Comparison of Continuous Intravenous Lidocaine Infusion Versus ESP Block for Rib Fracture Analgesia

Rib Fractures Clinical Trial

— Rib Fract ESP  

Official title:

Comparison of Continuous Intravenous Lidocaine Infusion Versus ESP Block for Rib Fracture Analgesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04707183
• Other study ID #: 53844
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: Ban Tsui, MD
• Phone: (650) 200-9107
• Email: bantsui[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All adult patients admitted to Stanford Health Care with two or more acute traumatic rib fractures.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

Intervention

Drug:
• Lidocaine IV Infusion
Lidocaine will infused through erector spinae plane block catheter in patients with traumatic rib fracture.
• 2% Lidocaine via ESPB
10 ml of 2% lidocaine will be infused through ESPB in treatment group

Locations

Country	Name	City	State
United States	Stanford Health Care	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OME consumption at 24 hours of treatment.	Oral morphine equivalent consumption at 24 hours of treatment	Up to 24 hours of treatment
Secondary	OME at 48 hrs	Oral morphine equivalent consumption at 48 hours of treatment	Up to 48 hours of treatment
Secondary	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	Every 4 hours general pain scores, and baseline, 24 hours, 48 hour, 72 hours for pain scores with cough and inspiration.
Secondary	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.	Time 0, 24 hours, 48 hour, and 72 hours
Secondary	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	Time 0, 24 hours, 48 hour, and 72 hours.
Secondary	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+)	Up to 10 days
Secondary	Inflammatory biomarkers	Will be looking at proinflammatory markers (IL6, IL8, IL-1ß, TNF-a) and f anti-inflammatory markers (IL10)	Time 0, 24 hours, and 48 hour
Secondary	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	Will be assessed up to 72 hours

External Links

•   Aggarwal A. A Role for Peripheral Intravenous Lidocaine Infusion for Rib Fracture Pain Management. Poster presented at: ASRA 16th Annual Pain Medicine Meeting of the Society of Regional Anesthesia and Pain Medicine; Nov 16-18, 2017; Lake Buena Vista, FL.