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Pain Palliation in Forearm Fractures in the Emergency Department

NCT06588907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-12-27

No results posted yet for this study

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.

Conditions

  • Forearm Fracture
  • Radius Fractures
  • Ulnar Fracture

Interventions

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.

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.

Sponsors & Collaborators

  • Ankara Etlik City Hospital

    lead OTHER_GOV

Principal Investigators

  • Ahmet Burak Erdem · Ankara Etlik City Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2024-12-01
Completion
2024-12-15

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06588907 on ClinicalTrials.gov