Persistent Postoperative Pain
Conditions
Keywords
Persistent Postoperative Pain, Post-surgical chronic pain, Children, Loco-regional Analgesia, Orthopedic surgery
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.
Interventions
DRUGCarbocaine
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.
DRUGProfofol and/or Suxaméthonium and/or Sévoflurane
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.
Sponsors
Fondation Apicil
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 183 Months
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Time in Post Interventional Care Unit | In Post Interventional Care Unit - after the surgery - | Evaluation in minutes. |
| Opioïd dose received - Per-operative | Per-operative | Evaluation in milligrammes |
| Opioïd dose received - in Post Interventional Care Unit | in Post Interventional Care Unit after the surgery- | Evaluation in milligrammes |
| Opioïd dose received | during the first post-operative 24 hours in the surgery department | Evaluation in milligrammes |
| Intravenous Morphine dose received in Post Interventional Care Unit | in Post Interventional Care Unit after the surgery- | Evaluation in milligrammes |
| Postoperative nausea and vomiting | In Post Interventional Care Unit - after the surgery- | presence or absence |
Countries
France
Contacts
Primary ContactRémi Bernardon
Outcome results
None listed