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| Name | Class |
|---|---|
| Fondation Apicil | OTHER |
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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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loco-Regional Analgesia | Experimental | Patients will receive Loco-Regional Analgesia during General Anesthesia, and systemic analgesia if necessary
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| Systemic Analgesia Only | Active Comparator | Patients will just receive General Anesthesia and systemic analgesia. _ Profofol and/or Suxaméthonium and/or Sévoflurane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbocaine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Persistent Postoperative Pain | Numerical Scale of pain superior to 3 (0 to 10). 0 : no pain - better outcome 10 : max of pain - worse outcome | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rémi Bernardon | Contact | +33(0)2 43 48 22 15 | remi.bernardon@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nantes | Recruiting | Nantes | France |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008619 | Mepivacaine |
| D018681 | Anesthetics, General |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000777 | Anesthetics |
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|
| Profofol and/or Suxaméthonium and/or Sévoflurane | Drug | General anesthesia Anesthetic induction is performed on a full stomach using :
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. |
|
|
| 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 |
| 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 | 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 | 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 | 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 | 12 months after surgery. |
| Postoperative nausea and vomiting | presence or absence | In Post Interventional Care Unit - after the surgery- |
| Time in Post Interventional Care Unit | Evaluation in minutes. | In Post Interventional Care Unit - after the surgery - |
| Opioïd dose received - Per-operative | Evaluation in milligrammes | Per-operative |
| Opioïd dose received - in Post Interventional Care Unit | Evaluation in milligrammes | in Post Interventional Care Unit after the surgery- |
| Opioïd dose received | Evaluation in milligrammes | during the first post-operative 24 hours in the surgery department |
| Intravenous Morphine dose received in Post Interventional Care Unit | Evaluation in milligrammes | in Post Interventional Care Unit after the surgery- |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002492 |
| Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |