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Lidocaine Spray for Pain Control in Rib Fractures

Primary Purpose

Rib Fractures, Analgesia

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Lidocaine topical

About this trial

This is an interventional treatment trial for Rib Fractures focused on measuring Analgesia, Fentanyl, Lidocaine spray, Rib fracture, Tramadol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ankara City Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Lidocaine

Tramadol

Fentanyl

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Pain control

We use Numeric rating scala.

Secondary Outcome Measures

Full Information

NCT ID

NCT05500677

First Posted

July 29, 2022

Last Updated

August 14, 2022

Sponsor

Ankara City Hospital Bilkent

1. Study Identification

Unique Protocol Identification Number

NCT05500677

Brief Title

Lidocaine Spray for Pain Control in Rib Fractures

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

November 30, 2021 (Actual)

Study Completion Date

November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rib Fractures, Analgesia

Keywords

Analgesia, Fentanyl, Lidocaine spray, Rib fracture, Tramadol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

Pain control in rib fracture

Masking

None (Open Label)

Masking Description

open label study

Allocation

Non-Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Tramadol

Arm Type

Active Comparator

Arm Description

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

Arm Title

Fentanyl

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lidocaine topical

Other Intervention Name(s)

Tramadol hydrochloride, Fentanyl citrate

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain control

Description

We use Numeric rating scala.

Time Frame

60th minutes.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmet Burak Erdem, M.D.

Organizational Affiliation

Ankara City Hospital Bilkent

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ankara City Hospital

City

Ankara

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

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Lidocaine Spray for Pain Control in Rib Fractures

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