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Clinical trial

Efficacy of Hematoma Block on Postoperative Pain After Femoral Intramedullary Rodding: A Randomized Trial

ID
Name
OS19011 IRB 2019-0366
Description
The purpose of this study is to evaluate the efficacy of an intra-operative, post-fixation fracture hematoma block compared to saline control on postoperative pain control in patients with acute femoral shaft fractures. Our primary outcome measure is visual analog scale (VAS) pain scores which are recorded at regular intervals.
Trial arms
Trial start
2019-08-17
Estimated PCD
2023-02-07
Trial end
2023-02-07
Status
Completed
Phase
Early phase I
Treatment
0.5% ropivacaine
The maximal single dose of ropivacaine without vasoconstrictor is 2-3 mg/kg.9 0.5% ropivacaine has 5 mg/mL of ropivacaine. 20 mL of 0.5% ropivacaine has 100 mg of ropivacaine. 100 mg of ropivacaine can be toxic to a patient less than 33-50 kg or 73-110 lb. If a patient weighs less than 110 lb, the ropivacaine dose will be scaled down below 2 mg/kg.
Arms:
Hematoma block
Normal Saline
20ml of normal saline
Arms:
Normal saline injection
Size
88
Primary endpoint
Change in postoperative pain at 72 hours
Measured at 0, 8, 16, 24, 36, 48, and 72 hours postoperatively
Eligibility criteria
Inclusion Criteria: * Trauma patient at the University of Cincinnati Medical Center * Skeletally mature patients * Have an isolated, closed, acute traumatic femoral shaft fracture to be treated with a closed reduction and reamed intramedullary rod fixation Exclusion Criteria: * Unable to provide informed consent * Member of a vulnerable patient population * Have additional injuries * Have a history of prior existing narcotic use or chronic pain management issues on presentation
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Blinded, randomized control trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The patients and the nursing staff who assess postoperative pain will be blinded to the treatment allocation.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 88, 'type': 'ACTUAL'}}
Updated at
2023-02-16

1 organization

1 product

1 drug

1 indication

Organization
University of Cincinnati
Product
Ropivacaine
Indication
Fracture of the Femur
Drug
Varlilumab