Pain Palliation in Forearm Fractures in the Emergency Department
NCT ID: NCT06588907
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
85 participants
INTERVENTIONAL
2024-06-01
2024-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group P
Reduction will be performed under procedural sedation analgesia (PSA)
Ketamine
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.
Group B
Reduction will be performed under ultrasound-guided infraclavicular nerve block (ICB).
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.
Interventions
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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.
Ketamine
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with forearm fracture using standard radiography,
* Hemodynamically stable individuals,
* Without vascular or nerve injury,
* Without infection in the skin or tissues where the needle will pass,
* Able to provide written and verbal consent and are capable of giving consent
Exclusion Criteria
* Those who are hemodynamically unstable,
* Patients with ASA (American Society of Anesthesiologists) classification 3-4 will not be included in the group for whom PSA will be applied,
* Patients with coagulopathy, liver, or kidney failure,
* Patients with opioid, alcohol, or substance dependency,
* Those with skin infections or open wounds in the area where local anesthetic will be administered,
* Pregnant or suspected pregnant individuals,
* Those who do not provide written and verbal consent.
18 Years
ALL
No
Sponsors
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Ankara Etlik City Hospital
OTHER_GOV
Responsible Party
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Emine Sarcan
Doctor
Principal Investigators
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Ahmet Burak Erdem
Role: STUDY_DIRECTOR
Ankara Etlik City Hospital
Locations
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Ankara Etlik City Hospital
Ankara, Yenimahalle, Turkey (Türkiye)
Countries
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References
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Fauteux-Lamarre E, Burstein B, Cheng A, Bretholz A. Reduced Length of Stay and Adverse Events Using Bier Block for Forearm Fracture Reduction in the Pediatric Emergency Department. Pediatr Emerg Care. 2019 Jan;35(1):58-62. doi: 10.1097/PEC.0000000000000963.
Tekin E, Aydin ME, Turgut MC, Karagoz S, Ates I, Ahiskalioglu EO. Can ultrasound-guided infraclavicular block be an alternative option for forearm reduction in the emergency department? A prospective randomized study. Clin Exp Emerg Med. 2021 Dec;8(4):307-313. doi: 10.15441/ceem.20.136. Epub 2021 Dec 31.
Kukreja P, Kofskey AM, Ransom E, McKenzie C, Feinstein J, Hudson J, Kalagara H. Comparison of Supraclavicular Regional Nerve Block Versus Infraclavicular Regional Nerve Block in Distal Radial Open Reduction and Internal Fixation: A Retrospective Case Series. Cureus. 2022 Apr 12;14(4):e24079. doi: 10.7759/cureus.24079. eCollection 2022 Apr.
Sarcan E, Erdem AB, Uysal SB, Duman E, Cebeci Z, Arik E. Pain management with ketamine procedural sedation and infraclavicular block for forearm fracture in the emergency department. Am J Emerg Med. 2025 Jul 16;96:256-263. doi: 10.1016/j.ajem.2025.07.012. Online ahead of print.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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ESarcan
Identifier Type: -
Identifier Source: org_study_id