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

Studies

Study First Submitted Date 2020-12-23
Study First Posted Date 2021-01-13
Last Update Posted Date 2023-04-18
Start Month Year March 2024
Primary Completion Month Year December 2024
Verification Month Year April 2023
Verification Date 2023-04-30
Last Update Posted Date 2023-04-18

Facilities

Sequence: 200327238
Name Stanford Health Care
City Stanford
State California
Zip 94305
Country United States

Facility Contacts

Sequence: 28138836
Facility Id 200327238
Contact Type primary
Name Ban Tsui, MD
Email bantsui@stanford.edu
Phone 650-200-9107

Browse Interventions

Sequence: 96157990 Sequence: 96157991 Sequence: 96157992 Sequence: 96157993 Sequence: 96157994 Sequence: 96157995 Sequence: 96157996 Sequence: 96157997 Sequence: 96157998 Sequence: 96157999 Sequence: 96158000 Sequence: 96158001
Mesh Term Lidocaine Mesh Term Anesthetics, Local Mesh Term Anesthetics Mesh Term Central Nervous System Depressants Mesh Term Physiological Effects of Drugs Mesh Term Sensory System Agents Mesh Term Peripheral Nervous System Agents Mesh Term Anti-Arrhythmia Agents Mesh Term Voltage-Gated Sodium Channel Blockers Mesh Term Sodium Channel Blockers Mesh Term Membrane Transport Modulators Mesh Term Molecular Mechanisms of Pharmacological Action
Downcase Mesh Term lidocaine Downcase Mesh Term anesthetics, local Downcase Mesh Term anesthetics Downcase Mesh Term central nervous system depressants Downcase Mesh Term physiological effects of drugs Downcase Mesh Term sensory system agents Downcase Mesh Term peripheral nervous system agents Downcase Mesh Term anti-arrhythmia agents Downcase Mesh Term voltage-gated sodium channel blockers Downcase Mesh Term sodium channel blockers Downcase Mesh Term membrane transport modulators Downcase Mesh Term molecular mechanisms of pharmacological action
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52237609
Name Rib Fractures
Downcase Name rib fractures

Id Information

Sequence: 40207129
Id Source org_study_id
Id Value 53844

Countries

Sequence: 42621527
Name United States
Removed False

Design Groups

Sequence: 55668004 Sequence: 55668005
Group Type Placebo Comparator Group Type Experimental
Title Control Arm Title Treatment Arm
Description 1.0mg/kg/hr IV lidocaine infusion Description 10 mL of 2% lidocaine via ESPB

Interventions

Sequence: 52551243 Sequence: 52551242
Intervention Type Drug Intervention Type Drug
Name 2% Lidocaine via ESPB Name Lidocaine IV Infusion
Description 10 ml of 2% lidocaine will be infused through ESPB in treatment group Description Lidocaine will infused through erector spinae plane block catheter in patients with traumatic rib fracture.

Design Outcomes

Sequence: 177621846 Sequence: 177621847 Sequence: 177621848 Sequence: 177621849 Sequence: 177621850 Sequence: 177621851 Sequence: 177621852 Sequence: 177621853
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure OME consumption at 24 hours of treatment. Measure OME at 48 hrs Measure Pain Score Measure Incentive spirometry volumes (volume of 0 – 5000 mL) Measure PIC score Measure Length of hospital stay Measure Inflammatory biomarkers Measure Rates of pulmonary complications
Time Frame Up to 24 hours of treatment Time Frame Up to 48 hours of treatment Time Frame Every 4 hours general pain scores, and baseline, 24 hours, 48 hour, 72 hours for pain scores with cough and inspiration. Time Frame Time 0, 24 hours, 48 hour, and 72 hours Time Frame Time 0, 24 hours, 48 hour, and 72 hours. Time Frame Up to 10 days Time Frame Time 0, 24 hours, and 48 hour Time Frame Will be assessed up to 72 hours
Description Oral morphine equivalent consumption at 24 hours of treatment Description Oral morphine equivalent consumption at 48 hours of treatment Description 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 Description An incentive spirometer is a device that measures how deeply you can inhale. Higher volumes indicate greater ability to inhale. Description 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 Description 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+) Description Will be looking at proinflammatory markers (IL6, IL8, IL-1β, TNF-α) and f anti-inflammatory markers (IL10) Description We will look at the occurrence of complications such as ARDS, pneumonia, aspiration, empyema, including need for positive pressure ventilation, pneumonia, aspiration, supplemental oxygen

Browse Conditions

Sequence: 193739495 Sequence: 193739496 Sequence: 193739497 Sequence: 193739498
Mesh Term Fractures, Bone Mesh Term Rib Fractures Mesh Term Wounds and Injuries Mesh Term Thoracic Injuries
Downcase Mesh Term fractures, bone Downcase Mesh Term rib fractures Downcase Mesh Term wounds and injuries Downcase Mesh Term thoracic injuries
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48381677
Agency Class OTHER
Lead Or Collaborator lead
Name Stanford University

Central Contacts

Sequence: 12024225 Sequence: 12024226
Contact Type primary Contact Type backup
Name Ban Tsui, MD Name Chynna Villanueva, BS, RN
Phone (650) 200-9107
Email bantsui@stanford.edu Email chynnav@stanford.edu
Role Contact Role Contact

Design Group Interventions

Sequence: 68239283 Sequence: 68239284
Design Group Id 55668004 Design Group Id 55668005
Intervention Id 52551242 Intervention Id 52551243

Eligibilities

Sequence: 30804204
Gender All
Minimum Age 18 Years
Maximum Age 80 Years
Healthy Volunteers No
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.
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254022244
Number Of Facilities 1
Registered In Calendar Year 2020
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 80
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 7

Designs

Sequence: 30550214
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Subject Masked True

Intervention Other Names

Sequence: 26703422
Intervention Id 52551242
Name Lidocaine

Links

Sequence: 4393315
Url http://epostersonline.com/ASRAFALL17/node/108
Description 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.

Responsible Parties

Sequence: 28916565
Responsible Party Type Principal Investigator
Name Chi-Ho Ban Tsui
Title Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University
Affiliation Stanford University

Study References

Sequence: 52136502
Pmid 10969322
Reference Type background
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.