Ignite Creation Date:
2024-05-06 @ 2:34 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04359017
Status:
WITHDRAWN
Last Update Posted:
2023-12-18
First Post:
2020-04-17
Brief Title:
Systemic Absorption of Lidocaine After Hematoma Block
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Systemic Absorption of Lidocaine After Ultrasound Guided Hematoma Block for Reduction of Different Types of Pediatric Distal Radius Fractures
Status:
WITHDRAWN
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsoring staff have left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will measure in children how much numbing medicine lidocaine is absorbed into the bloodstream after it is injected into a blood clot hematoma around a forearm fracture for pain control when the broken bone is moved back into place fracture reduction This is called a hematoma block and is commonly used in the Emergency Unit To help with anxiety and to add additional pain control nitrous oxide laughing gas is given while the lidocaine hematoma block is placed and continued during the fracture reduction Advantages of using this technique for pain control instead of an intravenous anesthetic such as ketamine include faster recovery and discharge home and longer pain control
Of concern if too much lidocaine is absorbed into the bloodstream seizures and irregular heart beating may occur Bloodstream concentrations of lidocaine after a hematoma block have been measured in only one study of 8 adults and found to be at significant but safe levels No study has been published in children to measure bloodstream lidocaine levels when a hematoma block is used Because childrens bones are still growing and more metabolically active than adult bones the investigators believe it is important to determine whether lidocaine blood levels in children are also at safe levels when using a standard lidocaine hematoma block for reduction of fractures The investigators also want to determine whether bloodstream lidocaine levels correlate with type of fracture
The investigators also aim to determine if there is a difference in absorption pattern between different types of distal radius fractures if there is a correlation between fracture type and systemic lidocaine absorption and if there is a correlation between fracture type and ability to provide adequate pain and sedation control with lidocaine hematoma blockinhaled nitrous combination The investigators believe blood lidocaine levels after hematoma block in children will peak at safe levels but will be higher than those observed in adults
Of concern if too much lidocaine is absorbed into the bloodstream seizures and irregular heart beating may occur Bloodstream concentrations of lidocaine after a hematoma block have been measured in only one study of 8 adults and found to be at significant but safe levels No study has been published in children to measure bloodstream lidocaine levels when a hematoma block is used Because childrens bones are still growing and more metabolically active than adult bones the investigators believe it is important to determine whether lidocaine blood levels in children are also at safe levels when using a standard lidocaine hematoma block for reduction of fractures The investigators also want to determine whether bloodstream lidocaine levels correlate with type of fracture
The investigators also aim to determine if there is a difference in absorption pattern between different types of distal radius fractures if there is a correlation between fracture type and systemic lidocaine absorption and if there is a correlation between fracture type and ability to provide adequate pain and sedation control with lidocaine hematoma blockinhaled nitrous combination The investigators believe blood lidocaine levels after hematoma block in children will peak at safe levels but will be higher than those observed in adults
Detailed Description:
When a subject with an eligible distal forearm fracture is identified the subject will be approached for enrollment and consent
50 nitrous oxide50 oxygen then will be administered to the subject by face mask for a minimum of 2 minutes before venous catheter insertion 50 nitrous oxide will continue to be administered until fracture reduction is completed Nitrous oxide currently is administered regularly in the St Louis Childrens Emergency Department for painful procedures including fracture reduction abscess incision and drainage laceration repair and venous catheter placement Nitrous oxide 50 blended with 50 oxygen will be administered for this study by credentialed emergency unit staff using a continuous flow delivery system that includes scavenging of exhaled nitrous oxide Standard monitoring for deep sedation will be used as described in the clinical protocol
A venous catheter then will be inserted into the uninjured arm A lidocaine hematoma block will be injected under ultrasound guidance by a pediatric emergency medicine physician using 25 mgkg maximum of 100mg of 1 buffered lidocaine The recommended lidocaine dose for hematoma block in children is 3-5 mgkg However in a previous study in another pediatric trial and in the single report of plasma lidocaine levels in adults 25 mgkg of 1 lidocaine based upon the patients weight maximum 100 mg was found effective and without adverse effects The Pediatric Sedation State Scale will be administered by the sedation provider and a research assistant when available and used to determine if pain control is adequate or if rescue IV analgesia is needed This scale has been validated for procedural sedation
Serial blood samples will be drawn through the indwelling venous catheter by a nurse or medic at 5 10 20 40 and 60 minutes after injection of the hematoma block Serial plasma lidocaine levels will be measured as follows 5 mL samples of blood will be obtained via the indwelling venous catheter at 5 10 20 40 and 60 minutes after injection of the lidocaine hematoma block The samples of blood will be collected in standard red top vacutainer blood tubes and processed frozen and stored in the SLCHBJC Lab
At 5 minutes after the hematoma block injection the orthopedic surgeon will attempt fracture reduction If the subject has minimal response to squeezing the fracture site prior to 5 minutes post injection reduction may begin at that time Nitrous oxide administration will be stopped and administration of 100 oxygen will begin when the orthopedic surgeon indicates satisfactory fracture reduction as determined by bedside fluoroscopy standard procedure a cast or splint has been applied and if necessary the cast has been split Oxygen administration will be stopped when the subjects exhaled nitrous oxide concentration falls below 10 or the subject pulls the nitrous oxide mask off the face
If the subject resists the fracture reduction verbally indicates significant pain or has an unfavorable PSSS ketamine sedation will be administered via the indwelling venous catheter and fracture reduction completed under deep sedation Post procedure pain score via the Wong-Baker Faces scale and post procedure surveys will be administered 15 minutes after nitrous administration is stopped After the subjects recovery from sedation the subject subjects parentsguardians physician providing sedation inhaled nitrous and the orthopedic surgeon will be asked to rate their satisfaction with the sedation and analgesia for the fracture reduction using a Likert scale ranging from 1 not satisfied at all to 10 very satisfied Recovery from sedation satisfactory for discharge home is indicated by a score of 10 on the Modified Aldrete Scale below and the child can sit up unaided along with control of pain and vomiting Family will be contacted via telephone 48 hours after their visit to assess for any late adverse effects
Adverse events will be documented on a data collection sheet using consensus-based definitions that include the event time and any intervention employed In addition the subject will be asked about symptoms typically seen with procedural sedation and lidocaine toxicity including vomiting nausea tinnitus circumoral or tongue numbness metallic taste in mouth nystagmus vision changes muscle twitching tremors seizure respiratory depression chest pain difficulty breathing palpitations ECG changes on monitor type noted ECG strip printed and any other unpleasant or euphoric symptom
50 nitrous oxide50 oxygen then will be administered to the subject by face mask for a minimum of 2 minutes before venous catheter insertion 50 nitrous oxide will continue to be administered until fracture reduction is completed Nitrous oxide currently is administered regularly in the St Louis Childrens Emergency Department for painful procedures including fracture reduction abscess incision and drainage laceration repair and venous catheter placement Nitrous oxide 50 blended with 50 oxygen will be administered for this study by credentialed emergency unit staff using a continuous flow delivery system that includes scavenging of exhaled nitrous oxide Standard monitoring for deep sedation will be used as described in the clinical protocol
A venous catheter then will be inserted into the uninjured arm A lidocaine hematoma block will be injected under ultrasound guidance by a pediatric emergency medicine physician using 25 mgkg maximum of 100mg of 1 buffered lidocaine The recommended lidocaine dose for hematoma block in children is 3-5 mgkg However in a previous study in another pediatric trial and in the single report of plasma lidocaine levels in adults 25 mgkg of 1 lidocaine based upon the patients weight maximum 100 mg was found effective and without adverse effects The Pediatric Sedation State Scale will be administered by the sedation provider and a research assistant when available and used to determine if pain control is adequate or if rescue IV analgesia is needed This scale has been validated for procedural sedation
Serial blood samples will be drawn through the indwelling venous catheter by a nurse or medic at 5 10 20 40 and 60 minutes after injection of the hematoma block Serial plasma lidocaine levels will be measured as follows 5 mL samples of blood will be obtained via the indwelling venous catheter at 5 10 20 40 and 60 minutes after injection of the lidocaine hematoma block The samples of blood will be collected in standard red top vacutainer blood tubes and processed frozen and stored in the SLCHBJC Lab
At 5 minutes after the hematoma block injection the orthopedic surgeon will attempt fracture reduction If the subject has minimal response to squeezing the fracture site prior to 5 minutes post injection reduction may begin at that time Nitrous oxide administration will be stopped and administration of 100 oxygen will begin when the orthopedic surgeon indicates satisfactory fracture reduction as determined by bedside fluoroscopy standard procedure a cast or splint has been applied and if necessary the cast has been split Oxygen administration will be stopped when the subjects exhaled nitrous oxide concentration falls below 10 or the subject pulls the nitrous oxide mask off the face
If the subject resists the fracture reduction verbally indicates significant pain or has an unfavorable PSSS ketamine sedation will be administered via the indwelling venous catheter and fracture reduction completed under deep sedation Post procedure pain score via the Wong-Baker Faces scale and post procedure surveys will be administered 15 minutes after nitrous administration is stopped After the subjects recovery from sedation the subject subjects parentsguardians physician providing sedation inhaled nitrous and the orthopedic surgeon will be asked to rate their satisfaction with the sedation and analgesia for the fracture reduction using a Likert scale ranging from 1 not satisfied at all to 10 very satisfied Recovery from sedation satisfactory for discharge home is indicated by a score of 10 on the Modified Aldrete Scale below and the child can sit up unaided along with control of pain and vomiting Family will be contacted via telephone 48 hours after their visit to assess for any late adverse effects
Adverse events will be documented on a data collection sheet using consensus-based definitions that include the event time and any intervention employed In addition the subject will be asked about symptoms typically seen with procedural sedation and lidocaine toxicity including vomiting nausea tinnitus circumoral or tongue numbness metallic taste in mouth nystagmus vision changes muscle twitching tremors seizure respiratory depression chest pain difficulty breathing palpitations ECG changes on monitor type noted ECG strip printed and any other unpleasant or euphoric symptom
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?:
False
Is an FDA AA801 Violation?:
None