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Lidocaine Spray for Pain Control in Rib Fractures

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Completed
CT.gov ID
NCT05500677
Collaborator
(none)
48
Enrollment
1
Location
3
Arms
6
Actual Duration (Months)
8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lidocaine topical
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Pain control in rib fracturePain control in rib fracture
Masking:
None (Open Label)
Masking Description:
open label study
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 1, 2021
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Nov 30, 2021

Arms and Interventions

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:
  • Tramadol hydrochloride
  • Fentanyl citrate

    		•
    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:
  • Tramadol hydrochloride
  • Fentanyl citrate

    		•
    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:
  • Tramadol hydrochloride
  • Fentanyl citrate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain control [60th minutes.]

      We use Numeric rating scala.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ankara City Hospital Ankara Turkey

    Sponsors and Collaborators

    • Ankara City Hospital Bilkent

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmet Burak Erdem, M.D., Ankara City Hospital Bilkent
    ClinicalTrials.gov Identifier:
    NCT05500677
    Other Study ID Numbers:
      First Posted:
      Aug 15, 2022
      Last Update Posted:
      Aug 17, 2022
      Last Verified:
      Aug 1, 2022
      Individual Participant Data (IPD) Sharing Statement:
      No
      Plan to Share IPD:
      No
      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
      Keywords provided by Ahmet Burak Erdem, M.D., Ankara City Hospital Bilkent
      Analgesia
      Fentanyl
      Lidocaine spray
      Rib fracture
      Tramadol
      Additional relevant MeSH terms:
      Fractures, Bone
      Rib Fractures
      Lidocaine
      Fentanyl
      Tramadol

      Study Results

      No Results Posted as of Aug 17, 2022