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

NCT ID: NCT04707183

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Arm

1.0mg/kg/hr IV lidocaine infusion

Group Type: PLACEBO_COMPARATOR

Lidocaine IV Infusion

Intervention Type: DRUG

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

Treatment Arm

10 mL of 2% lidocaine via ESPB

Group Type: EXPERIMENTAL

2% Lidocaine via ESPB

Intervention Type: DRUG

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

Interventions

Lidocaine IV Infusion

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

Intervention Type: DRUG

2% Lidocaine via ESPB

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

Intervention Type: DRUG

Other Intervention Names

Lidocaine

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Chi-Ho Ban Tsui

Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford Health Care

Stanford, California, United States

Countries

United States

Central Contacts

Ban Tsui, MD

Role: CONTACT

bantsui@stanford.edu

(650) 200-9107

Chynna Villanueva, BS, RN

Role: CONTACT

chynnav@stanford.edu

Facility Contacts

Ban Tsui, MD

Role: primary

bantsui@stanford.edu

650-200-9107

References

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.

Reference Type: BACKGROUND

PMID: 10969322 (View on PubMed)

Related Links

http://epostersonline.com/ASRAFALL17/node/108

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.

Other Identifiers

53844

Identifier Type: -

Identifier Source: org_study_id