Pain Palliation in Forearm Fractures in the Emergency Department

Not Applicable

Completed

• Conditions: Forearm Fracture; Radius Fractures; Ulnar Fracture
• Interventions: Drug: Ketamine; Drug: Bupivacaine Hydrochloride

• Registration Number: NCT06588907
• Lead Sponsor: Ankara Etlik City Hospital

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.

Study Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-08-31
• Study First Posted: 2024-09-19
• Status Verified: 2024-12
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-15
• Last Update Submitted: 2024-12-22
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P	Ketamine	Reduction will be performed under procedural sedation analgesia (PSA)
Group B	Bupivacaine Hydrochloride	Reduction will be performed under ultrasound-guided infraclavicular nerve block (ICB).

Primary Outcome Measures

Name	Time	Method
Evaluation of patients' pain levels according to the Numerical Rating Scale (NRS) after the applied protocols.	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.	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).
Success of reduction following the applied protocols.	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.	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.
Evaluation of the need for additional rescue treatments during the procedure.	Rescue analgesia will be administered if NRS is above 5 fifteen minutes after the protocols are applied.	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.

Secondary Outcome Measures

Name	Time	Method
Patient and practitioner satisfaction with the reduction procedure.	The satisfaction survey for both the patient and the reduction practitioner will be conducted 30 minutes after 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).

Trial Locations

Locations (1)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Yenimahalle, Turkey