Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04558281
Status:
TERMINATED
Last Update Posted:
2023-06-12
First Post:
2020-09-13
Brief Title:
Continuous Erector Spinae Plane Blocks for Rib Fractures
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Continuous Erector Spinae Plane Blocks for Analgesia and Improving Incentive Spirometry Following Traumatic Rib Fractures
Status:
TERMINATED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Could only enroll 4 subjects in nearly 2 years
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rib fractures are one of the most common injuries in trauma patients These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions which together lead to complications of the lungs and breathing which leads to risks of further injury and even death
One recent study found that the ability to move air into and out of the lungs practically doubled with the administration of a single-injection Erector Spainae Plane Block ESPB while pain levels nearly halved However a single-injection nerve block lasts less than 24 hours while a perineural local anesthetic infusion also termed a continuous peripheral nerve block may be administered for multiple days This entails inserting a tiny tube through the skin and into the area around the nerves after which more local anesthetic may be administered prolonging the numbing effects
The possibility of extending the duration of a ESPB with local anesthetic administration via a perineural catheter has not be investigated We therefore are conducting a randomized triple-masked placebo-controlled parallel-arm study to investigate the addition of a continuous ESPB to a single-injection ESPB following traumatic rib fractures
The primary outcome of this study will be the maximum inspired volume measured by incentive spirometry on the afternoon following the nerve block procedure We hypothesize that the maximum inspired volume will be significantly increased in the afternoon following the procedure with the addition of a continuous ESPB to a single-injection ESPB
One recent study found that the ability to move air into and out of the lungs practically doubled with the administration of a single-injection Erector Spainae Plane Block ESPB while pain levels nearly halved However a single-injection nerve block lasts less than 24 hours while a perineural local anesthetic infusion also termed a continuous peripheral nerve block may be administered for multiple days This entails inserting a tiny tube through the skin and into the area around the nerves after which more local anesthetic may be administered prolonging the numbing effects
The possibility of extending the duration of a ESPB with local anesthetic administration via a perineural catheter has not be investigated We therefore are conducting a randomized triple-masked placebo-controlled parallel-arm study to investigate the addition of a continuous ESPB to a single-injection ESPB following traumatic rib fractures
The primary outcome of this study will be the maximum inspired volume measured by incentive spirometry on the afternoon following the nerve block procedure We hypothesize that the maximum inspired volume will be significantly increased in the afternoon following the procedure with the addition of a continuous ESPB to a single-injection ESPB
Detailed Description:
Rib fractures are one of the most common injuries in trauma patients These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions which together lead to complications of the lungs and breathing which leads to risks of further injury and even death
The erector spinae plane block ESPB is a nerve block that covers multiple rib fractures with a single injection This block entails injecting local anesthetic in the back superficial to the vertebral bodies One study found that the ability to move air into and out of the lungs practically doubled with the administration of a single-injection ESPB while pain levels nearly halved
A single-injection nerve block lasts less than 24 hours while a perineural local anesthetic infusion also termed a continuous peripheral nerve block may be administered for multiple days This entails inserting a tiny tube through the skin and into the area around the nerves after which more local anesthetic may be administered prolonging the numbing effects The possibility of extending the duration of a ESPB with local anesthetic administration via a perineural catheter has not be investigated
We therefore are conducting a randomized tripe-masked placebo-controlled parallel-arm study to investigate the addition of a continuous ESPB to a single-injection ESPB following traumatic rib fracture Subjects will be individuals who present with rib fractures and significant pain Those who consent to participate in this study will have an ESP catheter inserted using ultrasound-guidance on the ipsilateral side at the level of the inferior-most fracture For bilateral fractures a second catheter will also be inserted on the remaining side The single-injection ESPB will be administered to each catheter with 20 mL of ropivacaine 05 with epinephrine
Subjects with an accurately-inserted catheter based on visualization of local anesthetic spread will be allocated to one of two possible perineural treatments stratified by unilateral vs bilateral fractures 11 ratio in blocks of 2
1 active ropivacaine 03
2 placebo normal saline
Computer-generated randomization lists will be created by the UCSD Investigational Drug Service which will keep the randomization lists and not release them to the investigators until the study is completed at which time they will provide lists of subjects who received Treatment A and Treatment B so that the statistician can analyze the data Only after the analysis is complete will Treatment A and Treatment B be defined for the investigators for manuscript preparation producing a triple-masked study Of note for bilateral catheters the treatments on both sides will always be identical each subject will be randomized to a single treatment and not each side of bilateral cases
Subjects will receive a basal infusion of study fluid ropivacaine vs placebo 1 mLh to keep the catheter lumen patent as soon as the infusion pump is initiated with a 500 mL reservoir In addition intermittent boluses 13 mL programmed automatic bolus every 2 hours will begin 5 hours after pump initiation For bilateral catheters a 6-hour delay for one of the pumps will ensure that the pair of pumps alternate sides for the bolus doses each hour This protocol will provide nearly 71-72 hours of study fluid administration
Following local anesthetic reservoir exhaustion subjects or their caretakers will remove the catheters with instructions provided by phone This is standard at UC San Diego for all ambulatory continuous peripheral nerve blocks and will not be unique to study participation The catheter is disposable in the trash and the infusion pump will be returned using a pre-addressed and postage-paid envelope provided to subjects prior to leaving the hospital
Subjects will be contacted by telephone to collect study data on post procedure days 1 2 7 and at months 05 1 15 2 3 6 and 12
The ultimate objective of the proposed line of research is to determine if the addition of a continuous ESPB to a single-injection ESPB prolongs analgesia following traumatic rib fractures and if this analgesic intervention improves pulmonary mechanics measured with incentive spirometry
Specific Aim 1 To determine if the addition of a continuous ESPB to a single-injection ESPB improves maximum inspiratory volume following traumatic rib fractures
Hypothesis 1a The maximum inspired volume will be significantly increased in the afternoon following the procedure primary endpoint as well as at other time points following the procedure secondary end points with the addition of a continuous ESPB to a single-injection ESPB measured with an incentive spirometer
Hypothesis 1b The maximum inspired volume as a percentage of the baseline will be significantly increased in the afternoon following the procedure secondary endpoint of greatest interest as well as at other time points following the procedure secondary end points with the addition of a continuous ESPB to a single-injection ESPB measured with an incentive spirometer
Specific Aim 2 To determine if the addition of a continuous ESPB to a single-injection ESPB decreases the pain associated with rib fractures
Hypothesis 2a The severity of rib fracture pain at rest will be significantly decreased within the 12 months following the procedure with the addition of a continuous ESPB to a single-injection ESPB measured using the Numeric Rating Scale for pain
Hypothesis 2b The severity of rib fracture pain when using the spirometer or coughing will be significantly decreased within the 12 months following the procedure with the addition of a continuous ESPB to a single-injection ESPB measured using the Numeric Rating Scale for pain
Hypothesis 2c The incidence of chronic rib fracture pain will be significantly decreased 6 and 12 months following a rib fracture with the addition of a continuous ESPB to a single-injection ESPB measured using the Numeric Rating Scale for pain
Hypothesis 2d The severity of chronic rib fracture pain will be significantly decreased 6 and 12 months following a rib fracture with the addition of a continuous ESPB to a single-injection ESPB measured using the Numeric Rating Scale for pain
The erector spinae plane block ESPB is a nerve block that covers multiple rib fractures with a single injection This block entails injecting local anesthetic in the back superficial to the vertebral bodies One study found that the ability to move air into and out of the lungs practically doubled with the administration of a single-injection ESPB while pain levels nearly halved
A single-injection nerve block lasts less than 24 hours while a perineural local anesthetic infusion also termed a continuous peripheral nerve block may be administered for multiple days This entails inserting a tiny tube through the skin and into the area around the nerves after which more local anesthetic may be administered prolonging the numbing effects The possibility of extending the duration of a ESPB with local anesthetic administration via a perineural catheter has not be investigated
We therefore are conducting a randomized tripe-masked placebo-controlled parallel-arm study to investigate the addition of a continuous ESPB to a single-injection ESPB following traumatic rib fracture Subjects will be individuals who present with rib fractures and significant pain Those who consent to participate in this study will have an ESP catheter inserted using ultrasound-guidance on the ipsilateral side at the level of the inferior-most fracture For bilateral fractures a second catheter will also be inserted on the remaining side The single-injection ESPB will be administered to each catheter with 20 mL of ropivacaine 05 with epinephrine
Subjects with an accurately-inserted catheter based on visualization of local anesthetic spread will be allocated to one of two possible perineural treatments stratified by unilateral vs bilateral fractures 11 ratio in blocks of 2
1 active ropivacaine 03
2 placebo normal saline
Computer-generated randomization lists will be created by the UCSD Investigational Drug Service which will keep the randomization lists and not release them to the investigators until the study is completed at which time they will provide lists of subjects who received Treatment A and Treatment B so that the statistician can analyze the data Only after the analysis is complete will Treatment A and Treatment B be defined for the investigators for manuscript preparation producing a triple-masked study Of note for bilateral catheters the treatments on both sides will always be identical each subject will be randomized to a single treatment and not each side of bilateral cases
Subjects will receive a basal infusion of study fluid ropivacaine vs placebo 1 mLh to keep the catheter lumen patent as soon as the infusion pump is initiated with a 500 mL reservoir In addition intermittent boluses 13 mL programmed automatic bolus every 2 hours will begin 5 hours after pump initiation For bilateral catheters a 6-hour delay for one of the pumps will ensure that the pair of pumps alternate sides for the bolus doses each hour This protocol will provide nearly 71-72 hours of study fluid administration
Following local anesthetic reservoir exhaustion subjects or their caretakers will remove the catheters with instructions provided by phone This is standard at UC San Diego for all ambulatory continuous peripheral nerve blocks and will not be unique to study participation The catheter is disposable in the trash and the infusion pump will be returned using a pre-addressed and postage-paid envelope provided to subjects prior to leaving the hospital
Subjects will be contacted by telephone to collect study data on post procedure days 1 2 7 and at months 05 1 15 2 3 6 and 12
The ultimate objective of the proposed line of research is to determine if the addition of a continuous ESPB to a single-injection ESPB prolongs analgesia following traumatic rib fractures and if this analgesic intervention improves pulmonary mechanics measured with incentive spirometry
Specific Aim 1 To determine if the addition of a continuous ESPB to a single-injection ESPB improves maximum inspiratory volume following traumatic rib fractures
Hypothesis 1a The maximum inspired volume will be significantly increased in the afternoon following the procedure primary endpoint as well as at other time points following the procedure secondary end points with the addition of a continuous ESPB to a single-injection ESPB measured with an incentive spirometer
Hypothesis 1b The maximum inspired volume as a percentage of the baseline will be significantly increased in the afternoon following the procedure secondary endpoint of greatest interest as well as at other time points following the procedure secondary end points with the addition of a continuous ESPB to a single-injection ESPB measured with an incentive spirometer
Specific Aim 2 To determine if the addition of a continuous ESPB to a single-injection ESPB decreases the pain associated with rib fractures
Hypothesis 2a The severity of rib fracture pain at rest will be significantly decreased within the 12 months following the procedure with the addition of a continuous ESPB to a single-injection ESPB measured using the Numeric Rating Scale for pain
Hypothesis 2b The severity of rib fracture pain when using the spirometer or coughing will be significantly decreased within the 12 months following the procedure with the addition of a continuous ESPB to a single-injection ESPB measured using the Numeric Rating Scale for pain
Hypothesis 2c The incidence of chronic rib fracture pain will be significantly decreased 6 and 12 months following a rib fracture with the addition of a continuous ESPB to a single-injection ESPB measured using the Numeric Rating Scale for pain
Hypothesis 2d The severity of chronic rib fracture pain will be significantly decreased 6 and 12 months following a rib fracture with the addition of a continuous ESPB to a single-injection ESPB measured using the Numeric Rating Scale for pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None