PVB vs Ketamine/Lidocaine in Rib Fracture Patients

NCT04413799 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: NRC1972020
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Rib Fractures; Rib Trauma; Rib Fracture Multiple; Pain, Acute

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  throughout patients' hospitalization time, an average of 1 week

Secondary Outcomes (6)

• Hospital Length of Stay (LOS)

  captured after patient is discharged, an average of 1 week

• ICU Length of Stay (ICU LOS)

  captured after patient is discharged, an average of 1 week

• incidence of pneumonia

  throughout patients' hospitalization time, an average of 1 week

• ventilator days

  throughout patients' hospitalization time, an average of 1 week

• disposition upon discharge

  captured after patient is discharged, an average of 1 week

Study Arms (2)

lidocaine/ ketamine infusion

ACTIVE COMPARATOR

Lidocaine/ ketamine infusion will be monitored and titrated as necessary by Anesthesiologist led Acute Pain Service.

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.

Drug: paravertebral block with ropivicaine

Interventions

lidocaine, ketamine intravenous infusion COMBINATION_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

lidocaine/ ketamine infusion

paravertebral block with ropivicaine DRUG

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

paravertebral block with ropivacaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

The George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (16)

• 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.

  PMID: 7996614 BACKGROUND

• Bulger 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.

  PMID: 15300210 BACKGROUND

• Bulger 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.

  PMID: 10866248 BACKGROUND

• Holcomb 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.

  PMID: 12691929 BACKGROUND

• Karmakar 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.

  PMID: 12576361 BACKGROUND

• Luyet 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.

  PMID: 21112880 BACKGROUND

• Womack 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.

  PMID: 30687939 BACKGROUND

• Malekpour 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.

  PMID: 28525509 BACKGROUND

• Carver 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.

  PMID: 30376537 BACKGROUND

• Kugler 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.

  PMID: 31425468 BACKGROUND

• Walters 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.

  PMID: 29607659 BACKGROUND

• de 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.

  PMID: 31688832 BACKGROUND

• BARTLETT EE, HUTSERANI O. Xylocaine for the relief of postoperative pain. Anesth Analg. 1961 May-Jun;40:296-304. No abstract available.

  PMID: 14448503 BACKGROUND

• Kim 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.

  PMID: 29381569 BACKGROUND

• McCarthy 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.

  PMID: 20518581 BACKGROUND

• Abdelrahman I, Steinvall I, Elmasry M, Sjoberg F. Lidocaine infusion has a 25% opioid-sparing effect on background pain after burns: A prospective, randomised, double-blind, controlled trial. Burns. 2020 Mar;46(2):465-471. doi: 10.1016/j.burns.2019.08.010. Epub 2019 Sep 5.

  PMID: 31493952 BACKGROUND

MeSH Terms

Conditions

Rib Fractures; Acute Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 4, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)