Clinical trial NCT04707183: Comparison of Continuous Intravenous Lidocaine Infusion Versus ESP Block for Rib Fracture Analgesia
Official title: Comparison of Continuous Intravenous Lidocaine Infusion Versus ESP Block for Rib Fracture Analgesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Rib Fractures
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: OME consumption at 24 hours of treatment.
timeFrame: Up to 24 hours of treatment
Secondary outcomes:
measure: OME at 48 hrs
timeFrame: Up to 48 hours of treatment
measure: Pain Score
timeFrame: Every 4 hours general pain scores, and baseline, 24 hours, 48 hour, 72 hours for pain scores with cough and inspiration.
measure: Incentive spirometry volumes (volume of 0 - 5000 mL)
timeFrame: Time 0, 24 hours, 48 hour, and 72 hours
measure: PIC score
timeFrame: Time 0, 24 hours, 48 hour, and 72 hours.
measure: Length of hospital stay
timeFrame: Up to 10 days
measure: Inflammatory biomarkers
timeFrame: Time 0, 24 hours, and 48 hour
measure: Rates of pulmonary complications
timeFrame: Will be assessed up to 72 hours
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
References:
citation: 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.