Rib FracturesPhase 4NCT04558281
Continuous Erector Spinae Plane Blocks for Rib Fractures
A Phase 4 study testing Active ropivacaine 0.3% erector spinae plane perineural administration in people with Rib Fractures and Trauma, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures, Trauma, Anesthesia
- What is being tested?
- Active ropivacaine 0.3% erector spinae plane perineural administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2021to 24 Mar 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having a total of 1-6 rib fractures at least 3 cm distal to the costo-transverse joint (bilateral fractures are acceptable, but the total of the two sides combined must not exceed 6 fractures)
- regional anesthetic requested by the admitting service
- patient accepting of a perineural catheter insertion and subsequent study fluid treatment.
Who cannot join
- chronic opioid use (daily use within the 2 weeks prior to presentation and duration of use > 4 weeks; of note, any testing for opioid use will not occur as part of the study, but may as standard of care)
- pregnancy
- incarceration
- inability to communicate with the investigators
- weight < 45 kg or morbid obesity (body mass index > 40 kg/m2)
- comorbidity precluding either perineural catheter insertion or subsequent ambulatory perineural local anesthetic administration (e.g., current infection at the catheter insertion site, known hepatic or renal insufficiency, immune-compromised status of any etiology)
Show all 14Show fewer
- any patient unable to correctly perform incentive spirometry as this is the primary outcome measure
- any patient with any degree of decreased mental capacity as determined by the surgical service
- any reason an investigator believes study participation would not be in the best interest of the potential subject
- flail chest
- chest tube
- fracture of the 1st rib on either side
- any injury other than the rib fracture(s) that potentially effects inspiratory effort or volume (e.g., clavicle fracture)
- inability to contact the investigators during the perineural administration, and vice versa (e.g., lack of telephone access).
Trial locations and contacts
1 site in 1 country.
United States1 site
University California San Diego
San Diego, California, 92103
About this study
Official title: Continuous Erector Spinae Plane Blocks for Analgesia and Improving Incentive Spirometry Following Traumatic Rib Fractures
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.
Read more
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.
Read the 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 fracture(s) 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 0.5% (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 (1:1 ratio in blocks of 2):
- active (ropivacaine 0.3%)
- 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 mL/h 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 0.5, 1, 1.5, 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 fracture(s).
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 fracture(s).
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].
- Conditions
- Rib Fractures, Trauma, Anesthesia, Anesthesia, Local
- Being tested
- Active ropivacaine 0.3% erector spinae plane perineural administration, Placebo erector spinae plane perineural administration
- Medical subject headings
- Rib Fractures, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ropivacaine 0.3% erector spinae plane perineural administrationDrug
Ropivacaine 0.3% administration via an erector spinae plane perineural catheter
Placebo erector spinae plane perineural administrationDrug
Normal saline administration via an erector spinae plane perineural catheter
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block) Receives: Drug: Active ropivacaine 0.3% erector spinae plane perineural administration |
| Placebo | Placebo comparator | This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline Receives: Drug: Placebo erector spinae plane perineural administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspired Volume - Absolute
Measured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume.
Measured: Between 1200 and 1700 on the day following the procedure
Secondary outcomes (10)
Maximal Inspired Volume - Absolute
Measured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume.
Measured: Afternoons on postoperative days 2 and 7, postoperative months 0.5, 1, 1.5, 2, 3, 6, and 12
Maximal Inspired Volume - Percentage Change From Baseline Prior to Intervention
Measured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume.
Measured: Afternoons on postoperative days 1, 2 and 7, postoperative months 0.5, 1, 1.5, 2, 3, 6, and 12
Brief Pain Inventory (Short Form, Interference Subscale)
The Brief Pain Inventory (short form, Interference scale) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning [7 questions related specifically to rib fracture pain and not other injuries]. We calculated the total score of the 7 questions combined. The minimum is zero (no interference, better outcome) and the maximum is 70 (maximum interference, worse outcome).
Measured: Months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
Rib Fracture Pain When Using an Incentive Spirometer
Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Measured: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
WORST Rib Fracture Pain in Previous 24 Hours
Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Measured: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
AVERAGE Rib Fracture Pain in Previous 24 Hours
Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Measured: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
LEAST Rib Fracture Pain in Previous 24 Hours
Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Measured: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
CURRENT Rib Fracture Pain in Previous 24 Hours
Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Measured: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
Opioid Consumption
Amount of opioid used in last 24 hours (ultimately measured in morphine equivalents)
Measured: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
Sleep Disturbances Due to Rib Fracture Pain
Number of awakenings due to rib fracture pain the previous night
Measured: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start23 May 2021
- Primary completion26 Mar 2022
- Study completion24 Mar 2023
Why it stopped: Could only enroll 4 subjects in nearly 2 years
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-masked, placebo-controlled, parallel group clinical study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian M. Ilfeld, MD, MS, University of California, San Diego
- Investigators
- John J Finneran IV, MD, Study director, University of California, San DiegoBrian M Ilfeld, MD, MS, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558281
- Sponsor's protocol ID
- cESPB for Rib Fractures
- Status last verified
- May 2023
- First submitted
- 13 Sep 2020
- Last updated
- 12 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Erector Spinae Plane Blocks for Analgesia and Improving Incentive Spirometry Following Traumatic Rib Fractures
- ClinicalTrials.gov ID
- NCT04558281
- Acronym / sponsor ID
- cESPB for Rib Fractures
- Conditions
- Rib Fractures, Trauma, Anesthesia, Anesthesia, Local
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Could only enroll 4 subjects in nearly 2 years
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 23 May 2021 (actual)
- Primary completion
- 26 Mar 2022 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Posted 12 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 fracture(s) 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 0.5% (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 (1:1 ratio in blocks of 2):
- active (ropivacaine 0.3%)
- 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 mL/h 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 0.5, 1, 1.5, 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 fracture(s).
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 fracture(s).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-masked, placebo-controlled, parallel group clinical study
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Drug: Active ropivacaine 0.3% erector spinae plane perineural administrationThis group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block) |
| Placebo | Placebo comparator | Drug: Placebo erector spinae plane perineural administrationThis group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- having a total of 1-6 rib fractures at least 3 cm distal to the costo-transverse joint (bilateral fractures are acceptable, but the total of the two sides combined must not exceed 6 fractures)
- regional anesthetic requested by the admitting service
- patient accepting of a perineural catheter insertion and subsequent study fluid treatment.
Key exclusion criteria (14 listed)
- chronic opioid use (daily use within the 2 weeks prior to presentation and duration of use > 4 weeks; of note, any testing for opioid use will not occur as part of the study, but may as standard of care)
- pregnancy
- incarceration
- inability to communicate with the investigators
- weight < 45 kg or morbid obesity (body mass index > 40 kg/m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active ropivacaine 0.3% erector spinae plane perineural administrationRopivacaine 0.3% administration via an erector spinae plane perineural catheter | Drug | Active Treatment |
| Placebo erector spinae plane perineural administrationNormal saline administration via an erector spinae plane perineural catheter | Drug | Placebo |
Primary outcome
Maximal Inspired Volume - Absolute
Time frame: Between 1200 and 1700 on the day following the procedure
Measured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume.
10 secondary outcomes
Maximal Inspired Volume - Absolute
Time frame: Afternoons on postoperative days 2 and 7, postoperative months 0.5, 1, 1.5, 2, 3, 6, and 12
Maximal Inspired Volume - Percentage Change From Baseline Prior to Intervention
Time frame: Afternoons on postoperative days 1, 2 and 7, postoperative months 0.5, 1, 1.5, 2, 3, 6, and 12
Brief Pain Inventory (Short Form, Interference Subscale)
Time frame: Months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
Rib Fracture Pain When Using an Incentive Spirometer
Time frame: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
WORST Rib Fracture Pain in Previous 24 Hours
Time frame: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
AVERAGE Rib Fracture Pain in Previous 24 Hours
Time frame: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
LEAST Rib Fracture Pain in Previous 24 Hours
Time frame: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
CURRENT Rib Fracture Pain in Previous 24 Hours
Time frame: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
Opioid Consumption
Time frame: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
Sleep Disturbances Due to Rib Fracture Pain
Time frame: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J Finneran IV, MD study director
University of California, San Diego
Brian M Ilfeld, MD, MS principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Active ropivacaine 0.3% erector spinae plane perineural administration in people with Rib Fractures and Trauma, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspired Volume - Absolute (time frame: Between 1200 and 1700 on the day following the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.