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".
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
208
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.
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.
CHU Nantes
Nantes, France
RECRUITINGPersistent Postoperative Pain
Numerical Scale of pain superior to 3 (0 to 10). 0 : no pain - better outcome 10 : max of pain - worse outcome
Time frame: 3 months after surgery
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months after surgery.
Postoperative nausea and vomiting
presence or absence
Time frame: In Post Interventional Care Unit - after the surgery-
Time in Post Interventional Care Unit
Evaluation in minutes.
Time frame: In Post Interventional Care Unit - after the surgery -
Opioïd dose received - Per-operative
Evaluation in milligrammes
Time frame: Per-operative
Opioïd dose received - in Post Interventional Care Unit
Evaluation in milligrammes
Time frame: in Post Interventional Care Unit after the surgery-
Opioïd dose received
Evaluation in milligrammes
Time frame: during the first post-operative 24 hours in the surgery department
Intravenous Morphine dose received in Post Interventional Care Unit
Evaluation in milligrammes
Time frame: in Post Interventional Care Unit after the surgery-
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