Clinical trial

Vital Capacity in Ultrasound Guided Serratus Plane Block in Emergency Department Patients With Multiple Rib Fractures: A Randomized Controlled Trial

Name
2019-03-17
Description
I. Background: Patients with multiple rib fractures are challenging from both pulmonary and analgesia perspectives. Adequate pain management is essential in prevention of complications secondary to decreased inspiratory volume. Significant morbidity and mortality of rib fractures is secondary to severe pain that limits ribcage movement, decreases inspiratory volumes and causes inadequate cough. Decreased vital capacity predisposes patients to atelectasis, abnormal mucous clearance and pneumonia. The objective of this study is to assess the efficacy of the serratus anterior plane block (SAPB) in improvement of vital capacity in patients with multiple unilateral rib fractures when compared to conventional management with medications. Currently, evidence of efficacy of SAPB in managing pain secondary to multiple rib fractures is limited to case reports and series, none of which evaluate vital capacity. II. Significance: The findings of this study may indicate that SAPB is superior to pharmacological management in increasing vital capacity in patients with multiple unilateral rib fractures and suggest SAPB for first line therapy in patients with rib fractures. The findings may decrease the risk of pulmonary complications as well as the use of opiates in management of multiple rib fractures in the Emergency Department especially in patients with numerous comorbidities and contraindications to conventional treatment modalities. This study may support the need for training emergency medicine physicians in bedside SAPB in order to provide the optimal therapy for patient with multiple unilateral rib fractures. III. Study Objectives: The primary objectives are to evaluate whether ultrasound guided SAPB results in a greater improvement in percent predicted vital capacity compared to standard therapy with a sham injection. The investigators will also evaluate pain scores and the safety profile of the SAPB procedure compared to those receiving standard analgesia. IV. Hypothesis: The primary hypothesis is that SAPB is superior to sham injection in improving the percent of predicted vital capacity. The secondary hypothesis is that SAPB will have greater improvement in pain scores and have a superior safety profile compared to placebo injection.
Trial arms
Trial start
2021-11-01
Estimated PCD
2024-03-04
Trial end
2024-03-04
Status
Terminated
Phase
Early phase I
Treatment
Acetaminophen
receive ketamine 0.15 mg/kg IV in 100 mL normal saline over 30 minutes for pain
Arms:
Placebo injection group, serratus anterior plane block group
Bupivacain
The injection of bupivicaine into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle.
Arms:
serratus anterior plane block group
Saline
The injection of saline into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle.
Arms:
Placebo injection group
Size
3
Primary endpoint
Pain Control
60 minutes
Eligibility criteria
Inclusion Criteria: 1. 18 years or older 2. Presumed/Clinically apparent 2 or more acute unilateral rib fractures between T3-T9 3. Pain Score 5 or greater Exclusion Criteria: 1. GCS\<13 2. Penetrating trauma 3. Pregnant 4. Unable to give consent due to dementia or altered mental status 5. Unable to perform spirometry 6. Requiring immediate surgical intervention 7. Known allergy to amide-type local anesthetics 8. Signs of infection or laceration at injection site 9. Systolic BP \<100 mmHg 10. History of chronic pain, chronic use of analgesics 11. History of substance abuse 12. Painful distracting injury (injury causing significant pain that distracts the patient from having reliable scoring of rib fracture pain, i.e. femur fracture, dislocated joint) 13. If patient received any other pain medication besides ketamine prior to the block 14. Only posterior rib fractures present 15. known allergy to acetaminophen 16. Known allergy to morphine sulfate
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 3, 'type': 'ACTUAL'}}
Updated at
2024-06-11

1 organization

2 products

1 drug

1 indication

Indication
Pain
Product
Bupivacain