Is 2% lidocaine spray administration prior to respiratory procedure effective in reducing pain of lidocaine local anaesthesia?

Not yet recruiting

Conditions: Medical and Surgical, (2) ICD-10 Condition: 8||Other Procedures,

Registration Number: CTRI/2024/05/066762

Lead Sponsor: Christian medical college

Brief Summary: The aim of this study is to assess whether there is a reduction in pain perception in patients while receiving an additional skin surface lidocaine spray just prior to intradermal lignocaine infiltration in patients undergoing respiratory procedures. Patients will be randomized into two arms (2% lidocaine spray arm and Normal saline spray arm). Pain perception in each arm following the intradermal lidocaine infiltration will be assessed with FACES pain score. Additionally, we will look into incidence of pain related adverse events like vasovagal syncope in both study groups. For this randomized controlled trial, patients will be recruited from outpatients and in patients under respiratory medicine department. Study will be conducted in bronchoscopy suite /respiratory medicine treatment room /respiratory medicine ward of CMC Vellore. It will be conducted as an Placebo controlled randomized controlled study. The main primary outcome is patient Score rated by FACES pain scale.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 172

Inclusion Criteria

Consecutive patients undergoing respiratory diagnostic and therapeutic procedures requiring administration of intradermal ligniocaine injection and Image guided diagnostic and therapeutic pleurocentesis ,Chest drain insertion, medical Image guided closed pleural biopsy thoracoscopy during study period will be considered eligible for inclusion if they are 1.Aged above 18 years 2.Hemodynamically stable.

Exclusion Criteria

1.No consent 2.Documented history of lignocaine toxicity 3.Pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the pain scores during intradermal lidocaine infiltration between two study groups i.e. 2%lidocaine spray vs Normal saline spray by using FACES score.	Baseline

Secondary Outcome Measures

Name	Time	Method
1. To compare the percentage of proportion of patients in each arm who required 2nd or more additional dose of local anesthesia to complete the procedure	2.To determine pain related adverse events(vasovagal syncope )

Trial Locations

Locations (1): Christian medical college ,Vellore
🇮🇳
Vellore, TAMIL NADU, India
Christian medical college ,Vellore
🇮🇳Vellore, TAMIL NADU, India
Dr Sobankumar
Principal investigator
9159199577
kumarsoban60@gmail.com