Clinical trial NCT06588907: Pain Palliation in Forearm Fractures in the Emergency Department
Official title: Evaluation of the Efficacy of Procedural Sedoanalgesia and Infraclavicular Nerve Blockade on Analgesia in Forearm Fractures in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Forearm Fracture
Radius Fractures
Ulnar Fracture
Keywords: Procedural sedation-analgesia
infraclavicular nerve block
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years and older,
* 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 with allergies to drugs used for sedoanalgesia and peripheral nerve blockade,
* 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.

Primary outcomes:
measure: Evaluation of patients' pain levels according to the Numerical Rating Scale (NRS) after the applied protocols.
timeFrame: 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.
measure: Success of reduction following the applied protocols.
timeFrame: 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.
measure: Evaluation of the need for additional rescue treatments during the procedure.
timeFrame: Rescue analgesia will be administered if NRS is above 5 fifteen minutes after the protocols are applied.
Secondary outcomes:
measure: Patient and practitioner satisfaction with the reduction procedure.
timeFrame: The satisfaction survey for both the patient and the reduction practitioner will be conducted 30 minutes after the reduction procedure.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Yenimahalle
Study officials:
affiliation: Ankara Etlik City Hospital
name: Ahmet Burak Erdem
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.