Pain Palliation in Forearm Fractures in the Emergency Department

NCT06588907 | Completed

• 1 other identifier: ESarcan
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Forearm Fracture; Radius Fractures; Ulnar Fracture

Keywords

Procedural sedation-analgesia; infraclavicular nerve block

Outcome Measures

Primary Outcomes (3)

• Evaluation of patients' pain levels according to the Numerical Rating Scale (NRS) after the applied protocols.

  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.

  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.

  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 Outcomes (1)

• 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.

Study Arms (2)

Group P

ACTIVE COMPARATOR

Reduction will be performed under procedural sedation analgesia (PSA)

Drug: Ketamine

Group B

ACTIVE COMPARATOR

Reduction will be performed under ultrasound-guided infraclavicular nerve block (ICB).

Drug: Bupivacaine Hydrochloride

Interventions

Bupivacaine Hydrochloride DRUG

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.

Also known as: Infraclavicular nerve block (ICB)

Group B

Ketamine DRUG

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.

Also known as: procedural sedation-analgesia

Group P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 38000, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 27918376 BACKGROUND

• 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.

  PMID: 35000358 RESULT

• 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.

  PMID: 35573547 RESULT

• Sarcan E, Erdem AB, Uysal SB, Duman E, Cebeci Z, Arik E. Pain management with ketamine procedural sedation and infraclavicular block for forearm fracture in the emergency department. Am J Emerg Med. 2025 Oct;96:256-263. doi: 10.1016/j.ajem.2025.07.012. Epub 2025 Jul 16.

  PMID: 40694916 DERIVED

MeSH Terms

Conditions

Radius Fractures; Ulna Fractures

Interventions

Bupivacaine; Ketamine

Condition Hierarchy (Ancestors)

Forearm Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Ahmet Burak Erdem

  Ankara Etlik City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: September 19, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 15, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

TU (1)