Lidocaine Spray for Pain Control in Rib Fractures

Analgesia Clinical Trial

Official title:

Comparison of the Analgesic Efficacy of Lidocaine Spray Versus Tramadol and Fentanyl for Pain Control in Rib Fractures: A Prospective, Randomized, Controlled and Open-label Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05500677
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: August 2022
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Patients over the age of 18 who came to our emergency department with blunt chest trauma were divided into three groups. Groups was created from patients who were given lidocaine 10% spray (local), i.v. 100 mg of tramadol and i.v. fentanyl 50 mcg. A total of 48 patients, each of whom were 16, were included in the study. Numerical rating scale (NRS) pain scores of the patients at baseline, 15th, 30th and 60th minutes were compared. These scores and the amount of falls at follow-up were analyzed comparatively between the 3 groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Open conscious

• Oriented and cooperative

• Blunt thoracic trauma and rib fracture

• Numerical rating scale (NRS) was 5 or higher

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Analgesia
• Fractures, Bone
• Rib Fractures

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain control	We use Numeric rating scala.	60th minutes.