incidence of chronic postoperative pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Postoperative, Pain, Scoliosis
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2019to 1 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: - As the study concerns a specifically paediatric pathology, minors will not be excluded from the study.
Who may be able to join
- Patent with idiopathic or secondary surgical scoliosis
- Management by the paediatric anaesthesia team at the Mother and Child - Hospital of the University Hospital of Nantes
- Non-opposition to inclusion in the study collected orally from the patient and parents
- Satisfying oral and written comprehension of the French language, without interpreter
- Ability to participate in a telephone interview
Who cannot join
- Patient that does not understand French correctly
- Patient unable to express himself/herself correctly in French
- Patient with a non-scoliotic surgical spinal pathology
- Refusal to participate in the study
- Absence of a record of non-opposition to participation in the study from the patient and his or her parents
- Cerebral palsy or any other condition that does not allow participation in a telephone interview without particular difficulty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improved Rehabilitation After Spinal Surgery in Adolescents: Prospective Observational Epidemiological Study of a Protocol Without Opioid
Impact of the OFA technique on postoperative recovery from adolescent spine surgery and the incidence of chronic postoperative pain.
Read the detailed description
RACAROFA is an observational, prospective study based on the hypothesis that the OFA technique effectively improves the long-term postoperative rehabilitation of adolescents and reduces the incidence of CPSP. A prospective French multicentre study on this topic is currently not feasible, as other multicentre studies (pain monitoring by the ANI, blood saving strategy) would interfere with potential recruitment.
- Conditions
- Pain, Postoperative, Pain, Scoliosis, Spinal Fusion
- Keywords
- Dexmedetomidine, Analgesics, Opioid free anesthesia, Chronic postsurgical pain
- Medical subject headings
- Pain, Postoperative, Pain, Scoliosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic postsurgical pain after surgery in the adolescent cohort included in the study RACAROFA
Pain at the surgical site, rated at more than 3 on a numerical scale graduated from 0 (no pain) to 10 (maximum pain) during a telephone interview.
Measured: Three months after surgery
Incidence of chronic postsurgical pain after surgery in the adolescent cohort included in the study RACAROFA
Pain at the surgical site, rated at more than 3 on a numerical scale graduated from 0 (no pain) to 10 (maximum pain) during a telephone interview.
Measured: Sixth months after surgery
Secondary outcomes (20)
Occurence of a postoperative opioid-related adverse event
postoperative hypoxemia or PONV (postoperative nausea and vomiting) or excessive sedation. Postoperative hypoxemia is defined as an oxygen saturation (SpO2) < 95% with a need for oxygen supplementation within the first 48h after extubation.
PONV is defined by use of antiemetics of PONV within the first 48h after extubation.
Excessive sedation is defined by a score of 3 in a scale of sedation wich is S1 awake, S2 mild drowsiness, S3 non awakenable.
Measured: Within the first 48 hours after extubation
Level of preoperative quality of life
SRS-30 score (Scoliosis Research Society Health-Related Quality of Life Questionnaire), during a telephone interview. Score between 1 and 5 where 5 is the higher level of quality of live.
Measured: Three month after surgery
Postoperative opioid consumption
Cumulative consumption of opioid in mg/kg.
Measured: Within the 2 first weeks postsurgery
Level of preoperative quality of life: SRS-30 score
SRS-30 score (Scoliosis Research Society Health-Related Quality of Life Questionnaire), during a telephone interview. Score between 1 and 5 where 5 is the higher level of quality of live.
Measured: Sixth month after surgery
Postoperative rehabilitation
Number of days between surgery and first deambulation
Measured: Within the first 2 weeks postsurgery
Length of stay in the hospital
Number of days in the hospital.
Measured: Within the first 2 weeks postsurgery
Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA
State trait anxiety Inventory for Children (STAIC) score evaluated during a telephone interview. Score between 20 and 60, where 60 is the higher level of anxiety
Measured: Two weeks before surgery
Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA
State trait anxiety Inventory for Children (STAIC) score evaluated during a telephone interview. Score between 20 and 60, where 60 is the higher level of anxiety
Measured: three months after surgery
Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA
State trait anxiety Inventory for Children (STAIC) score evaluated during a telephone interview. Score between 20 and 60, where 60 is the higher level of anxiety
Measured: sixth months after surgery
Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.
Modified DN4 score superior at 4.
Measured: Three months after surgery
Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.
Modified DN4 score superior at 4.
Measured: Six months after surgery
Postoperative antalgics consumption other than opioid
Cumulative antalgics consumption other than opioid.
Measured: Within the first 2 weeks postsurgery
Incidence of preoperative pain in the adolescent cohort included in the study RACAROFA.
Back pain, rated at more than 3 on a numerical scale graduated from 0 (no pain) to 10 (maximum pain) during a telephone interview.
Measured: Two weeks before surgery
Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.
Pain castrophizing scale for adolescent, score evaluated during a telephone interview. Score between 0 and 52, where 52 is the higher level of catastrophism.
Measured: Two weeks before surgery, three and sixth months after surgery
Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.
Pain castrophizing scale for adolescent, score evaluated during a telephone interview. Score between 0 and 52, where 52 is the higher level of catastrophism.
Measured: three months after surgery
Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.
Pain castrophizing scale for adolescent, score evaluated during a telephone interview. Score between 0 and 52, where 52 is the higher level of catastrophism.
Measured: sixth months after surgery
Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.
Pain castrophizing scale for adult, score evaluated during a telephone interview. Score between 0 and 52, where 52 is the higher level of catastrophism.
Measured: Two weeks before surgery, three and sixth months after surgery
Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.
Pain castrophizing scale for adult, score evaluated during a telephone interview. Score between 0 and 52, where 52 is the higher level of catastrophism.
Measured: three months after surgery
Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.
Pain castrophizing scale for adult, score evaluated during a telephone interview. Score between 0 and 52, where 52 is the higher level of catastrophism.
Measured: sixth months after surgery
Level of preoperative quality of life.
SRS-22 score (Scoliosis Research Society Health-Related Quality of Life Questionnaire), during a telephone interview. Score between 1 and 5 where 5 is the higher level of quality of live
Measured: Two weeks before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start18 Dec 2019
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corine LEJUS, PUPH, Principal investigator, Nantes University HospitalGuy LETELLIER, PH, Principal investigator, Establishment for Children and Adolescents in the Nantes Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183049
- Sponsor's protocol ID
- RC19_0255
- Status last verified
- Aug 2021
- First submitted
- 14 Nov 2019
- Last updated
- 30 Aug 2021
- 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 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Rehabilitation After Spinal Surgery in Adolescents: Prospective Observational Epidemiological Study of a Protocol Without Opioid
- ClinicalTrials.gov ID
- NCT04183049
- Acronym / sponsor ID
- RC19_0255
- Conditions
- Pain, Postoperative, Pain, Scoliosis, Spinal Fusion
- Keywords
- Dexmedetomidine, Analgesics, Opioid free anesthesia, Chronic postsurgical pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 3 Dec 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.
Impact of the OFA technique on postoperative recovery from adolescent spine surgery and the incidence of chronic postoperative pain.
Detailed description
RACAROFA is an observational, prospective study based on the hypothesis that the OFA technique effectively improves the long-term postoperative rehabilitation of adolescents and reduces the incidence of CPSP. A prospective French multicentre study on this topic is currently not feasible, as other multicentre studies (pain monitoring by the ANI, blood saving strategy) would interfere with potential recruitment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - As the study concerns a specifically paediatric pathology, minors will not be excluded from the study.
Key inclusion criteria (5 listed)
- Patent with idiopathic or secondary surgical scoliosis
- Management by the paediatric anaesthesia team at the Mother and Child - Hospital of the University Hospital of Nantes
- Non-opposition to inclusion in the study collected orally from the patient and parents
- Satisfying oral and written comprehension of the French language, without interpreter
- Ability to participate in a telephone interview
Key exclusion criteria (6 listed)
- Patient that does not understand French correctly
- Patient unable to express himself/herself correctly in French
- Patient with a non-scoliotic surgical spinal pathology
- Refusal to participate in the study
- Absence of a record of non-opposition to participation in the study from the patient and his or her parents
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
Incidence of chronic postsurgical pain after surgery in the adolescent cohort included in the study RACAROFA
Time frame: Three months after surgery
Pain at the surgical site, rated at more than 3 on a numerical scale graduated from 0 (no pain) to 10 (maximum pain) during a telephone interview.
Incidence of chronic postsurgical pain after surgery in the adolescent cohort included in the study RACAROFA
Time frame: Sixth months after surgery
Pain at the surgical site, rated at more than 3 on a numerical scale graduated from 0 (no pain) to 10 (maximum pain) during a telephone interview.
20 secondary outcomes
Occurence of a postoperative opioid-related adverse event
Time frame: Within the first 48 hours after extubation
Level of preoperative quality of life
Time frame: Three month after surgery
Postoperative opioid consumption
Time frame: Within the 2 first weeks postsurgery
Level of preoperative quality of life: SRS-30 score
Time frame: Sixth month after surgery
Postoperative rehabilitation
Time frame: Within the first 2 weeks postsurgery
Length of stay in the hospital
Time frame: Within the first 2 weeks postsurgery
Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA
Time frame: Two weeks before surgery
Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA
Time frame: three months after surgery
Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA
Time frame: sixth months after surgery
Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.
Time frame: Three months after surgery
Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.
Time frame: Six months after surgery
Postoperative antalgics consumption other than opioid
Time frame: Within the first 2 weeks postsurgery
Incidence of preoperative pain in the adolescent cohort included in the study RACAROFA.
Time frame: Two weeks before surgery
Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.
Time frame: Two weeks before surgery, three and sixth months after surgery
Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.
Time frame: three months after surgery
Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.
Time frame: sixth months after surgery
Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.
Time frame: Two weeks before surgery, three and sixth months after surgery
Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.
Time frame: three months after surgery
Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.
Time frame: sixth months after surgery
Level of preoperative quality of life.
Time frame: Two weeks before surgery
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 30 Aug 2021.
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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.
Corine LEJUS, PUPH principal investigator
Nantes University Hospital
Guy LETELLIER, PH principal investigator
Establishment for Children and Adolescents in the Nantes Region
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 Pain, Postoperative and Pain, run by Nantes University Hospital 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 5 inclusion and 6 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 30 Aug 2021. 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?
Incidence of chronic postsurgical pain after surgery in the adolescent cohort included in the study RACAROFA (time frame: Three months after surgery). The study lists 2 primary outcomes in all. 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 30 Aug 2021.