Clinical trial

Paravertebral Block Versus Simultaneous Ketamine and Lidocaine Infusions for Pain Management in Rib Fracture Patients

Name

NRC1972020

Description

Rib fractures are a common admission to the trauma service. The mainstay of treatment is pain control to improve respiratory effort in order to offset the risk of pneumonia and mechanical ventilation. In addition to standard pain control modalities, the investigator's institution utilizes paravertebral blocks as well as lidocaine and ketamine infusions for pain control. The current standard of care for pain control is to begin with acetaminophen, ibuprofen or celecoxib and opioids with the addition of paravertebral blocks as needed. In certain situations, a paravertebral block is contraindicated, and pain control is relegated to lidocaine and ketamine infusion. The use of lidocaine infusion alone and ketamine infusion alone for pain control has been studied and has been shown to be safe. However, concurrent use of these two medications to control rib fracture pain is relatively new and the efficacy compared to paravertebral block is not known. The goal of the study is to show non-inferiority of simultaneous lidocaine and ketamine infusions versus paravertebral blocks.

Trial arms

Trial start

2020-09-01

Estimated PCD

2024-12-31

Trial end

2025-05-30

Status

Recruiting

Phase

Early phase I

Treatment

lidocaine, ketamine intravenous infusion

Patients will be started with our standard analgesia regiment which is standing oral acetaminophen 1000mg every 8 hours, ibuprofen 600mg every 6 hours or celecoxib 200mg every 12 hours, and narcotics as needed. All patients who failed the standard analgesia regimen will be approached for the study. Failure of standard analgesia regimen will be determined by respirations \>20 minute, tidal volume ≤50% of predicted, numeric pain score ≥ 5, and a poor cough as determined by the trauma team. Once the consent is obtained, the patients will be randomized to either PVB (control) or lidocaine/ketamine (study) groups. If the patient is randomized to lidocaine/ketamine group, the anesthesiologist led Acute Pain Service (APS) will prescribe lidocaine/ ketamine infusion, which will be monitored and titrated as necessary by APS. Standard analgesia will be continued on both study groups

Arms:

lidocaine/ ketamine infusion

paravertebral block with ropivicaine

Patients will be started with our standard analgesia regiment which is standing oral acetaminophen 1000mg every 8 hours, ibuprofen 600mg every 6 hours or celecoxib 200mg every 12 hours, and narcotics as needed. All patients who failed the standard analgesia regimen will be approached for the study. Failure of standard analgesia regimen will be determined by respirations \>20 minute, tidal volume ≤50% of predicted, numeric pain score ≥ 5, and a poor cough as determined by the trauma team. Once the consent is obtained, the patients will be randomized to either PVB (control) or lidocaine/ketamine (study) groups. If the patient is randomized to PVB, the anesthesiologist led Acute Pain Service (APS) will place a paravertebral block catheter. Ropivacaine infusion will be started, monitored and titrated as necessary by APS. Standard analgesia will be continued on both study groups

Arms:

paravertebral block with ropivacaine

Size

170

Primary endpoint

Numeric Pain Score (NPS)

throughout patients' hospitalization time, an average of 1 week

Oral Morphine Equivalence (OME)

throughout patients' hospitalization time, an average of 1 week

Eligibility criteria

Inclusion Criteria: * age 18-80 with rib fracture requiring hospitalization * Failure of standard pain regimen as determined by RR \> 20, TV \< or equal to 50% predicted, NPS \> or equal to 5, Poor cough Exclusion Criteria: * age less than 18 years * greater than 80 years * GCS less than or equal to 13 * intubated at admission * prior or anticipated exploratory laparotomy during this admission * prior or expected thoracotomy during this admission * prior or expected emergent craniotomy during this admission * spinal cord injury * pelvic injury that has required or will require operative intervention * inability to accomplish activities of daily living independently * pregnancy * incarceration

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 170, 'type': 'ESTIMATED'}}

Updated at

2024-01-08

1 organization

2 products

5 indications

Organization

George Washington University

Product

Lidocaine

Indication

Rib Fractures

Indication