Lidocaine Spray for Pain Control in Rib Fractures

August 14, 2022 updated by: Ahmet Burak Erdem, Ankara City Hospital Bilkent

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine
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
Lidocaine spray, which is a quick and easy-to-use topical local anesthetic, will be applied as a puff to the painful area.
Other Names:
  • Fentanyl citrate
  • Tramadol hydrochloride
Active Comparator: Tramadol
100 mg of tramadol hydrochloride was placed in 150 cc isotonic saline and given as a 15-minute intravenous infusion.
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.
Other Names:
  • Fentanyl citrate
  • Tramadol hydrochloride
Active Comparator: Fentanyl
50 mcg of fentanyl citrate was given as a 15-minute intravenous infusion in 150 cc isotonic.
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.
Other Names:
  • Fentanyl citrate
  • Tramadol hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain control
Time Frame: 60th minutes.
We use Numeric rating scala.
60th minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Ahmet Burak Erdem, M.D., Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

July 29, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (Actual)

August 15, 2022

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 14, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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