Lidocaine Spray for Pain Control in Rib Fractures

Phase 4

Completed

• Conditions: Rib Fractures; Analgesia
• Interventions: Drug: Lidocaine topical

• Registration Number: NCT05500677
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Study First Submitted: 2022-07-29
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-11
• Last Update Submitted: 2022-08-14
• Study First Posted: 2022-08-15
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lidocaine	Lidocaine topical	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.
Tramadol	Lidocaine topical	100 mg of tramadol hydrochloride was placed in 150 cc isotonic saline and given as a 15-minute intravenous infusion.
Fentanyl	Lidocaine topical	50 mcg of fentanyl citrate was given as a 15-minute intravenous infusion in 150 cc isotonic.

Primary Outcome Measures

Name	Time	Method
Pain control	60th minutes.	We use Numeric rating scala.

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey