Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children
- Conditions
- Persistent Postoperative Pain
- Interventions
- Drug: Profofol and/or Suxaméthonium and/or Sévoflurane
- Registration Number
- NCT06271174
- Lead Sponsor
- Nantes University Hospital
- Brief 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. 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".
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 208
- 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
- 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
- Patient included in an other study about analgesia
- Anticoagulant treatment
- Uncontrolled epilepsy despite treatment
- Porphyria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Loco-Regional Analgesia Carbocaine Patients will receive Loco-Regional Analgesia during General Anesthesia, and systemic analgesia if necessary * Carbocaine Loco-Regional Analgesia Profofol and/or Suxaméthonium and/or Sévoflurane Patients will receive Loco-Regional Analgesia during General Anesthesia, and systemic analgesia if necessary * Carbocaine Systemic Analgesia Only Profofol and/or Suxaméthonium and/or Sévoflurane Patients will just receive General Anesthesia and systemic analgesia. _ Profofol and/or Suxaméthonium and/or Sévoflurane
- Primary Outcome Measures
Name Time Method Persistent Postoperative Pain 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
- Secondary Outcome Measures
Name Time Method Time in Post Interventional Care Unit In Post Interventional Care Unit - after the surgery - Evaluation in minutes.
Persistent postoperative pain at 12 months. 12 months after surgery. Numerical Scale of pain (0 to 10) 0 : no pain - better outcome 10 : max of pain - worse outcome
Intravenous Morphine dose received in Post Interventional Care Unit in Post Interventional Care Unit after the surgery- Evaluation in milligrammes
Opioïd dose received - in Post Interventional Care Unit in Post Interventional Care Unit after the surgery- Evaluation in milligrammes
Screening of neuropathic pain if persistent postoperative pain - 3 months 3 months after surgery. 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
Screening of neuropathic pain if persistent postoperative pain - 12 months 12 months after surgery. 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
1st EN score in immediate post-operative ICU before morphine titration in Post Interventional Care Unit after the surgery Numerical Scale of pain (0 to 10) 0 : no pain - better outcome 10 : max of pain - worse outcome
Persistent postoperative pain at 6 months. 6 months after surgery. Numerical Scale of pain (0 to 10) 0 : no pain - better outcome 10 : max of pain - worse outcome
Postoperative nausea and vomiting In Post Interventional Care Unit - after the surgery- presence or absence
Opioïd dose received - Per-operative Per-operative Evaluation in milligrammes
Opioïd dose received during the first post-operative 24 hours in the surgery department Evaluation in milligrammes
Screening of neuropathic pain if persistent postoperative pain - 6 months 6 months after surgery. 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
Trial Locations
- Locations (1)
CHU Nantes
🇫🇷Nantes, France