Pain Palliation in Forearm Fractures in the Emergency Department

December 22, 2024 updated by: Emine Sarcan, Ankara Etlik City Hospital

Evaluation of the Efficacy of Procedural Sedoanalgesia and Infraclavicular Nerve Blockade on Analgesia in Forearm Fractures in the Emergency Department

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey, 38000
        • Ankara Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group P
Reduction will be performed under procedural sedation analgesia (PSA)
Drug: 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 Names:
  • procedural sedation-analgesia
Active Comparator: Group B
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.
Other Names:
  • Infraclavicular nerve block (ICB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of patients' pain levels according to the Numerical Rating Scale (NRS) after the applied protocols.
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.
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).
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.
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.
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.
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.
Time Frame: 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.
Rescue analgesia will be administered if NRS is above 5 fifteen minutes after the protocols are applied.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient and practitioner satisfaction with the reduction procedure.
Time Frame: 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).
The satisfaction survey for both the patient and the reduction practitioner will be conducted 30 minutes after the reduction procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Investigators

  • Study Director: Ahmet Burak Erdem, Ankara Etlik City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 15, 2024

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

August 31, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 22, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESarcan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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