Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271174
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-07-19
Brief Title:
Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AWA3PASIC
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None