ClinicalTrials.Veeva

Menu

Pain Palliation in Forearm Fractures in the Emergency Department

A

Ankara Etlik City Hospital

Status

Completed

Conditions

Forearm Fracture
Ulnar Fracture
Radius Fractures

Treatments

Drug: Bupivacaine Hydrochloride
Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT06588907
ESarcan

Details and patient eligibility

About

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.

Full 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.

Enrollment

85 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

85 participants in 2 patient groups

Group P
Active Comparator group
Description:
Reduction will be performed under procedural sedation analgesia (PSA)
Treatment:
Drug: Ketamine
Group B
Active Comparator group
Description:
Reduction will be performed under ultrasound-guided infraclavicular nerve block (ICB).
Treatment:
Drug: Bupivacaine Hydrochloride

Trial documents
1

Trial contacts and locations

1

Loading...

Central trial contact

Emine Sarcan; Merve Yazla

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems