AnalgesiaNCT04038229
Multidisciplinary Perioperative Care Pathway in Adolescents Undergoing Posterior Spinal Fusion Surgery
A study testing Enhanced recovery pathway in people with Analgesia and Scoliosis Idiopathic, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Posterior Spinal fusion (PSF) is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by extensive tissue trauma, and severe postoperative pain. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Analgesia, Scoliosis Idiopathic, Surgery
- What is being tested?
- Enhanced recovery pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Dec 2019to 1 Jan 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 Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- approved written informed consent by parent or legal representative
- idiopathic adolescent scoliosis
- planned for elective surgery: posterior spinal fusion
Who cannot join
- other types of scoliosis
- chronic opioid usage (more than 3 months)
- known unstable psychiatric medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biopsychosocial Model for a Multidisciplinary Perioperative Care Pathway in Patients Undergoing Posterior Spinal Fusion Surgery for Adolescent Idiopathic Scoliosis
Posterior Spinal fusion (PSF) is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by extensive tissue trauma, and severe postoperative pain. In addition to pain, the postoperative period is complicated by the side effects of opioids such as nausea and vomiting, itching and sedation. Various studies have shown that pain in the direct postoperative phase is an important determinant for development of chronic post-surgical pain.
The consequences of untreated acute pain are known and can also contribute to chronification in pain.
Read the detailed description
Surgical correction of adolescent idiopathic scoliosis (AIS) is indicated for severe deformity. Posterior Spinal fusion (PSF) for AIS is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by a large surgical incision, extensive tissue trauma, risk of blood loss, longer operating times and severe postoperative pain. In addition to pain, the postoperative period is complicated by the side effects of opioids such as nausea and vomiting, itching and sedation. All of this can, along with under-treatment of postoperative pain, be an important delaying factor in postoperative recovery and rehabilitation with a late hospital discharge and increased patient dissatisfaction. Various studies have shown that pain in the direct postoperative phase is an important determinant for development of chronic post-surgical pain.
The consequences of untreated pain are known and can also contribute to chronification in pain.
The incidence of chronic post-surgical pain after scoliosis fusion is 22% at 6 months and 11-15% at 1 to 5 years postoperatively. It is therefore important to minimize the pain during the first postoperative days. Untreated pain in patients is far from benign with significant negative short and long term consequences with accompanying reduction in rehabilitation duration, sleep quality of life. To date, there is no scientific evidence that some analgesic policy is superior, making adequate and safe pain relief and associated anti-emetic therapy after PSF a challenge makes for all healthcare providers involved.
- Conditions
- Analgesia, Scoliosis Idiopathic, Surgery, Postoperative Pain
- Being tested
- Enhanced recovery pathway
- Keywords
- enhanced recovery pathway, analgesia, tele-monitoring, biopsychosocial evaluation
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery pathwayOther
The applied protocol include psychological screening for yellow flags, preoperative gabapentin, peroperative multimodal preemptive management and postoperative holistic evaluation short -and long term
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Prospective derived data from children and adolescents undergoing spinal fusion due to idiopathic scoliosis |
| Enhanced recovery pathway | Experimental | Children and adolescents undergoing spinal fusion due to idiopathic scoliosis using the pre -per and postoperative enhanced recovery protocol Receives: Other: Enhanced recovery pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Evaluation of pain at rest and during mobilization using 11 point numeric rating scale daily during hospital admission and is continued after discharge up to 3 months postoperatively
Measured: From admission postoperative anesthesia care unit (PACU) up to 3 months postoperatively
Secondary outcomes (4)
evaluation of opioid-related side effect
Evaluation of opioid-related side effect as nausea, vomiting and pruritus
Measured: From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery
sleep
Subjective sleep score using 11 point numeric rating scale
Measured: From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery
daily activity
Subjective activity score using 11 point numeric rating scale
Measured: From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery
mobility
Daily mobility assessment by attending physiotherapist on 4 point scale
Measured: From day of surgery until hospital discharge (approximately 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start9 Dec 2019
- Primary completion3 Nov 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davina Wildemeersch, University Hospital, Antwerp
- Investigators
- Guy Hans, MD, PhD, Study chair, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038229
- Sponsor's protocol ID
- EC19/14/183
- Status last verified
- May 2023
- First submitted
- 26 Jul 2019
- Last updated
- 15 May 2023
- 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 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biopsychosocial Model for a Multidisciplinary Perioperative Care Pathway in Patients Undergoing Posterior Spinal Fusion Surgery for Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT04038229
- Acronym / sponsor ID
- EC19/14/183
- Conditions
- Analgesia, Scoliosis Idiopathic, Surgery, Postoperative Pain
- Keywords
- enhanced recovery pathway, analgesia, tele-monitoring, biopsychosocial evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 30 Jul 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.
Posterior Spinal fusion (PSF) is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by extensive tissue trauma, and severe postoperative pain. In addition to pain, the postoperative period is complicated by the side effects of opioids such as nausea and vomiting, itching and sedation. Various studies have shown that pain in the direct postoperative phase is an important determinant for development of chronic post-surgical pain.
The consequences of untreated acute pain are known and can also contribute to chronification in pain.
Detailed description
Surgical correction of adolescent idiopathic scoliosis (AIS) is indicated for severe deformity. Posterior Spinal fusion (PSF) for AIS is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by a large surgical incision, extensive tissue trauma, risk of blood loss, longer operating times and severe postoperative pain. In addition to pain, the postoperative period is complicated by the side effects of opioids such as nausea and vomiting, itching and sedation. All of this can, along with under-treatment of postoperative pain, be an important delaying factor in postoperative recovery and rehabilitation with a late hospital discharge and increased patient dissatisfaction. Various studies have shown that pain in the direct postoperative phase is an important determinant for development of chronic post-surgical pain.
The consequences of untreated pain are known and can also contribute to chronification in pain.
The incidence of chronic post-surgical pain after scoliosis fusion is 22% at 6 months and 11-15% at 1 to 5 years postoperatively. It is therefore important to minimize the pain during the first postoperative days. Untreated pain in patients is far from benign with significant negative short and long term consequences with accompanying reduction in rehabilitation duration, sleep quality of life. To date, there is no scientific evidence that some analgesic policy is superior, making adequate and safe pain relief and associated anti-emetic therapy after PSF a challenge makes for all healthcare providers involved.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Prospective derived data from children and adolescents undergoing spinal fusion due to idiopathic scoliosis |
| Enhanced recovery pathway | Experimental | Other: Enhanced recovery pathwayChildren and adolescents undergoing spinal fusion due to idiopathic scoliosis using the pre -per and postoperative enhanced recovery protocol |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- approved written informed consent by parent or legal representative
- idiopathic adolescent scoliosis
- planned for elective surgery: posterior spinal fusion
Key exclusion criteria (3 listed)
- other types of scoliosis
- chronic opioid usage (more than 3 months)
- known unstable psychiatric medical condition
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 |
|---|---|---|
| Enhanced recovery pathwayThe applied protocol include psychological screening for yellow flags, preoperative gabapentin, peroperative multimodal preemptive management and postoperative holistic evaluation short -and long term | Other | Enhanced recovery pathway |
Primary outcome
postoperative pain
Time frame: From admission postoperative anesthesia care unit (PACU) up to 3 months postoperatively
Evaluation of pain at rest and during mobilization using 11 point numeric rating scale daily during hospital admission and is continued after discharge up to 3 months postoperatively
4 secondary outcomes
evaluation of opioid-related side effect
Time frame: From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery
sleep
Time frame: From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery
daily activity
Time frame: From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery
mobility
Time frame: From day of surgery until hospital discharge (approximately 7 days)
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 15 May 2023.
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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.
Guy Hans, MD, PhD study chair
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced recovery pathway in people with Analgesia and Scoliosis Idiopathic, run by University Hospital, Antwerp at 1 site in Belgium.
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 3 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 15 May 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 Belgium. 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?
postoperative pain (time frame: From admission postoperative anesthesia care unit (PACU) up to 3 months postoperatively). 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 15 May 2023.