Pain, Acute, Trauma, Trauma Injury
Conditions
Keywords
Rib trauma, intercostal nerve block, liposomal bupivacaine
Brief summary
Management of traumatic rib fractures continues to be a challenge for trauma surgeons. Currently, many analgesic options are available to patients suffering from rib fractures. Formulations currently used for conventional intercostal nerve blocks (CINB) are relatively safe, do not require additional equipment or specialized anesthesia personnel, do not require catheter repositioning, and provide improved analgesia immediately over the aforementioned systemic therapies. A goal of these authors to introduce an additional safe option for extended local analgesia in the setting of multiple rib fractures given the inconclusive evidence supporting or refuting the current standard of care
Detailed description
The objective of this study is to quantify and draw inferences on the efficacy of a multiple level liposomal bupivacaine intercostal nerve blockade (LBINB) in patients with multiple traumatic rib fractures. The primary objective is to assess the quality and duration of analgesia based on numeric grading pain scale, improvement in pulmonary function parameters, reduction pulmonary complications, and duration of hospitalization in patients receiving LBINBs relative to those receiving the current standard of care, CEA, in patients recovering from multiple traumatic rib fractures. The secondary objective of this study is to assess cost and rate of complications associated with LBINB relative to CEA. This is a two arm, randomized trial. Patients suffering multiple traumatic rib fractures will be offered CEA or LBINB. As the current standard of care, CEA will serve as the control, and outcomes measured in patients receiving LBINB will be statistically evaluated relative to the CEA control group. All patients will receive standardized NSAID and opioid analgesia protocol for break through pain, as well as standardized routines for pulmonary hygiene and physiotherapy. Indications for CEA and LBINB in this study include patients suffering from traumatic thoracic injury with greater than or equal to 3 fractured ribs
Interventions
Under ultrasound guidance, corresponding ribs will be identified. 3-5 ml of a 1.3% (13.3 mg/mL) of liposomal bupivacaine will be drawn into a syringe with a 1.5-in, 22-gauge needle. The needle will then be advanced 20° cephalad to the skin 3-4 cm lateral to midline at the level of each fractured rib, and 1-2 ribs levels above and below injury. The needle will be advanced 3 mm below the inferior margin of the rib, placing the tip in the space containing the neurovascular bundle. Following negative aspiration for blood or air, 3-5 mL of local anesthetic will be infused and the needle withdrawn. No more than 266 mg, or 20 ml, of the 1.3% (13.3 mg/mL) liposomal bupivacaine solution will be injected
DRUGBupivacaine
The anesthesia department will manage CEA. If possible, the patient will be in the sitting position. The skin will be prepped with chlorhexidine and sterilely draped. 3 mL of lidocaine 1% will be infiltrated the closest interspace to the rib fractures between T4 -T12. A Touhy needle will be inserted, the epidural space identified by loss of resistance technique. An epidural catheter will then be inserted to a depth of 12cm. 3 mL of test solution with lidocaine 1.5% with epinephrine, 1:200,000 will be injected with continuous EKG and SpO2 monitoring. Delivery of a 0.125% bupivacaine solution be continuously infused and titrated based on the patient's clinical status
Sponsors
University of Illinois College of Medicine at Peoria
OSF Healthcare System
Chadrick Evans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No participants are blinded to treatment arms. Patients and investigators are aware of which patients are assigned to each treatment group.
Intervention model description
This is a two arm, randomized trial. Patients suffering multiple traumatic rib fractures will be offered CEA or LBINB. As the current standard of care, CEA will serve as the control, and outcomes measured in patients receiving LBINB will be statistically evaluated relative to the CEA control group. All patients will receive standardized NSAID and opioid analgesia protocol for break through pain, as well as standardized routines for pulmonary hygiene and physiotherapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients 18 years of age or older suffering 3 or more rib fractures treated by University of Illinois College of Medicine at Peoria (UICOMP) attending or resident physicians at OSF St. Francis Medical Center (OSFMC) are potentially eligible for enrollment in the trial.
Exclusion criteria
* Patients with any of the following will not be eligible since they are contraindications to CEA, LBINB, or both: 1. Intracranial hemorrhage 2. Fever >101 degrees Fahrenheit for ≥ 1 hour(s) 3. Rash at site of catheter insertion or administration of nerve block 4. Hemodynamic instability 5. Spinal cord injury 6. Vertebral fractures 7. Allergy to bupivacaine 8. Systemic therapeutic anticoagulation required for duration of hospital admission 20 9. Altered mental status without medical decision maker to provide consent 10. Patients without the capacity to consent or the lack of a medical decision maker to consent 11. Patients that are pregnant 12. Legally confined patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain relief | 96 hours | Quality of analgesia provided measured by numeric grading pain scale assessment every 24 hours over a 96-hour period. Pain will be rated using the Numerical Rating Scale, ranging from 0-10. Zero represents no pain; worsening pain signified by increasing reported numbers with 10 being the upper limit and the worst pain possible. Only the numbers can be answers, meaning that there are only 11 possible answers on the 0-10 scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of pain medication | every 24hours for 96hours | Duration of analgesia provided measured by numeric grading pain scale assessment every 24hours. Quality of analgesia provided measured by numeric grading pain scale assessment every 24 hours over a 96-hour period. Pain will be rated using the Numerical Rating Scale, ranging from 0-10. Zero represents no pain; worsening pain signified by increasing reported numbers with 10 being the upper limit and the worst pain possible. Only the numbers can be answers, meaning that there are only 11 possible answers on the 0-10 scale. |
| Pulmonary function | 96 hours | Pulmonary function measured by incentive spirometry |
| Supplemental oxygen | 96 hours | Supplemental oxygen requirements |
| Oxygen saturation | 96 hours | Oxygen saturation levels |
| Pulmonary complications | 96 hours | Development of pulmonary complications: atelectasis, pneumonia, respiratory failure |
| Quantity of pain medication | 96 hours | Amount of breakthrough analgesia required in morphine equivalents |
| Overall length of stay | 96 hours | Length of stay |
| ICU stay | 96 hours | Duration of ICU days |
| Costs | 96 hours | Costs associated with administration of epidural vs exparel |
| Overall complication rate | 96 hours | Overall rate of complications associated with epidural vs exparel |
| Ventilator | 96 hours | Ventilator days |
Countries
United States
Contacts
Primary ContactChadrick R Evans, MD
Backup ContactJonathan Jou, MD
Outcome results
None listed