Effect of 2% Lignocaine Solution in Pain During Removal of Nasal Pack

NCT03602287 | Withdrawn

• 1 other identifier: 14/18
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of rehydration of Merocel nasal packs with 2% Lignocaine on reducing pain and discomfort during nasal pack removal in patients undergoing septoplasty.

Conditions

Nasal Pack Removal

Keywords

anterior nasal pack; nasal pack removal; 2% lignocaine

Outcome Measures

Primary Outcomes (1)

• This study is used to determine whether re-hydrating Merocel nasal packs with 2% Lignocaine reduces pain during nasal pack removal.

  Post-operative pain severity was assessed with Visual Analogue Scale (VAS). It's a 10cm scale in which 0 represents no pain at all and 10 represents the worst pain imaginable. This would find out if rehydrating nasal pack with mentioned material decreases pain caused to the patient during pack removal.

  During Nasal pack removal at 48 hrs post operative

Study Arms (2)

2% lignocaine

ACTIVE COMPARATOR

In the Lignocaine group, 2.5 ml of 2% of lignocaine is diluted with 2.5 ml of distilled water, and the 5ml solution will be injected into the Merocel pack 15 minutes before removal of the pack. Nothing will be done to the opposite nostril, which would act as a control.

Drug: Lignocaine 2% Injection 20Ml Vial (Product)

Normal saline

PLACEBO COMPARATOR

In the Normal saline group, 5 ml of normal saline was injected into the Merocel pack 15 minutes before removal of the pack. Nothing will be done to the opposite nostril.

Drug: Normal saline

Interventions

Lignocaine 2% Injection 20Ml Vial (Product) DRUG

2.5 ml of 2% of lignocaine is diluted with 2.5 ml of distilled water, and the 5ml solution will be injected into the Merocel pack 15 minutes before removal of the pack

2% lignocaine

Normal saline DRUG

5 ml of normal saline was injected into the Merocel pack 15 minutes before removal of the pack

Normal saline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Symptomatic deviated nasal septum undergone Septoplasty surgery with bilateral anterior nasal packing

You may not qualify if:

• History of previous nasal surgeries
• Nasal polyposis
• Allergic rhinitis
• Chronic sinusitis
• Patient with neurological and psychiatric disease
• Patient with sensitivity to anesthetic agent in study
• Patients unwilling to enroll in the study

Sponsors & Collaborators

• Dhulikhel Hospital: lead

Study Sites (1)

Dhulikhel Hospital

Dhulikhel, Kavre, 45210, Nepal

Location

MeSH Terms

Interventions

Lidocaine; Injections; Pharmaceutical Preparations; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Administration Routes; Drug Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions

Study Officials

• Ashish Dhakal

  Dhulikhel Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 7, 2018
• First Posted: July 26, 2018
• Study Start: July 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 24, 2018

Record last verified: 2018-09

Locations

NE (1)