Clinical trial NCT03602287: Effect of 2% Lignocaine Solution in Pain During Removal of Nasal Pack
Official title: Effect of 2% Lignocaine Solution in Pain During Removal of Nasal Pack
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Nasal Pack Removal
Keywords: anterior nasal pack
nasal pack removal
2% lignocaine
Lead sponsor: Dhulikhel Hospital
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This study will be carried out in patients who have undergone septoplasty for deviated nasal septum under general anesthesia, and who are categorized as American Society of Anesthesiologists (ASA) grade I to II. Consent will be obtained from the patient for the same.

Septoplasty will be carried out under general anesthesia and in all patients Merocel nasal packs (expandable polyvinyl acetate nasal packing) that expand upon contact with fluid will be used.

The postoperative analgesia will include Ibuprofen 400mg + Paracetamol 500mg combination thrice daily and Ketorolac 30mg intravenous when needed. The packs will be removed on the second postoperative day, 48 hours after packing.

During nasal pack removal, the subjects will be randomly divided into 2 groups: the Lignocaine group (2% lignocaine HCl) and the Normal saline group (0.9% NaCl) using simple random sampling by lottery method. Subjects won't know which group they belong to and what medication they will be receiving. A 23-gauge needle will be used for direct application of the treatment to the Merocel, with care taken not to touch the patient.

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.

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.

All patients will be blinded to which group they belong and which solution was being kept in their pack.

All patients will be asked to evaluate the severity of pain during removal of nasal packing by Visual Analogue Scale (VAS) (range, 0-10; 0 = no pain and 10 = intolerable pain).

Adverse events such as vomiting and nausea will be recorded. These procedures will be done by the same team to minimize observer variations.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: This study is used to determine whether re-hydrating Merocel nasal packs with 2% Lignocaine reduces pain during nasal pack removal.
timeFrame: During Nasal pack removal at 48 hrs post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Dhulikhel
country: Nepal
facility: Dhulikhel Hospital
state: Kavre
Study officials:
affiliation: Dhulikhel Hospital
name: Ashish Dhakal
role: PRINCIPAL_INVESTIGATOR
References: