Persistent Postoperative PainPhase 3AWA3PASICNCT06271174
Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children
A Phase 3 study testing Carbocaine and Profofol and/or Suxaméthonium and/or Sévoflurane in people with Persistent Postoperative Pain, run by Nantes University Hospital at 1 site in France.
Trial summary
Persistent postoperative pain is a substantial pain (scores 4-10 using a 0-10 numeric scale) that develops 3 months after surgery. Persistent postoperative pain can be a problem even in ambulatory surgery. Read more about this study
- Who is it for?
- Ages 5 years to 183 months
- Conditions the study is for
- Persistent Postoperative Pain
- What is being tested?
- Carbocaine and Profofol and/or Suxaméthonium and/or Sévoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2024to Jun 2026
- Phase
- Phase 3
- 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 5 years to 183 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 5 years old and 15 years and 3 months
- Traumatologic orthopedic surgery in CHU Nantes
- Conscious patient (Glasgow score =15)
- Patients able to give a verbal assessment of their pain
- No contraindication to Locoregional Analgesia
- Patient member of the social security system
- Oral consent of the patient
- Signed consent of one of the two holders of parental authority
Who cannot join
- Refusal to participate of the patient or one of the two holders of parental authority
- Neurologic deficit of the operated limb before intervention
- Ischemia of the operated limb before intervention
- Polytraumatized patient
- Allergia to Carbocaïne
- Atrioventricular conduction disorders
Show all 10Show fewer
- Patient included in an other study about analgesia
- Anticoagulant treatment
- Uncontrolled epilepsy despite treatment
- Porphyria
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Nantes
Nantes
Rémi Bernardon, 02.53.48.22.15, remi.bernardon@chu-nantes.fr
Rémi Bernardon
About this study
Official title: Impact Evaluation of Perioperative Locoregional Analgesia on Persistent Postoperative Pain in Children After Orthopedic Surgery for Traumatology : a Prospective, Single Center, Randomised Controlled Study.
Persistent postoperative pain is a substantial pain (scores 4-10 using a 0-10 numeric scale) that develops 3 months after surgery.
Persistent postoperative pain can be a problem even in ambulatory surgery. Loco-regional analgesia could prevent the occurrence of this pathology but contradictory results are found in ancient studies.
Read more
This study is the first randomized controlled study in children about loco-regional analgesia and persistent postoperative pain in traumatologic orthopedic surgery.
One interventional arm will receive a locoregional analgesia after general anesthesia and before incision. The other arm will only receive systemic analgesia during general anesthesia.
The incidence of persistent postoperative pain at 3, 6 and 12 months will be compared in these two groups.
The goal is to show the decrease of the incidence of the persistent postoperative pain in the group "locoregional analgesia".
Read the detailed description
Patients between 5 years old and 15 years, 3 months old operated for a traumatologic orthopedic surgery in CHU Nantes will be included in this study.
Patients between 5 years old and 15 years, 3 months old operated for a traumatologic orthopedic surgery in CHU Nantes will be included in this study.
They will be randomized in two groups. General anesthesia will be administered in both groups.
One arm will receive a locoregional analgesia guiding by echography before incision with a local anesthetic (Carbocaïne) and a systemic analgesia if necessary. One arm will only receive a systemic analgesia.
The drugs used for general anesthesia and systemic analgesia will be standardized in the two groups.
The incidence of persistent postoperative pain at 3, 6 and 12 months will be compared in both arms. A screening of a neuropathic pain will be realized if a pain exists.
The consumption of opioids the first 24 postoperative hours, the time spent in the post interventional care unit and the incidence of nausea, vomiting will also be compared.
The goal is to show the decrease of the incidence of the persistent postoperative pain and a better recovery in the post interventional care unit in the group "locoregional analgesia".
- Conditions
- Persistent Postoperative Pain
- Being tested
- Carbocaine, Profofol and/or Suxaméthonium and/or Sévoflurane
- Keywords
- Persistent Postoperative Pain, Post-surgical chronic pain, Children, Loco-regional Analgesia, Orthopedic surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbocaineDrug
Also called Loco regional Analgesia
After general anesthesia and before incision, patients will receive loco-regional analgesia.
Carbocaïne will be injected around the nerve responsible of the innervation of the operated area by echography guidance.
Profofol and/or Suxaméthonium and/or SévofluraneDrug
Also called General anesthetic
General anesthesia
Anesthetic induction is performed on a full stomach using :
- Intravenous hypnotic Propofol 2-5 mg/kg
- A rapid-acting intravenous curare Suxamethonium 1 mg/kg
On an empty stomach :
- An intravenous hypnotic Propofol 2 to 5 mg/kg or/and an inhalatory hypnotic, Sevoflurane, as anesthetic co-induction by these 2 agents is generally used in pediatrics.
| Study group | Role | What they receive |
|---|---|---|
| Loco-Regional Analgesia | Experimental | Patients will receive Loco-Regional Analgesia during General Anesthesia, and systemic analgesia if necessary
* Carbocaine Receives: Drug: Carbocaine; Drug: Profofol and/or Suxaméthonium and/or Sévoflurane |
| Systemic Analgesia Only | Active comparator | Patients will just receive General Anesthesia and systemic analgesia.
_ Profofol and/or Suxaméthonium and/or Sévoflurane Receives: Drug: Profofol and/or Suxaméthonium and/or Sévoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent Postoperative Pain
Numerical Scale of pain superior to 3 (0 to 10). 0 : no pain - better outcome 10 : max of pain - worse outcome
Measured: 3 months after surgery
Secondary outcomes (12)
Screening of neuropathic pain if persistent postoperative pain - 3 months
DN4 score (0 to 10) - Self-assessment scale for estimating the probability of neuropathic pain Patient score is equal to or greater than 4/10, the test is positive 0 : minimum value / better outcome 10 : maximul value / worse outcome
Measured: 3 months after surgery.
Screening of neuropathic pain if persistent postoperative pain - 6 months
DN4 score (0 to 10) - Self-assessment scale for estimating the probability of neuropathic pain Patient score is equal to or greater than 4/10, the test is positive 0 : minimum value / better outcome 10 : maximul value / worse outcome
Measured: 6 months after surgery.
Screening of neuropathic pain if persistent postoperative pain - 12 months
DN4 score (0 to ten) - Self-assessment scale for estimating the probability of neuropathic pain Patient score is equal to or greater than 4/10, the test is positive 0 : minimum value / better outcome 10 : maximul value / worse outcome
Measured: 12 months after surgery.
1st EN score in immediate post-operative ICU before morphine titration
Numerical Scale of pain (0 to 10) 0 : no pain - better outcome 10 : max of pain - worse outcome
Measured: in Post Interventional Care Unit after the surgery
Persistent postoperative pain at 6 months.
Numerical Scale of pain (0 to 10) 0 : no pain - better outcome 10 : max of pain - worse outcome
Measured: 6 months after surgery.
Persistent postoperative pain at 12 months.
Numerical Scale of pain (0 to 10) 0 : no pain - better outcome 10 : max of pain - worse outcome
Measured: 12 months after surgery.
Postoperative nausea and vomiting
presence or absence
Measured: In Post Interventional Care Unit - after the surgery-
Time in Post Interventional Care Unit
Evaluation in minutes.
Measured: In Post Interventional Care Unit - after the surgery -
Opioïd dose received - Per-operative
Evaluation in milligrammes
Measured: Per-operative
Opioïd dose received - in Post Interventional Care Unit
Evaluation in milligrammes
Measured: in Post Interventional Care Unit after the surgery-
Opioïd dose received
Evaluation in milligrammes
Measured: during the first post-operative 24 hours in the surgery department
Intravenous Morphine dose received in Post Interventional Care Unit
Evaluation in milligrammes
Measured: in Post Interventional Care Unit after the surgery-
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start6 Jun 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Postoperative PainStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271174
- Sponsor's protocol ID
- RC23_0009
- Acronym
- AWA3PASIC
- Status last verified
- Jun 2024
- First submitted
- 19 Jul 2023
- Last updated
- 12 Jun 2024
- 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 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of Perioperative Locoregional Analgesia on Persistent Postoperative Pain in Children After Orthopedic Surgery for Traumatology : a Prospective, Single Center, Randomised Controlled Study.
- ClinicalTrials.gov ID
- NCT06271174
- Acronym / sponsor ID
- AWA3PASIC / RC23_0009
- Conditions
- Persistent Postoperative Pain
- Keywords
- Persistent Postoperative Pain, Post-surgical chronic pain, Children, Loco-regional Analgesia, Orthopedic surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Fondation Apicil
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Feb 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.
Persistent postoperative pain is a substantial pain (scores 4-10 using a 0-10 numeric scale) that develops 3 months after surgery.
Persistent postoperative pain can be a problem even in ambulatory surgery. Loco-regional analgesia could prevent the occurrence of this pathology but contradictory results are found in ancient studies.
This study is the first randomized controlled study in children about loco-regional analgesia and persistent postoperative pain in traumatologic orthopedic surgery.
One interventional arm will receive a locoregional analgesia after general anesthesia and before incision. The other arm will only receive systemic analgesia during general anesthesia.
The incidence of persistent postoperative pain at 3, 6 and 12 months will be compared in these two groups.
The goal is to show the decrease of the incidence of the persistent postoperative pain in the group "locoregional analgesia".
Detailed description
Patients between 5 years old and 15 years, 3 months old operated for a traumatologic orthopedic surgery in CHU Nantes will be included in this study.
Patients between 5 years old and 15 years, 3 months old operated for a traumatologic orthopedic surgery in CHU Nantes will be included in this study.
They will be randomized in two groups. General anesthesia will be administered in both groups.
One arm will receive a locoregional analgesia guiding by echography before incision with a local anesthetic (Carbocaïne) and a systemic analgesia if necessary. One arm will only receive a systemic analgesia.
The drugs used for general anesthesia and systemic analgesia will be standardized in the two groups.
The incidence of persistent postoperative pain at 3, 6 and 12 months will be compared in both arms. A screening of a neuropathic pain will be realized if a pain exists.
The consumption of opioids the first 24 postoperative hours, the time spent in the post interventional care unit and the incidence of nausea, vomiting will also be compared.
The goal is to show the decrease of the incidence of the persistent postoperative pain and a better recovery in the post interventional care unit in the group "locoregional analgesia".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loco-Regional Analgesia | Experimental | Drug: Carbocaine, Drug: Profofol and/or Suxaméthonium and/or SévofluranePatients will receive Loco-Regional Analgesia during General Anesthesia, and systemic analgesia if necessary * Carbocaine |
| Systemic Analgesia Only | Active comparator | Drug: Profofol and/or Suxaméthonium and/or SévofluranePatients will just receive General Anesthesia and systemic analgesia. _ Profofol and/or Suxaméthonium and/or Sévoflurane |
Who may qualify
- Ages
- 5 years to 183 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age between 5 years old and 15 years and 3 months
- Traumatologic orthopedic surgery in CHU Nantes
- Conscious patient (Glasgow score =15)
- Patients able to give a verbal assessment of their pain
- No contraindication to Locoregional Analgesia
Key exclusion criteria (10 listed)
- Refusal to participate of the patient or one of the two holders of parental authority
- Neurologic deficit of the operated limb before intervention
- Ischemia of the operated limb before intervention
- Polytraumatized patient
- Allergia to Carbocaïne
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 |
|---|---|---|
| CarbocaineAlso: Loco regional AnalgesiaAfter general anesthesia and before incision, patients will receive loco-regional analgesia. Carbocaïne will be injected around the nerve responsible of the innervation of the operated area by echography guidance. | Drug | Loco-Regional Analgesia |
| Profofol and/or Suxaméthonium and/or SévofluraneAlso: General anestheticGeneral anesthesia Anesthetic induction is performed on a full stomach using : * Intravenous hypnotic Propofol 2-5 mg/kg * A rapid-acting intravenous curare Suxamethonium 1 mg/kg On an empty stomach : - An intravenous hypnotic Propofol 2 to 5 mg/kg or/and an inhalatory hypnotic, Sevoflurane, as anesthetic co-induction by these 2 agents is generally used in pediatrics. | Drug | Loco-Regional Analgesia, Systemic Analgesia Only |
Primary outcome
Persistent Postoperative Pain
Time frame: 3 months after surgery
Numerical Scale of pain superior to 3 (0 to 10). 0 : no pain - better outcome 10 : max of pain - worse outcome
12 secondary outcomes
Screening of neuropathic pain if persistent postoperative pain - 3 months
Time frame: 3 months after surgery.
Screening of neuropathic pain if persistent postoperative pain - 6 months
Time frame: 6 months after surgery.
Screening of neuropathic pain if persistent postoperative pain - 12 months
Time frame: 12 months after surgery.
1st EN score in immediate post-operative ICU before morphine titration
Time frame: in Post Interventional Care Unit after the surgery
Persistent postoperative pain at 6 months.
Time frame: 6 months after surgery.
Persistent postoperative pain at 12 months.
Time frame: 12 months after surgery.
Postoperative nausea and vomiting
Time frame: In Post Interventional Care Unit - after the surgery-
Time in Post Interventional Care Unit
Time frame: In Post Interventional Care Unit - after the surgery -
Opioïd dose received - Per-operative
Time frame: Per-operative
Opioïd dose received - in Post Interventional Care Unit
Time frame: in Post Interventional Care Unit after the surgery-
Opioïd dose received
Time frame: during the first post-operative 24 hours in the surgery department
Intravenous Morphine dose received in Post Interventional Care Unit
Time frame: in Post Interventional Care Unit after the surgery-
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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?
A Phase 3 study testing Carbocaine and Profofol and/or Suxaméthonium and/or Sévoflurane in people with Persistent Postoperative 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 8 inclusion and 10 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 12 Jun 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rémi Bernardon (+33(0)2 43 48 22 15, remi.bernardon@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent Postoperative Pain (time frame: 3 months 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 12 Jun 2024.