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

Phase 2

Not yet recruiting

• Conditions: Rib Fractures
• Interventions: Drug: 2% Lidocaine via ESPB; Drug: Lidocaine IV Infusion

• Registration Number: NCT04707183
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-18
• Study Start: 2024-03
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	2% Lidocaine via ESPB	10 mL of 2% lidocaine via ESPB
Control Arm	Lidocaine IV Infusion	1.0mg/kg/hr IV lidocaine infusion

Primary Outcome Measures

Name	Time	Method
OME consumption at 24 hours of treatment.	Up to 24 hours of treatment	Oral morphine equivalent consumption at 24 hours of treatment

Secondary Outcome Measures

Name	Time	Method
OME at 48 hrs	Up to 48 hours of treatment	Oral morphine equivalent consumption at 48 hours of treatment
Pain Score	Every 4 hours general pain scores, and baseline, 24 hours, 48 hour, 72 hours for pain scores with cough and inspiration.	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
Incentive spirometry volumes (volume of 0 - 5000 mL)	Time 0, 24 hours, 48 hour, and 72 hours	An incentive spirometer is a device that measures how deeply you can inhale. Higher volumes indicate greater ability to inhale.
PIC score	Time 0, 24 hours, 48 hour, and 72 hours.	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
Length of hospital stay	Up to 10 days	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+)
Inflammatory biomarkers	Time 0, 24 hours, and 48 hour	Will be looking at proinflammatory markers (IL6, IL8, IL-1β, TNF-α) and f anti-inflammatory markers (IL10)
Rates of pulmonary complications	Will be assessed up to 72 hours	We will look at the occurrence of complications such as ARDS, pneumonia, aspiration, empyema, including need for positive pressure ventilation, pneumonia, aspiration, supplemental oxygen

Trial Locations

Locations (1)

Stanford Health Care; 🇺🇸 Stanford, California, United States