An interventional study of Bupivacaine Hydrochloride and Ketamine in Forearm Fracture, Radius Fractures and Ulnar Fracture, sponsored by Ankara Etlik City Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Ankara Etlik City Hospital · Not applicable, Interventional, and Treatment
The aim is to evaluate the success of reduction procedures and pain palliation in patients with forearm fractures undergoing reduction under procedural sedation-analgesia (PSA) and ultrasound (US)-guided infraclavicular nerve block (ICB) in the emergency department.
Forearm fractures are among the most frequent reasons for adults to visit the emergency department. These fractures cause significant pain both due to the fracture itself and during the reduction process. Pain management in emergency departments (ED) is crucial. Therefore, multimodal approaches are available to reduce or eliminate pain during the reduction process. The aim of this study is to evaluate the success and pain palliation of the reduction process with procedural sedation-analgesia (PSA) and with reduction under ultrasound (US)-guided infraclavicular nerve block (ICB) in patients with forearm fractures. The secondary aim is to compare patient comfort, physician comfort, side effects, length of stay in the emergency department, and the need for painkillers after discharge between these two procedures, and to identify the most suitable method. This study aims to contribute to practical applications in order to provide optimal pain control in patients with forearm fractures in emergency departments.
Patients' pain levels at arrival, pre-reduction procedure, and post-reduction procedure will be recorded using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).The success of the reduction procedure, whether further reduction attempts were necessary, and findings from post-reduction control X-rays (radial height, radial tilt, and volar tilt) will be noted and evaluated by orthopedic physicians.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 85 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
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Reduction will be performed under procedural sedation analgesia (PSA)
Drug: Ketamine
Reduction will be performed under ultrasound-guided infraclavicular nerve block (ICB).
Drug: Bupivacaine Hydrochloride
After preparing the infraclavicular block site, a 22-gauge needle, guided by ultrasound, will be placed in the 6-7 o'clock position in the same plane as the ultrasound probe. Subsequently, lateral, medial, and posterior cords described as hypoechoic nerve fascicles within hyperechoic structures will be identified. Initially, 2 mL of saline will be administered to confirm proper spread. Once confirmed, 20 mL of 0.25% bupivacaine (prepared by diluting 10 mL of 0.5% bupivacaine with 10 mL of normal saline) will be injected in fractional doses with intermittent negative aspiration. Fifteen minutes after this procedure, anesthesia depth will be assessed using a cold-hot test, followed by reduction and application of the cast.
Also known as: Infraclavicular nerve block (ICB)
Until the recovery period, patients will be closely monitored by an experienced doctor or nurse during sedation. Emergency equipment will be readily available in case of any complications. The following protocol will be used for procedural sedation-analgesia (PSA): Ketamine will be administered intravenously at a dose of 0.5-1 mg/kg. Patients with Numeric Rating Scale (NRS) scores above 5 may receive additional doses of 0.25-1 mg/kg, repeated every 5 to 10 minutes as needed.
Also known as: procedural sedation-analgesia
Evaluation of patients' pain levels according to the Numerical Rating Scale (NRS) after the applied protocols.
Pain levels at arrival, pre-reduction procedure, and post-reduction procedure will be recorded using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: 1. Pain level at the 1. minute upon presentation to the emergency room. 2. Pain level after the implementation of the protocols, i.e. 1 hour later. 3. Pain level 24 hours after the procedure.
Success of reduction following the applied protocols.
The success of the reduction procedure, whether further reduction attempts were necessary, and findings from post-reduction control X-rays (radial height, radial tilt, and volar tilt) will be noted and evaluated by orthopedic physicians.
Time frame: An x-ray will be taken before the reduction process, i.e. at 10 minutes. An x-ray will be taken at 1 hour after the reduction process.
Evaluation of the need for additional rescue treatments during the procedure.
If NRS is above 5, as first-line rescue analgesia, tramadol 50 or 100 mg IV diluted in 100 mL normal saline will be administered over 15 minutes. If pain persists above NRS 5, second-line treatment with 50 mcg fentanyl diluted in 100 mL normal saline will be administered over 15 minutes.
Time frame: Rescue analgesia will be administered if NRS is above 5 fifteen minutes after the protocols are applied.
Patient and practitioner satisfaction with the reduction procedure.
Patient and reduction practitioner satisfaction will be recorded using a 5-point Likert scale (1: very poor, 2: poor, 3: neutral, 4: good, 5: very good).
Time frame: The satisfaction survey for both the patient and the reduction practitioner will be conducted 30 minutes after the reduction procedure.
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Ankara Etlik City Hospital