University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108, United States
NCT Number: NCT05086224
The investigators objective of this study is to evaluate the effectiveness of hematoma block versus intravenous regional anesthesia (Bier block) during closed reduction of distal radius fractures.
This study is active but is not currently recruiting participants.
18 year–80 year
All sexes
Interventional
Early Phase 1
Salt Lake City, Utah, 84108, United States
The investigators objective of this study is to evaluate the effectiveness of hematoma block compared to intravenous regional anesthesia (Bier block) during closed reduction of distal radius fractures. Distal radius fractures represent one of the most commonly treated skeletal injuries in the US. Achieving a fracture reduction that restores anatomy of the distal radius is of paramount importance. Reductions that re-establish anatomical parameters can prevent a patient from requiring operative intervention for the fracture, eliminating the risks as well as costs that are inherent in undergoing surgery.
Intravenous regional anesthesia (IVRA) or 'Bier block' is an effective technique used to provide anesthesia to the distal extremity. IVRA involves venous infiltration of a local anesthetic with concomitant use of a tourniquet to restrict infiltration solely to the intended extremity. Hematoma block involves local infiltration of local anesthetic directly into the site of a hematoma to provide analgesia. Both IVRA and hematoma blocks can be used to provide analgesia during a variety of procedures including fracture manipulation and reduction, but there is a paucity of data regarding the possible superiority of one means of analgesia.
To date, only a few comparative studies has been performed regarding the use of these two analgesia methods. Numerous investigators have conducted studies evaluating these two methods of analgesia; but these studies were of relatively poor quality, are older (prior to 1995) or did not individually look at all radiographic parameters that are important to orthopedic surgical providers when determining if a distal radius fracture needs surgery, particularly ulnar variance and articular step-off or gapping.
The investigators institution is one of the few in the country that utilizes bier blocks, performed by orthopedic residents, for most closed reductions in the emergency department. This quality makes the investigators institution uniquely qualified and motivated to perform the proposed investigation.
Concerns regarding the implementation of the Bier block surround its' safety profile, including possible increased risk of carpal tunnel, and in more severe cases, seizures or cardiac arrest. Despite the frequency with which investigators manage distal radius fractures, our experience has been that the major complication profile of this technique is minimal. Other studies have supported the notion that catastrophic complications are rare and the most common "complication" is tourniquet pain. These studies are limited by their nature in that anesthesia or emergency medicine providers performed the Bier blocks, while in most instances having the orthopaedic provider perform the block as well as the reduction is more efficient.
The standard of care for most institutions is to perform a closed reduction of distal radius fracture with general conscious sedation or a local hematoma block. The investigators standard of care is to perform Bier blocks as the investigators believe it results in a more anatomic reduction, due to better analgesia and patient comfort during the procedure, thus allowing for more aggressive yet tolerable manipulation. Improved reduction quality may result in less conversion from closed management in a cast to surgical intervention which has direct impact on the patients being treated as well as on the health care system at large. The investigators hypothesis is that there is both better analgesia and fracture reduction with use of Bier block compared to hematoma block.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Inject anesthetic into the hematoma site, 20 mL of 1% lidocaine without epinephrine.
Other names: Lignocaine, Xylocaine, Ztlido (lidocaine)
Intravenous anesthetic infusion, a maximum lidocaine dosing of 3 mg/kg.
Other names: Lignocaine, Xylocaine, Ztlido (lidocaine)
Time frame: Prior to fracture manipulation
VAS pain score (0 no pain - 10 severe pain)
Time frame: During anesthetic injection or infusion, an average of 10 minutes.
VAS pain score (0 no pain - 10 severe pain)
Time frame: During fracture manipulation, an average of 10 minutes.
VAS pain score (0 no pain - 10 severe pain)
Time frame: 30 minutes following fracture manipulation
VAS pain score (0 no pain - 10 severe pain)
University of Utah
Other
Hematoma Block vs. Bier Block: Which is More Effective for Closed Fracture Reduction?
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