Lidocaine Spray for Pain Control in Rib Fractures

NCT05500677 | Completed Phase 4 FDA Drug

• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we aimed to compare the analgesic efficacy of lidocaine spray with tramadol hydrochloride and fentanyl citrate in rib fractures.

Conditions

Rib Fractures; Analgesia

Keywords

Analgesia; Fentanyl; Lidocaine spray; Rib fracture; Tramadol

Outcome Measures

Primary Outcomes (1)

• Pain control

  We use Numeric rating scala.

  60th minutes.

Study Arms (3)

Lidocaine

ACTIVE COMPARATOR

10% lidocaine spray was applied on the broken rib from a distance of 10 cm, 1-2 puffs. Each puff contains 10 mg of lidocaine.

Drug: Lidocaine topical

Tramadol

ACTIVE COMPARATOR

100 mg of tramadol hydrochloride was placed in 150 cc isotonic saline and given as a 15-minute intravenous infusion.

Drug: Lidocaine topical

Fentanyl

ACTIVE COMPARATOR

50 mcg of fentanyl citrate was given as a 15-minute intravenous infusion in 150 cc isotonic.

Drug: Lidocaine topical

Interventions

Lidocaine topical DRUG

Lidocaine spray, which is a quick and easy-to-use topical local anesthetic, will be applied as a puff to the painful area.

Also known as: Tramadol hydrochloride, Fentanyl citrate

Fentanyl; Lidocaine; Tramadol

Eligibility Criteria

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

You may qualify if:

• Open conscious
• Oriented and cooperative
• Blunt thoracic trauma and rib fracture
• Numerical rating scale (NRS) was 5 or higher

You may not qualify if:

• Patients who refused to participate in the study
• Detected or suspected pregnancy
• Known history of allergy or other adverse reaction to the drugs used in the study
• History of sedative drug use or drug addiction
• Analgesic use within 6 hours of admission to the emergency department
• Needed emergency tube thoracostomy or surgical intervention
• Hemodynamically unstable
• Open and/or infected wounds in the fracture area

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rib Fractures; Agnosia

Interventions

Lidocaine; Tramadol; Fentanyl

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ahmet Burak Erdem, M.D.

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: open label study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: Pain control in rib fracture

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 15, 2022
• Study Start: June 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)