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

NCT04707183 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 53844
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (1)

• OME consumption at 24 hours of treatment.

  Oral morphine equivalent consumption at 24 hours of treatment

  Up to 24 hours of treatment

Secondary Outcomes (7)

• OME at 48 hrs

  Up to 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.

• Incentive spirometry volumes (volume of 0 - 5000 mL)

  Time 0, 24 hours, 48 hour, and 72 hours

• PIC score

  Time 0, 24 hours, 48 hour, and 72 hours.

• Length of hospital stay

  Up to 10 days

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

1.0mg/kg/hr IV lidocaine infusion

Drug: Lidocaine IV Infusion

Treatment Arm

EXPERIMENTAL

10 mL of 2% lidocaine via ESPB

Drug: 2% Lidocaine via ESPB

Interventions

Lidocaine IV Infusion DRUG

Lidocaine will infused through erector spinae plane block catheter in patients with traumatic rib fracture.

Also known as: Lidocaine

Control Arm

2% Lidocaine via ESPB DRUG

10 ml of 2% lidocaine will be infused through ESPB in treatment group

Treatment Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

Related 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.

  PMID: 10969322 BACKGROUND

MeSH Terms

Conditions

Rib Fractures

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor in Anesthesiology

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 13, 2021
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-04

Locations

US (1)