Rib FracturesPhase 4NCT06519929
Analgesic Techniques for Rib Fractures
A Phase 4 study testing ESP block with catheter using ropivacaine (bolus followed by continuous infusion) and Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h in people with Rib Fractures, run by Thomas Jefferson University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rib Fractures
- What is being tested?
- ESP block with catheter using ropivacaine (bolus followed by continuous infusion) and Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to 1 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 55 years old
- Sustained 3 or more unilateral rib fractures and are admitted to the hospital
Who cannot join
- Allergy to amide local anesthetics or any study medications
- Pregnancy
- Bilateral rib fractures
- Coagulopathy (INR > 1.5; platelets < 100,000)
- Conduction block on EKG
- 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 and/or lidocaine infusion will also be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Pilot Study Comparing Three Analgesia Approaches for Rib Fractures
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 mg/kg) and infusion starting at 1 mg/kg/h; or 3) standard care with multimodal analgesia and opioids.
Our specific aims are:
Read more
- To compare the opioid use and pain ratings over the first 72 hours after enrollment.
- To quantify the changes in vital capacity, oxygen requirement, and freedom from mechanical ventilation that result from the intervention.
- 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 > 1.5; PTT > 1.5 times ULN, or platelets < 75,000)
- 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 and/or lidocaine infusion will also be excluded
- Conditions
- Rib Fractures
- Being tested
- ESP block with catheter using ropivacaine (bolus followed by continuous infusion), Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP block with catheter using ropivacaine (bolus followed by continuous infusion)Procedure or surgery
A total of ropivacaine 75mg will be injected into the plane via the needle, followed by placement of a catheter 3-5 cm into the plane. A continuous infusion of ropivacaine 0.2% will be started at 8 mL/h and may be titrated up to a maximum of 10mL/h. Bolus doses of 5 mL using ropivacaine 0.2% will be permitted for breakthrough pain (pain score ≥ 7/10) and may be administered no more frequently than every 6 hours. Patients will be assessed for LAST twice daily by asking about tinnitus, perioral numbness, or metallic taste. Any patient who responds positively to these symptoms will have infusion stopped for 2 h and then restarted at a rate 2 mL/h lower. If the symptoms occur again, the catheter infusion will be stopped and the catheter removed. After the 72-hour study period the ESP catheter may remain in place if the patient has ongoing analgesia needs or if analgesia is controlled with oral medication the catheter may be removed at request of the treating team.
Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/hDrug
A bolus of 1 mg/kg based on ideal body weight will be given over 10 minutes with a physician present and infusions will be started at 1 mg/kg/h based on IBW. Infusions will run continuously for the first 72 h and can be continued beyond that at the discretion of the treating team if pain persists. Patients will be assessed for LAST twice daily. Any patient with suspected LAST will have lidocaine infusion stopped and a lidocaine plasma level will be sent. If symptoms resolve, the lidocaine infusion can be restarted at a rate 25% lower. If pain is refractory to the lidocaine infusion and multimodal adjuncts, the infusion may be increased to a maximum of 1.5 mg/kg/h (during first 24 h only). The actual duration of the infusion as well as total lidocaine dose given in mg will be recorded. Stopping criteria for lidocaine will include the occurrence of new EKG changes for which an alternative explanation is not more likely as well as LAST symptoms.
| Study group | Role | What they receive |
|---|---|---|
| ESP block with catheter using ropivacaine (bolus followed by continuous infusion) | Experimental | Not described Receives: Procedure: ESP block with catheter using ropivacaine (bolus followed by continuous infusion) |
| Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h | Active comparator | Not described Receives: Drug: Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h |
| Standard care with multimodal analgesia and opioids | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Use in oral morphine equivalents (OME)
This will include both IV and oral opioids. Opioids given via PCA will also be prospectively recorded and included.
Measured: 72 Hours
Brief Pain Inventory - current pain subscale (0-10)
The Brief Pain Inventory (short form) - average of all "current pain" ratings).
Measured: 0-72 Hours
Secondary outcomes (28)
Daily opioid use
The total daily opioid use will be recorded and converted to OMEs. The PDMP will be used to confirm if needed.
Measured: 30 Days
Daily opioid Use
The total daily opioid use will be recorded and converted to OMEs. The PDMP will be used to confirm if needed.
Measured: 90 Days
Brief Pain Inventory
Average pain (0-10) - this is the average of the "average pain" scores
Measured: Days 1-3
Brief Pain Inventory
Average pain (0-10)
Measured: Day 30
Brief Pain Inventory
Average pain (0-10)
Measured: Day 90
Vital capacity (mL)
Volume of air expired after a maximal inspiration in mL measured with spirometer
Measured: Baseline prior to intervention
Vital capacity (mL)
Volume of air expired after a maximal inspiration in mL measured with spirometer
Measured: Day 1
Vital capacity (mL)
Volume of air expired after a maximal inspiration in mL measured with spirometer
Measured: Day 2
Vital capacity (mL)
Volume of air expired after a maximal inspiration in mL measured with spirometer
Measured: Day 3
Duke Activity Status Index
Functional status assessment (0-60 with 60 representing the best function)
Measured: Baseline prior to intervention
Short-form 12
Functional status assessment (0-100 with 100 representing best function)
Measured: Baseline prior to intervention
Short-form 12
Functional status assessment (0-100 with 100 representing best function)
Measured: Day 30
Short-form 12
Functional status assessment (0-100 with 100 representing best function)
Measured: Day 90
3D-CAM/CAM-ICU
Delirium assessment (yes or no)
Measured: Day 1
3D-CAM/CAM-ICU
Delirium assessment (yes or no)
Measured: Day 2
3D-CAM/CAM-ICU
Delirium assessment (yes or no)
Measured: Day 3
Respiratory depression
Naloxone use
Measured: Days 1-3
Epidural eligibility
Clinical judgment of physician
Measured: Day 1
RibScore
Score includes: >= 6 ribs fractured, flail chest, bilateral fractures, first rib fracture, >= 3 displaced fractures, fracture in each anatomical area
Measured: Day 1
Presence of perioral numbness
Patient self report
Measured: Day 1
Presence of perioral numbness
Patient self report
Measured: Day 2
Presence of perioral numbness
Patient self report
Measured: Day 3
Presence of tinnitus
Patient self report
Measured: Day 1
Presence of tinnitus
Patient self report
Measured: Day 2
Presence of tinnitus
Patient self report
Measured: Day 3
Presence of metallic taste
Patient self report
Measured: Day 1
Presence of metallic taste
Patient self report
Measured: Day 2
Presence of metallic taste
Patient self report
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start23 Sep 2024
- Primary completion31 Aug 2025
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 3-arm, parallel-group, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Schwenk, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519929
- Sponsor's protocol ID
- IRISID-2022-1186
- Status last verified
- Sep 2025
- First submitted
- 16 Jul 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Comparing Three Analgesia Approaches for Rib Fractures
- ClinicalTrials.gov ID
- NCT06519929
- Acronym / sponsor ID
- IRISID-2022-1186
- Conditions
- Rib Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 mg/kg) and infusion starting at 1 mg/kg/h; or 3) standard care with multimodal analgesia and opioids.
Our specific aims are:
- To compare the opioid use and pain ratings over the first 72 hours after enrollment.
- To quantify the changes in vital capacity, oxygen requirement, and freedom from mechanical ventilation that result from the intervention.
- 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 > 1.5; PTT > 1.5 times ULN, or platelets < 75,000)
- 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 and/or lidocaine infusion will also be excluded
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3-arm, parallel-group, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| ESP block with catheter using ropivacaine (bolus followed by continuous infusion) | Experimental | Procedure: ESP block with catheter using ropivacaine (bolus followed by continuous infusion) |
| Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h | Active comparator | Drug: Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h |
| Standard care with multimodal analgesia and opioids | No intervention | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 55 years old
- Sustained 3 or more unilateral rib fractures and are admitted to the hospital
Key exclusion criteria (8 listed)
- Allergy to amide local anesthetics or any study medications
- Pregnancy
- Bilateral rib fractures
- Coagulopathy (INR > 1.5; platelets < 100,000)
- Conduction block on EKG
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 |
|---|---|---|
| ESP block with catheter using ropivacaine (bolus followed by continuous infusion)A total of ropivacaine 75mg will be injected into the plane via the needle, followed by placement of a catheter 3-5 cm into the plane. A continuous infusion of ropivacaine 0.2% will be started at 8 mL/h and may be titrated up to a maximum of 10mL/h. Bolus doses of 5 mL using ropivacaine 0.2% will be permitted for breakthrough pain (pain score ≥ 7/10) and may be administered no more frequently than every 6 hours. Patients will be assessed for LAST twice daily by asking about tinnitus, perioral numbness, or metallic taste. Any patient who responds positively to these symptoms will have infusion stopped for 2 h and then restarted at a rate 2 mL/h lower. If the symptoms occur again, the catheter infusion will be stopped and the catheter removed. After the 72-hour study period the ESP catheter may remain in place if the patient has ongoing analgesia needs or if analgesia is controlled with oral medication the catheter may be removed at request of the treating team. | Procedure or surgery | ESP block with catheter using ropivacaine (bolus followed by continuous infusion) |
| Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/hA bolus of 1 mg/kg based on ideal body weight will be given over 10 minutes with a physician present and infusions will be started at 1 mg/kg/h based on IBW. Infusions will run continuously for the first 72 h and can be continued beyond that at the discretion of the treating team if pain persists. Patients will be assessed for LAST twice daily. Any patient with suspected LAST will have lidocaine infusion stopped and a lidocaine plasma level will be sent. If symptoms resolve, the lidocaine infusion can be restarted at a rate 25% lower. If pain is refractory to the lidocaine infusion and multimodal adjuncts, the infusion may be increased to a maximum of 1.5 mg/kg/h (during first 24 h only). The actual duration of the infusion as well as total lidocaine dose given in mg will be recorded. Stopping criteria for lidocaine will include the occurrence of new EKG changes for which an alternative explanation is not more likely as well as LAST symptoms. | Drug | Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h |
Primary outcome
Opioid Use in oral morphine equivalents (OME)
Time frame: 72 Hours
This will include both IV and oral opioids. Opioids given via PCA will also be prospectively recorded and included.
Brief Pain Inventory - current pain subscale (0-10)
Time frame: 0-72 Hours
The Brief Pain Inventory (short form) - average of all "current pain" ratings).
28 secondary outcomes
Daily opioid use
Time frame: 30 Days
Daily opioid Use
Time frame: 90 Days
Brief Pain Inventory
Time frame: Days 1-3
Brief Pain Inventory
Time frame: Day 30
Brief Pain Inventory
Time frame: Day 90
Vital capacity (mL)
Time frame: Baseline prior to intervention
Vital capacity (mL)
Time frame: Day 1
Vital capacity (mL)
Time frame: Day 2
Vital capacity (mL)
Time frame: Day 3
Duke Activity Status Index
Time frame: Baseline prior to intervention
Short-form 12
Time frame: Baseline prior to intervention
Short-form 12
Time frame: Day 30
Short-form 12
Time frame: Day 90
3D-CAM/CAM-ICU
Time frame: Day 1
3D-CAM/CAM-ICU
Time frame: Day 2
3D-CAM/CAM-ICU
Time frame: Day 3
Respiratory depression
Time frame: Days 1-3
Epidural eligibility
Time frame: Day 1
RibScore
Time frame: Day 1
Presence of perioral numbness
Time frame: Day 1
Presence of perioral numbness
Time frame: Day 2
Presence of perioral numbness
Time frame: Day 3
Presence of tinnitus
Time frame: Day 1
Presence of tinnitus
Time frame: Day 2
Presence of tinnitus
Time frame: Day 3
Presence of metallic taste
Time frame: Day 1
Presence of metallic taste
Time frame: Day 2
Presence of metallic taste
Time frame: Day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Rib Fractures
Recruiting
Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
Traumatic Rib Fracture(s), Traumatic Rib Fracture
Active, not recruiting
Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
Rib Fractures, Blunt Chest Trauma
Not yet recruitingPhase 2/3
Comparison of Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Acute Pain Management in Patients With Traumatic Rib Fractures
Rib Fractures, Acute Pain
RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
Multiple Rib Fractures, Isolated Blunt Thoracic Trauma
Recruiting
Parascapular Sub Iliocostalis Plane Block Versus Thoracic Paravertebral Plane Block for Traumatic Multiple Rib Fractures
Discitis of Thoracic Region
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.
Eric Schwenk, MD principal investigator
Thomas Jefferson University
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 ESP block with catheter using ropivacaine (bolus followed by continuous infusion) and Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h in people with Rib Fractures, run by Thomas Jefferson University 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 2 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Opioid Use in oral morphine equivalents (OME) (time frame: 72 Hours). The study lists 2 primary outcomes in all. 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 9 Sep 2025.