Rib FracturesEarly Phase 1NCT04413799
PVB vs Ketamine/Lidocaine in Rib Fracture Patients
A Early Phase 1 study testing lidocaine, ketamine intravenous infusion and paravertebral block with ropivicaine in people with Rib Fractures and Rib Trauma, run by George Washington University at 1 site in United States.
Trial summary
Rib fractures are a common admission to the trauma service. The mainstay of treatment is pain control to improve respiratory effort in order to offset the risk of pneumonia and mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rib Fractures, Rib Trauma, Rib Fracture Multiple
- What is being tested?
- lidocaine, ketamine intravenous infusion and paravertebral block with ropivicaine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Jan 2025
- Phase
- Early Phase 1
- 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
- age 18-80 with rib fracture requiring hospitalization
- Failure of standard pain regimen as determined by RR > 20, TV < or equal to 50% predicted, NPS > or equal to 5, Poor cough
Who cannot join
- age less than 18 years
- greater than 80 years
- GCS less than or equal to 13
- intubated at admission
- prior or anticipated exploratory laparotomy during this admission
- prior or expected thoracotomy during this admission
Show all 12Show fewer
- prior or expected emergent craniotomy during this admission
- spinal cord injury
- pelvic injury that has required or will require operative intervention
- inability to accomplish activities of daily living independently
- pregnancy
- incarceration
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
Official title: Paravertebral Block Versus Simultaneous Ketamine and Lidocaine Infusions for Pain Management in Rib Fracture Patients
Rib fractures are a common admission to the trauma service. The mainstay of treatment is pain control to improve respiratory effort in order to offset the risk of pneumonia and mechanical ventilation. In addition to standard pain control modalities, the investigator's institution utilizes paravertebral blocks as well as lidocaine and ketamine infusions for pain control. The current standard of care for pain control is to begin with acetaminophen, ibuprofen or celecoxib and opioids with the addition of paravertebral blocks as needed. In certain situations, a paravertebral block is contraindicated, and pain control is relegated to lidocaine and ketamine infusion. The use of lidocaine infusion alone and ketamine infusion alone for pain control has been studied and has been shown to be safe. However, concurrent use of these two medications to control rib fracture pain is relatively new and the efficacy compared to paravertebral block is not known. The goal of the study is to show non-inferiority of simultaneous lidocaine and ketamine infusions versus paravertebral blocks.
Read the detailed description
Traumatic rib fractures are a common pathology in the trauma population. It is estimated that 10% of all trauma patients have rib fractures. The mainstay of treatment of rib fracture is pain control to allow for good pulmonary hygiene and function. When pain is not controlled, patients have a higher chance of developing pneumonia, which can lead to respiratory failure needing mechanical ventilation, eventually increasing patients' morbidity and mortality. These sequelae are most common in the elderly population. Multiple studies has shown that elderly patients with rib fractures have worse outcomes compared to younger patients with the same fracture pattern.
Pain control for acute rib fracture is achieved using multimodal analgesia to reduce the usage of opioids. Multimodal analgesia means using 2 or more drugs that act by different mechanism to provide pain control. The benefit of multimodal strategy is twofold; decrease the use of opioids and the associated side effects (eg. depressed respiratory drive, delirium, alteration of mental status) and better pain control. However, even with multimodal analgesia, pain control for acute traumatic rib fractures can be challenging. There are currently no validated management guidelines for traumatic rib fracture pain control and the approach varies by organization. At the investigator's institution, the investigators use a scheduled regimen of acetaminophen and NSAIDs, along with opioid medication as needed for pain. If this regimen is insufficient, other adjuncts such as paravertebral blocks (PVBs) and intravenous ketamine and lidocaine infusions are utilized. There are currently limited data on the combined use of ketamine and lidocaine infusions for traumatic rib fractures and it is unclear if the combination is non-inferior to PVBs in this patient population.
Continuous PVB infusion is a well-documented approach for pain control in traumatic rib fractures. But, there are occasionally prohibitive situations that contraindicate PVBs, such as vertebral fractures. Ketamine and lidocaine infusions are an attractive alternative in these situations, but the data regarding efficacy are lacking. Low dose ketamine infusion is a new addition to the pain control algorithm for trauma patients. Given that this is a novel approach, studies evaluating efficacy are sparse. There have been two randomized controlled trials utilizing low dose ketamine in trauma patients and elderly patients with rib fractures. Both were unable to show a decrease in opioid use; however, the authors were able to show a decrease in pain scores in patients with injury severity score (ISS) >15 in both studies. Another study of ketamine infusion in traumatic rib fracture patients admitted to the ICU showed an improvement in numeric pain scores (NPS) and decreased opioids requirements but, as in the previous studies, the ISS of these patients was very high (40) in both the ketamine and non-ketamine groups making generalization to the overall trauma population difficult.
Lidocaine has also been extensively studied as a local anesthetic and more recently has become popular as an infusion for systemic pain control. A recent review article compared 16 randomized control trials of lidocaine infusion on postoperative patients and showed that patients undergoing abdominal surgery had significant decreases in postoperative opioid consumption and improved pain scores. There has been some research into lidocaine infusions in burn patients showing that it can decrease opioid usage by 25%, but the cohort was small and there was no difference in reported pain scores. These data are intriguing but the applicability to trauma patients is questionable. Unfortunately, there has been no study to assess lidocaine infusions in patients with traumatic rib fractures. The investigators believe that there is a role for simultaneous lidocaine and ketamine infusions in traumatic rib fracture patients that may provide better pain control than each one used as a single infusion. The investigators propose a prospective, randomized open label clinical trial evaluating continuous infusion of ropivacaine via PVBs against simultaneous ketamine and lidocaine infusions. The instigators hypothesize that simultaneous lidocaine and ketamine infusions is non inferior to PVBs in traumatic rib fracture patients. The results of this study could help guide pain control strategies in this patient population.
- Conditions
- Rib Fractures, Rib Trauma, Rib Fracture Multiple, Pain, Acute
- Being tested
- lidocaine, ketamine intravenous infusion, paravertebral block with ropivicaine
- Medical subject headings
- Rib Fractures, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine, ketamine intravenous infusionCombination product
Patients will be started with our standard analgesia regiment which is standing oral acetaminophen 1000mg every 8 hours, ibuprofen 600mg every 6 hours or celecoxib 200mg every 12 hours, and narcotics as needed. All patients who failed the standard analgesia regimen will be approached for the study. Failure of standard analgesia regimen will be determined by respirations >20 minute, tidal volume ≤50% of predicted, numeric pain score ≥ 5, and a poor cough as determined by the trauma team.
Once the consent is obtained, the patients will be randomized to either PVB (control) or lidocaine/ketamine (study) groups. If the patient is randomized to lidocaine/ketamine group, the anesthesiologist led Acute Pain Service (APS) will prescribe lidocaine/ ketamine infusion, which will be monitored and titrated as necessary by APS. Standard analgesia will be continued on both study groups
paravertebral block with ropivicaineDrug
Patients will be started with our standard analgesia regiment which is standing oral acetaminophen 1000mg every 8 hours, ibuprofen 600mg every 6 hours or celecoxib 200mg every 12 hours, and narcotics as needed. All patients who failed the standard analgesia regimen will be approached for the study. Failure of standard analgesia regimen will be determined by respirations >20 minute, tidal volume ≤50% of predicted, numeric pain score ≥ 5, and a poor cough as determined by the trauma team.
Once the consent is obtained, the patients will be randomized to either PVB (control) or lidocaine/ketamine (study) groups. If the patient is randomized to PVB, the anesthesiologist led Acute Pain Service (APS) will place a paravertebral block catheter. Ropivacaine infusion will be started, monitored and titrated as necessary by APS. Standard analgesia will be continued on both study groups
| Study group | Role | What they receive |
|---|---|---|
| lidocaine/ ketamine infusion | Active comparator | Lidocaine/ ketamine infusion will be monitored and titrated as necessary by Anesthesiologist led Acute Pain Service. Receives: Combination Product: lidocaine, ketamine intravenous infusion |
| paravertebral block with ropivacaine | Active comparator | Paravertebral block catheter will be placed by Anesthesiology led Acute Pain Service. Once the catheter is inserted, a ropivacaine bolus and infused with ropivacaine, monitored and titrated as necessary by Anesthesiologist led Acute Pain Service. Receives: Drug: paravertebral block with ropivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Score (NPS)
Numeric pain score is a scale of 1- 10 to ascertain patient's subjective pain severity. Patients will be asked their NPS daily.
Measured: throughout patients' hospitalization time, an average of 1 week
Oral Morphine Equivalence (OME)
Oral morphine equivalence is used to standardized the amount of opioid patient is using regardless the type of opioid that the patient is prescribed.
Measured: throughout patients' hospitalization time, an average of 1 week
Secondary outcomes (6)
Hospital Length of Stay (LOS)
The hospital length of stay will be captured after patient is discharged from the hospital.
Measured: captured after patient is discharged, an average of 1 week
ICU Length of Stay (ICU LOS)
The ICU length of stay will be captured after patient is discharged from the hospital.
Measured: captured after patient is discharged, an average of 1 week
incidence of pneumonia
The diagnosis of pneumonia is captured when it is diagnosed by the primary team taking care of the patient.
Measured: throughout patients' hospitalization time, an average of 1 week
ventilator days
We will obtain the number of days patient is on the ventilator
Measured: throughout patients' hospitalization time, an average of 1 week
disposition upon discharge
Patient's disposition after discharge will be recorded. Disposition of patient will be recorded as home, long term acute facility, skilled nursing facility or acute rehab
Measured: captured after patient is discharged, an average of 1 week
in-hospital mortality
Patient's death will be recorded if it happen before discharge
Measured: captured after patient is discharged, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Sep 2020
- Primary completion31 Dec 2024
- Study completion1 Jan 2025
Why it stopped: not enough enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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 George Washington 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Kartiko, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413799
- Sponsor's protocol ID
- NRC1972020
- Status last verified
- Jun 2025
- First submitted
- 26 May 2020
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.
PubMed 7996614Bulger EM, Edwards T, Klotz P, Jurkovich GJ. Epidural analgesia improves outcome after multiple rib fractures. Surgery. 2004 Aug;136(2):426-30. doi: 10.1016/j.surg.2004.05.019.
PubMed 15300210Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7. doi: 10.1097/00005373-200006000-00007.
PubMed 10866248Holcomb JB, McMullin NR, Kozar RA, Lygas MH, Moore FA. Morbidity from rib fractures increases after age 45. J Am Coll Surg. 2003 Apr;196(4):549-55. doi: 10.1016/S1072-7515(02)01894-X.
PubMed 12691929Karmakar MK, Critchley LA, Ho AM, Gin T, Lee TW, Yim AP. Continuous thoracic paravertebral infusion of bupivacaine for pain management in patients with multiple fractured ribs. Chest. 2003 Feb;123(2):424-31. doi: 10.1378/chest.123.2.424.
PubMed 12576361Luyet C, Herrmann G, Ross S, Vogt A, Greif R, Moriggl B, Eichenberger U. Ultrasound-guided thoracic paravertebral puncture and placement of catheters in human cadavers: where do catheters go? Br J Anaesth. 2011 Feb;106(2):246-54. doi: 10.1093/bja/aeq309. Epub 2010 Nov 25.
PubMed 21112880Womack J, Pearson JD, Walker IA, Stephens NM, Goodman BA. Safety, complications and clinical outcome after ultrasound-guided paravertebral catheter insertion for rib fracture analgesia: a single-centre retrospective observational study. Anaesthesia. 2019 May;74(5):594-601. doi: 10.1111/anae.14580. Epub 2019 Jan 27.
PubMed 30687939Malekpour M, Hashmi A, Dove J, Torres D, Wild J. Analgesic Choice in Management of Rib Fractures: Paravertebral Block or Epidural Analgesia? Anesth Analg. 2017 Jun;124(6):1906-1911. doi: 10.1213/ANE.0000000000002113.
PubMed 28525509Carver TW, Kugler NW, Juul J, Peppard WJ, Drescher KM, Somberg LB, Szabo A, Yin Z, Paul JS. Ketamine infusion for pain control in adult patients with multiple rib fractures: Results of a randomized control trial. J Trauma Acute Care Surg. 2019 Feb;86(2):181-188. doi: 10.1097/TA.0000000000002103.
PubMed 30376537Kugler NW, Carver TW, Juul J, Peppard WJ, Boyle K, Drescher KM, Szabo A, Rein L, Somberg LB, Paul JS. Ketamine infusion for pain control in elderly patients with multiple rib fractures: Results of a randomized controlled trial. J Trauma Acute Care Surg. 2019 Nov;87(5):1181-1188. doi: 10.1097/TA.0000000000002479.
PubMed 31425468Walters MK, Farhat J, Bischoff J, Foss M, Evans C. Ketamine as an Analgesic Adjuvant in Adult Trauma Intensive Care Unit Patients With Rib Fracture. Ann Pharmacother. 2018 Sep;52(9):849-854. doi: 10.1177/1060028018768451. Epub 2018 Apr 2.
PubMed 29607659de Rocquigny G, Dubecq C, Martinez T, Peffer J, Cauet A, Travers S, Pasquier P. Use of ketamine for prehospital pain control on the battlefield: A systematic review. J Trauma Acute Care Surg. 2020 Jan;88(1):180-185. doi: 10.1097/TA.0000000000002522.
PubMed 31688832BARTLETT EE, HUTSERANI O. Xylocaine for the relief of postoperative pain. Anesth Analg. 1961 May-Jun;40:296-304. No abstract available.
PubMed 14448503Kim YC, Castaneda AM, Lee CS, Jin HS, Park KS, Moon JY. Efficacy and Safety of Lidocaine Infusion Treatment for Neuropathic Pain: A Randomized, Double-Blind, and Placebo-Controlled Study. Reg Anesth Pain Med. 2018 May;43(4):415-424. doi: 10.1097/AAP.0000000000000741.
PubMed 29381569McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.
PubMed 20518581
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Block Versus Simultaneous Ketamine and Lidocaine Infusions for Pain Management in Rib Fracture Patients
- ClinicalTrials.gov ID
- NCT04413799
- Acronym / sponsor ID
- NRC1972020
- Conditions
- Rib Fractures, Rib Trauma, Rib Fracture Multiple, Pain, Acute
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough enrollment
- Enrolment
- 32 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 4 Jun 2020 (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.
Rib fractures are a common admission to the trauma service. The mainstay of treatment is pain control to improve respiratory effort in order to offset the risk of pneumonia and mechanical ventilation. In addition to standard pain control modalities, the investigator's institution utilizes paravertebral blocks as well as lidocaine and ketamine infusions for pain control. The current standard of care for pain control is to begin with acetaminophen, ibuprofen or celecoxib and opioids with the addition of paravertebral blocks as needed. In certain situations, a paravertebral block is contraindicated, and pain control is relegated to lidocaine and ketamine infusion. The use of lidocaine infusion alone and ketamine infusion alone for pain control has been studied and has been shown to be safe. However, concurrent use of these two medications to control rib fracture pain is relatively new and the efficacy compared to paravertebral block is not known. The goal of the study is to show non-inferiority of simultaneous lidocaine and ketamine infusions versus paravertebral blocks.
Detailed description
Traumatic rib fractures are a common pathology in the trauma population. It is estimated that 10% of all trauma patients have rib fractures. The mainstay of treatment of rib fracture is pain control to allow for good pulmonary hygiene and function. When pain is not controlled, patients have a higher chance of developing pneumonia, which can lead to respiratory failure needing mechanical ventilation, eventually increasing patients' morbidity and mortality. These sequelae are most common in the elderly population. Multiple studies has shown that elderly patients with rib fractures have worse outcomes compared to younger patients with the same fracture pattern.
Pain control for acute rib fracture is achieved using multimodal analgesia to reduce the usage of opioids. Multimodal analgesia means using 2 or more drugs that act by different mechanism to provide pain control. The benefit of multimodal strategy is twofold; decrease the use of opioids and the associated side effects (eg. depressed respiratory drive, delirium, alteration of mental status) and better pain control. However, even with multimodal analgesia, pain control for acute traumatic rib fractures can be challenging. There are currently no validated management guidelines for traumatic rib fracture pain control and the approach varies by organization. At the investigator's institution, the investigators use a scheduled regimen of acetaminophen and NSAIDs, along with opioid medication as needed for pain. If this regimen is insufficient, other adjuncts such as paravertebral blocks (PVBs) and intravenous ketamine and lidocaine infusions are utilized. There are currently limited data on the combined use of ketamine and lidocaine infusions for traumatic rib fractures and it is unclear if the combination is non-inferior to PVBs in this patient population.
Continuous PVB infusion is a well-documented approach for pain control in traumatic rib fractures. But, there are occasionally prohibitive situations that contraindicate PVBs, such as vertebral fractures. Ketamine and lidocaine infusions are an attractive alternative in these situations, but the data regarding efficacy are lacking. Low dose ketamine infusion is a new addition to the pain control algorithm for trauma patients. Given that this is a novel approach, studies evaluating efficacy are sparse. There have been two randomized controlled trials utilizing low dose ketamine in trauma patients and elderly patients with rib fractures. Both were unable to show a decrease in opioid use; however, the authors were able to show a decrease in pain scores in patients with injury severity score (ISS) >15 in both studies. Another study of ketamine infusion in traumatic rib fracture patients admitted to the ICU showed an improvement in numeric pain scores (NPS) and decreased opioids requirements but, as in the previous studies, the ISS of these patients was very high (40) in both the ketamine and non-ketamine groups making generalization to the overall trauma population difficult.
Lidocaine has also been extensively studied as a local anesthetic and more recently has become popular as an infusion for systemic pain control. A recent review article compared 16 randomized control trials of lidocaine infusion on postoperative patients and showed that patients undergoing abdominal surgery had significant decreases in postoperative opioid consumption and improved pain scores. There has been some research into lidocaine infusions in burn patients showing that it can decrease opioid usage by 25%, but the cohort was small and there was no difference in reported pain scores. These data are intriguing but the applicability to trauma patients is questionable. Unfortunately, there has been no study to assess lidocaine infusions in patients with traumatic rib fractures. The investigators believe that there is a role for simultaneous lidocaine and ketamine infusions in traumatic rib fracture patients that may provide better pain control than each one used as a single infusion. The investigators propose a prospective, randomized open label clinical trial evaluating continuous infusion of ropivacaine via PVBs against simultaneous ketamine and lidocaine infusions. The instigators hypothesize that simultaneous lidocaine and ketamine infusions is non inferior to PVBs in traumatic rib fracture patients. The results of this study could help guide pain control strategies in this patient population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine/ ketamine infusion | Active comparator | Combination Product: lidocaine, ketamine intravenous infusionLidocaine/ ketamine infusion will be monitored and titrated as necessary by Anesthesiologist led Acute Pain Service. |
| paravertebral block with ropivacaine | Active comparator | Drug: paravertebral block with ropivicaineParavertebral block catheter will be placed by Anesthesiology led Acute Pain Service. Once the catheter is inserted, a ropivacaine bolus and infused with ropivacaine, monitored and titrated as necessary by Anesthesiologist led Acute Pain Service. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-80 with rib fracture requiring hospitalization
- Failure of standard pain regimen as determined by RR > 20, TV < or equal to 50% predicted, NPS > or equal to 5, Poor cough
Key exclusion criteria (12 listed)
- age less than 18 years
- greater than 80 years
- GCS less than or equal to 13
- intubated at admission
- prior or anticipated exploratory laparotomy during this admission
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, ketamine intravenous infusionPatients will be started with our standard analgesia regiment which is standing oral acetaminophen 1000mg every 8 hours, ibuprofen 600mg every 6 hours or celecoxib 200mg every 12 hours, and narcotics as needed. All patients who failed the standard analgesia regimen will be approached for the study. Failure of standard analgesia regimen will be determined by respirations >20 minute, tidal volume ≤50% of predicted, numeric pain score ≥ 5, and a poor cough as determined by the trauma team. Once the consent is obtained, the patients will be randomized to either PVB (control) or lidocaine/ketamine (study) groups. If the patient is randomized to lidocaine/ketamine group, the anesthesiologist led Acute Pain Service (APS) will prescribe lidocaine/ ketamine infusion, which will be monitored and titrated as necessary by APS. Standard analgesia will be continued on both study groups | Combination product | lidocaine/ ketamine infusion |
| paravertebral block with ropivicainePatients will be started with our standard analgesia regiment which is standing oral acetaminophen 1000mg every 8 hours, ibuprofen 600mg every 6 hours or celecoxib 200mg every 12 hours, and narcotics as needed. All patients who failed the standard analgesia regimen will be approached for the study. Failure of standard analgesia regimen will be determined by respirations >20 minute, tidal volume ≤50% of predicted, numeric pain score ≥ 5, and a poor cough as determined by the trauma team. Once the consent is obtained, the patients will be randomized to either PVB (control) or lidocaine/ketamine (study) groups. If the patient is randomized to PVB, the anesthesiologist led Acute Pain Service (APS) will place a paravertebral block catheter. Ropivacaine infusion will be started, monitored and titrated as necessary by APS. Standard analgesia will be continued on both study groups | Drug | paravertebral block with ropivacaine |
Primary outcome
Numeric Pain Score (NPS)
Time frame: throughout patients' hospitalization time, an average of 1 week
Numeric pain score is a scale of 1- 10 to ascertain patient's subjective pain severity. Patients will be asked their NPS daily.
Oral Morphine Equivalence (OME)
Time frame: throughout patients' hospitalization time, an average of 1 week
Oral morphine equivalence is used to standardized the amount of opioid patient is using regardless the type of opioid that the patient is prescribed.
6 secondary outcomes
Hospital Length of Stay (LOS)
Time frame: captured after patient is discharged, an average of 1 week
ICU Length of Stay (ICU LOS)
Time frame: captured after patient is discharged, an average of 1 week
incidence of pneumonia
Time frame: throughout patients' hospitalization time, an average of 1 week
ventilator days
Time frame: throughout patients' hospitalization time, an average of 1 week
disposition upon discharge
Time frame: captured after patient is discharged, an average of 1 week
in-hospital mortality
Time frame: captured after patient is discharged, an average of 1 week
Results and safety
The study was stopped early (reason given: not enough enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Background: PubMed 7996614Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.
- Background: PubMed 15300210Bulger EM, Edwards T, Klotz P, Jurkovich GJ. Epidural analgesia improves outcome after multiple rib fractures. Surgery. 2004 Aug;136(2):426-30. doi: 10.1016/j.surg.2004.05.019.
- Background: PubMed 10866248Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7. doi: 10.1097/00005373-200006000-00007.
- Background: PubMed 12691929Holcomb JB, McMullin NR, Kozar RA, Lygas MH, Moore FA. Morbidity from rib fractures increases after age 45. J Am Coll Surg. 2003 Apr;196(4):549-55. doi: 10.1016/S1072-7515(02)01894-X.
- Background: PubMed 12576361Karmakar MK, Critchley LA, Ho AM, Gin T, Lee TW, Yim AP. Continuous thoracic paravertebral infusion of bupivacaine for pain management in patients with multiple fractured ribs. Chest. 2003 Feb;123(2):424-31. doi: 10.1378/chest.123.2.424.
- Background: PubMed 21112880Luyet C, Herrmann G, Ross S, Vogt A, Greif R, Moriggl B, Eichenberger U. Ultrasound-guided thoracic paravertebral puncture and placement of catheters in human cadavers: where do catheters go? Br J Anaesth. 2011 Feb;106(2):246-54. doi: 10.1093/bja/aeq309. Epub 2010 Nov 25.
- Background: PubMed 30687939Womack J, Pearson JD, Walker IA, Stephens NM, Goodman BA. Safety, complications and clinical outcome after ultrasound-guided paravertebral catheter insertion for rib fracture analgesia: a single-centre retrospective observational study. Anaesthesia. 2019 May;74(5):594-601. doi: 10.1111/anae.14580. Epub 2019 Jan 27.
- Background: PubMed 28525509Malekpour M, Hashmi A, Dove J, Torres D, Wild J. Analgesic Choice in Management of Rib Fractures: Paravertebral Block or Epidural Analgesia? Anesth Analg. 2017 Jun;124(6):1906-1911. doi: 10.1213/ANE.0000000000002113.
- Background: PubMed 30376537Carver TW, Kugler NW, Juul J, Peppard WJ, Drescher KM, Somberg LB, Szabo A, Yin Z, Paul JS. Ketamine infusion for pain control in adult patients with multiple rib fractures: Results of a randomized control trial. J Trauma Acute Care Surg. 2019 Feb;86(2):181-188. doi: 10.1097/TA.0000000000002103.
- Background: PubMed 31425468Kugler NW, Carver TW, Juul J, Peppard WJ, Boyle K, Drescher KM, Szabo A, Rein L, Somberg LB, Paul JS. Ketamine infusion for pain control in elderly patients with multiple rib fractures: Results of a randomized controlled trial. J Trauma Acute Care Surg. 2019 Nov;87(5):1181-1188. doi: 10.1097/TA.0000000000002479.
- Background: PubMed 29607659Walters MK, Farhat J, Bischoff J, Foss M, Evans C. Ketamine as an Analgesic Adjuvant in Adult Trauma Intensive Care Unit Patients With Rib Fracture. Ann Pharmacother. 2018 Sep;52(9):849-854. doi: 10.1177/1060028018768451. Epub 2018 Apr 2.
- Background: PubMed 31688832de Rocquigny G, Dubecq C, Martinez T, Peffer J, Cauet A, Travers S, Pasquier P. Use of ketamine for prehospital pain control on the battlefield: A systematic review. J Trauma Acute Care Surg. 2020 Jan;88(1):180-185. doi: 10.1097/TA.0000000000002522.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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
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 Early Phase 1 study testing lidocaine, ketamine intravenous infusion and paravertebral block with ropivicaine in people with Rib Fractures and Rib Trauma, run by George Washington 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 12 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 22 Jun 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 stopped early (reason given: not enough enrollment). Results are not available in the source record.
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?
Numeric Pain Score (NPS) (time frame: throughout patients' hospitalization time, an average of 1 week). 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?
On the ClinicalTrials.gov record for NCT04413799, which also lists 16 linked publications.
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 22 Jun 2025.