Nasal Pack RemovalNCT03602287
Effect of 2% Lignocaine Solution in Pain During Removal of Nasal Pack
A study testing Lignocaine 2% Injection 20Ml Vial (Product) and Normal saline in people with Nasal Pack Removal, run by Dhulikhel Hospital at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Nasal Pack Removal
- What is being tested?
- Lignocaine 2% Injection 20Ml Vial (Product) and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jul 2017to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptomatic deviated nasal septum undergone Septoplasty surgery with bilateral anterior nasal packing
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Nasal Pack Removal
- Being tested
- Lignocaine 2% Injection 20Ml Vial (Product), Normal saline
- Keywords
- anterior nasal pack, nasal pack removal, 2% lignocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Normal salineDrug
5 ml of normal saline was injected into the Merocel pack 15 minutes before removal of the pack
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During Nasal pack removal at 48 hrs post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jul 2017
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Why it stopped: the article is not a clinical trial but is a hospital based randomized comparative study. This was inadvertently uploaded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Pack RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dhulikhel Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ashish Dhakal, Dhulikhel Hospital
- Investigators
- Ashish Dhakal, Principal investigator, Dhulikhel Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602287
- Sponsor's protocol ID
- 14/18
- Status last verified
- Sep 2018
- First submitted
- 7 Jul 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 2% Lignocaine Solution in Pain During Removal of Nasal Pack
- ClinicalTrials.gov ID
- NCT03602287
- Acronym / sponsor ID
- 14/18
- Conditions
- Nasal Pack Removal
- Keywords
- anterior nasal pack, nasal pack removal, 2% lignocaine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the article is not a clinical trial but is a hospital based randomized comparative study. This was inadvertently uploaded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dhulikhel HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2% lignocaine | Active comparator | Drug: Lignocaine 2% Injection 20Ml Vial (Product)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. |
| Normal saline | Placebo comparator | Drug: Normal salineIn 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Symptomatic deviated nasal septum undergone Septoplasty surgery with bilateral anterior nasal packing
Key exclusion criteria (7 listed)
- History of previous nasal surgeries
- Nasal polyposis
- Allergic rhinitis
- Chronic sinusitis
- Patient with neurological and psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lignocaine 2% Injection 20Ml Vial (Product)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 | Drug | 2% lignocaine |
| Normal saline5 ml of normal saline was injected into the Merocel pack 15 minutes before removal of the pack | Drug | Normal saline |
Primary outcome
This study is used to determine whether re-hydrating Merocel nasal packs with 2% Lignocaine reduces pain during nasal pack removal.
Time frame: During Nasal pack removal at 48 hrs post operative
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashish Dhakal principal investigator
Dhulikhel Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lignocaine 2% Injection 20Ml Vial (Product) and Normal saline in people with Nasal Pack Removal, run by Dhulikhel Hospital at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This study is used to determine whether re-hydrating Merocel nasal packs with 2% Lignocaine reduces pain during nasal pack removal. (time frame: During Nasal pack removal at 48 hrs post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2018.