Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519929
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Analgesic Techniques for Rib Fractures
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study Comparing Three Analgesia Approaches for Rib Fractures
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be a 3-arm parallel-group randomized controlled trial comparing three analgesic techniques for rib fractures with a sample size of 24 patients 8 per group Patients will be randomly assigned to one of the following three groups 1 ESP block with catheter using ropivacaine bolus followed by continuous infusion 2 lidocaine bolus 1 mgkg and infusion starting at 1 mgkgh or 3 standard care with multimodal analgesia and opioids
Our specific aims are
1 To compare the opioid use and pain ratings over the first 72 hours after enrollment
2 To quantify the changes in vital capacity oxygen requirement and freedom from mechanical ventilation that result from the intervention
3 To explore the impact of ESP blocks and lidocaine infusions on the development of chronic pain and post-discharge opioid use exploratory
Inclusion Criteria
Adult patients 55 years old who have sustained 3 or more unilateral rib fractures and are admitted to the hospital
Exclusion Criteria
Allergy to amide local anesthetics lidocaine or ropivacaine
Pregnancy
Bilateral rib fractures
Coagulopathy INR 15 PTT 15 times ULN or platelets 75000
Conduction block on EKG
Total body weight 40 kg
Painful distracting injuries acute thoracic spine fracture severe traumatic brain injury or spinal cord injury unstable pelvic fracture open abdomen
Spine fracture at the level of intended ESP block
Infection near the ESP insertion site or active bacteremia or sepsis
Any patient deemed a poor candidate for ESP block andor lidocaine infusion will also be excluded
Our specific aims are
1 To compare the opioid use and pain ratings over the first 72 hours after enrollment
2 To quantify the changes in vital capacity oxygen requirement and freedom from mechanical ventilation that result from the intervention
3 To explore the impact of ESP blocks and lidocaine infusions on the development of chronic pain and post-discharge opioid use exploratory
Inclusion Criteria
Adult patients 55 years old who have sustained 3 or more unilateral rib fractures and are admitted to the hospital
Exclusion Criteria
Allergy to amide local anesthetics lidocaine or ropivacaine
Pregnancy
Bilateral rib fractures
Coagulopathy INR 15 PTT 15 times ULN or platelets 75000
Conduction block on EKG
Total body weight 40 kg
Painful distracting injuries acute thoracic spine fracture severe traumatic brain injury or spinal cord injury unstable pelvic fracture open abdomen
Spine fracture at the level of intended ESP block
Infection near the ESP insertion site or active bacteremia or sepsis
Any patient deemed a poor candidate for ESP block andor lidocaine infusion will also be excluded
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None