Rib FracturesPhase 2Rib Fract ESPNCT04707183
Comparison of Continuous Intravenous Lidocaine Infusion Versus ESP Block for Rib Fracture Analgesia
A Phase 2 study testing Lidocaine IV Infusion and 2% Lidocaine via ESPB in people with Rib Fractures, run by Stanford University at 1 site in United States.
Trial summary
Recently in 2016, a new interfascial plane nerve block was developed for thoracic analgesia known as the erector spinae plane block (ESPB). Since its development for thoracic neuropathic pain, the ESPB has been shown to be effective in pain control in multiple procedures including thoracotomies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rib Fractures
- What is being tested?
- Lidocaine IV Infusion and 2% Lidocaine via ESPB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2025to May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients admitted to Stanford Health Care with two or more acute traumatic rib fractures.
Who cannot join
- Hemodynamically instability,
- Mechanical ventilation,
- Polytrauma (defined as bone or organ injury outside the thorax),
- Pregnancy,
- Incarceration
- Local anesthetic allergy or contraindications to lidocaine (Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular block)
- Chronic opioid use.
Trial locations and contacts
1 site in 1 country.
About this study
Recently in 2016, a new interfascial plane nerve block was developed for thoracic analgesia known as the erector spinae plane block (ESPB). Since its development for thoracic neuropathic pain, the ESPB has been shown to be effective in pain control in multiple procedures including thoracotomies. However, there have been a few published case reports of using ESPB for analgesia in rib fracture management and only one retrospective study which demonstrated improved NRS pain scores and increased incentive spirometry volumes (ICV) post-ESPB compared to pre-ESPB values.
The goal of this study is to compare the effectiveness of ESPB as an alternative method to the current standard of care at Stanford Health Care (SHC) for pain management in traumatic rib fractures. At the investigator's institution, the current standard of care is intravenous (IV) and enteral multimodal analgesia that consists primarily of opioids and a continuous IV lidocaine infusion. Although IV lidocaine has shown some benefit in improving post-surgical pain scores, evidence for its use in MRF is lacking. The purpose of this study is to perform a randomized clinical trial comparing outcomes in pain control and incentive spirometry volumes between continuous ESPB catheters and IV lidocaine infusions in adult patients with acute traumatic rib fractures.
Read more
The investigators want to determine if ESPB can provide improved pain control in patients admitted for traumatic rib fractures compared to IV Lidocaine. The aim is to evaluate the clinical effectiveness of ESPB on OME consumption, pain scores, incentive spirometry volumes, cough strength, respiratory complications, inflammatory biomarkers and hospital LOS. Findings from this study can help improve analgesia, quality of care, and patient satisfaction at Stanford Healthcare and for other acute pain and trauma surgery providers.
The aim of this study involves pain management for patients with acute traumatic rib fractures and therefore must involve human subjects.
- Conditions
- Rib Fractures
- Being tested
- Lidocaine IV Infusion, 2% Lidocaine via ESPB
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine IV InfusionDrug
Also called Lidocaine
Lidocaine will infused through erector spinae plane block catheter in patients with traumatic rib fracture.
2% Lidocaine via ESPBDrug
10 ml of 2% lidocaine will be infused through ESPB in treatment group
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | 1.0mg/kg/hr IV lidocaine infusion Receives: Drug: Lidocaine IV Infusion |
| Treatment Arm | Experimental | 10 mL of 2% lidocaine via ESPB Receives: Drug: 2% Lidocaine via ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
OME consumption at 24 hours of treatment.
Oral morphine equivalent consumption at 24 hours of treatment
Measured: Up to 24 hours of treatment
Secondary outcomes (7)
OME at 48 hrs
Oral morphine equivalent consumption at 48 hours of treatment
Measured: Up to 48 hours of treatment
Pain Score
Pain scores at rest and with cough and deep inspiration. Will use Numeric Rating Scale (NRS) of 0-10, where 0 is no pain and 10 is the worst imaginable
Measured: Every 4 hours general pain scores, and baseline, 24 hours, 48 hour, 72 hours for pain scores with cough and inspiration.
Incentive spirometry volumes (volume of 0 - 5000 mL)
An incentive spirometer is a device that measures how deeply you can inhale. Higher volumes indicate greater ability to inhale.
Measured: Time 0, 24 hours, 48 hour, and 72 hours
PIC score
PIC score is a composite score comprising pain level, ISV, and cough strength. PIC scores range from 1-10 with one being severe pain, inability to perform incentive spirometry, and absent cough and 10 being controlled pain, an incentive spirometry volume above goal volume(set by respiratory therapist), and strong cough
Measured: Time 0, 24 hours, 48 hour, and 72 hours.
Length of hospital stay
We will record the number of days stayed at the hospital from the day of operation till the day of discharge (from 0-10, or 10+)
Measured: Up to 10 days
Inflammatory biomarkers
Will be looking at proinflammatory markers (IL6, IL8, IL-1β, TNF-α) and f anti-inflammatory markers (IL10)
Measured: Time 0, 24 hours, and 48 hour
Rates of pulmonary complications
We will look at the occurrence of complications such as ARDS, pneumonia, aspiration, empyema, including need for positive pressure ventilation, pneumonia, aspiration, supplemental oxygen
Measured: Will be assessed up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study startMay 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Xu, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707183
- Sponsor's protocol ID
- 53844
- Acronym
- Rib Fract ESP
- Status last verified
- Apr 2025
- First submitted
- 23 Dec 2020
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology. 2000 Sep;93(3):858-75. doi: 10.1097/00000542-200009000-00038. No abstract available.
PubMed 10969322
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Continuous Intravenous Lidocaine Infusion Versus ESP Block for Rib Fracture Analgesia
- ClinicalTrials.gov ID
- NCT04707183
- Acronym / sponsor ID
- Rib Fract ESP / 53844
- Conditions
- Rib Fractures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 13 Jan 2021 (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.
Recently in 2016, a new interfascial plane nerve block was developed for thoracic analgesia known as the erector spinae plane block (ESPB). Since its development for thoracic neuropathic pain, the ESPB has been shown to be effective in pain control in multiple procedures including thoracotomies. However, there have been a few published case reports of using ESPB for analgesia in rib fracture management and only one retrospective study which demonstrated improved NRS pain scores and increased incentive spirometry volumes (ICV) post-ESPB compared to pre-ESPB values.
The goal of this study is to compare the effectiveness of ESPB as an alternative method to the current standard of care at Stanford Health Care (SHC) for pain management in traumatic rib fractures. At the investigator's institution, the current standard of care is intravenous (IV) and enteral multimodal analgesia that consists primarily of opioids and a continuous IV lidocaine infusion. Although IV lidocaine has shown some benefit in improving post-surgical pain scores, evidence for its use in MRF is lacking. The purpose of this study is to perform a randomized clinical trial comparing outcomes in pain control and incentive spirometry volumes between continuous ESPB catheters and IV lidocaine infusions in adult patients with acute traumatic rib fractures.
The investigators want to determine if ESPB can provide improved pain control in patients admitted for traumatic rib fractures compared to IV Lidocaine. The aim is to evaluate the clinical effectiveness of ESPB on OME consumption, pain scores, incentive spirometry volumes, cough strength, respiratory complications, inflammatory biomarkers and hospital LOS. Findings from this study can help improve analgesia, quality of care, and patient satisfaction at Stanford Healthcare and for other acute pain and trauma surgery providers.
The aim of this study involves pain management for patients with acute traumatic rib fractures and therefore must involve human subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Drug: Lidocaine IV Infusion1.0mg/kg/hr IV lidocaine infusion |
| Treatment Arm | Experimental | Drug: 2% Lidocaine via ESPB10 mL of 2% lidocaine via ESPB |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients admitted to Stanford Health Care with two or more acute traumatic rib fractures.
Key exclusion criteria (7 listed)
- Hemodynamically instability,
- Mechanical ventilation,
- Polytrauma (defined as bone or organ injury outside the thorax),
- Pregnancy,
- Incarceration
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 |
|---|---|---|
| Lidocaine IV InfusionAlso: LidocaineLidocaine will infused through erector spinae plane block catheter in patients with traumatic rib fracture. | Drug | Control Arm |
| 2% Lidocaine via ESPB10 ml of 2% lidocaine will be infused through ESPB in treatment group | Drug | Treatment Arm |
Primary outcome
OME consumption at 24 hours of treatment.
Time frame: Up to 24 hours of treatment
Oral morphine equivalent consumption at 24 hours of treatment
7 secondary outcomes
OME at 48 hrs
Time frame: Up to 48 hours of treatment
Pain Score
Time frame: Every 4 hours general pain scores, and baseline, 24 hours, 48 hour, 72 hours for pain scores with cough and inspiration.
Incentive spirometry volumes (volume of 0 - 5000 mL)
Time frame: Time 0, 24 hours, 48 hour, and 72 hours
PIC score
Time frame: Time 0, 24 hours, 48 hour, and 72 hours.
Length of hospital stay
Time frame: Up to 10 days
Inflammatory biomarkers
Time frame: Time 0, 24 hours, and 48 hour
Rates of pulmonary complications
Time frame: Will be assessed up to 72 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 10969322Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology. 2000 Sep;93(3):858-75. doi: 10.1097/00000542-200009000-00038. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine IV Infusion and 2% Lidocaine via ESPB in people with Rib Fractures, run by Stanford 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 1 inclusion and 7 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: withdrawn, as of the sponsor's last update on 5 May 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
OME consumption at 24 hours of treatment. (time frame: Up to 24 hours of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04707183, which also lists 1 linked publication.
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 5 May 2026.