PainNCT06185933
Lidocaine Spray vs Viscous Lidocaine Solution Plus Lidocaine Spray in Patients Undergoing Non-Sedated EGD
A study testing Lidocaine Spray and Lidocaine Viscous+Lidocane spray in people with Pain and Satisfaction, Patient, run by Sawanpracharak hospital at 1 site in Thailand.
Trial summary
This study aimed to compare the efficacy of lidocaine spray (S) alone versus lidocaine spray combined with lidocaine viscous solution (S+V) in facilitating pharyngeal observation during Non-sedating upper gastrointestinal endoscopy (UGE). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Satisfaction, Patient
- What is being tested?
- Lidocaine Spray and Lidocaine Viscous+Lidocane spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteThailand
- Study dates
- 4 Feb 2024to 30 Oct 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for upper gastrointestinal endoscopy:
- Patients who are robust, without chronic illnesses, or with controlled chronic conditions that do not adversely affect the function of any organ (American Society of Anesthesiologists (ASA) physical status classification I-II).
Who cannot join
- Has a history of receiving painkillers or sleeping pills within 24 hours before the endoscopy.
- Has a history of post-endoscopy nausea and vomiting.
- Patients who have undergone upper gastrointestinal endoscopy previously.
- Has chronic conditions such as epilepsy, vertigo, or mental health disorders.
- Has a history of allergy to anesthesia used in the study.
- Pregnant or currently breastfeeding.
- Refuses to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lidocaine Spray vs Viscous Lidocaine Solution Plus Lidocaine Spray in Patients Undergoing Non-Sedated Esophagogastroduodenoscopy: A Randomized Controlled Trial
This study aimed to compare the efficacy of lidocaine spray (S) alone versus lidocaine spray combined with lidocaine viscous solution (S+V) in facilitating pharyngeal observation during Non-sedating upper gastrointestinal endoscopy (UGE).
Read the detailed description
A randomized controlled trial was conducted between July and October 2023 at Sawanpracharak hospital, Thailand. Of 250 patients undergoing UGE, 125 were randomly assigned to group S (lidocaine spray alone) and 125 to group S+V (lidocaine spray plus lidocaine viscous solution). The total dose of lidocaine did not exceed 5 mg/kg in both groups
- Conditions
- Pain, Satisfaction, Patient
- Being tested
- Lidocaine Spray, Lidocaine Viscous+Lidocane spray
- Keywords
- lidocaine spray, lidocaine solution, non-sedating EGD
- Medical subject headings
- Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine SprayDrug
Also called liocaine spray
Pharyngeal anesthesia using a topical lidocaine spray was administered in the preprocedure room, in the absence of the endoscopist or the research assistant. 5 minute before the UGE without any sedation
Lidocaine Viscous+Lidocane sprayDrug
Also called Lidocaine Viscous, Lidocane spray
Pharyngeal anesthesia using topical viscous lidocaine solution + lidocaine spray were administered in the preprocedure room, in the absence of the endoscopist or the research assistant. 5 minute before the UGE without any sedation
| Study group | Role | What they receive |
|---|---|---|
| lidocaine spray alone | Active comparator | patient in this arm will receive lidocaine spray five puffs of 10 % lidocaine spray (Xylocaine 10 % Spray, Astra Zeneca) (1 puff = 10 mg of lidocaine) 5 minutes before the start of the procedure Receives: Drug: Lidocaine Spray |
| receive lidocaine spray + lidocaine viscous solution | Active comparator | patient in this arm will receive lidocaine spray + lidocaine viscous solution five puffs of 10 % lidocaine spray (Xylocaine 10 % Spray, Astra Zeneca) (1 puff = 10 mg of lidocaine) Plus 5 mL of 2 % viscous lidocaine solution (20 mg/mL) (Xylocaine 2 %, Astra Zeneca, London, UK) Receives: Drug: Lidocaine Viscous+Lidocane spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
procedural pain, measured using the visual analog scale (VAS).
The procedural pain was evaluated using a visual analog scale (VAS, 0-10) with 0 being none and 10 being the most painfull
Measured: 30 minute after finished precedure
Secondary outcomes (3)
patient tolerance
1 = exceptional; 2 = well; 3 = fair; 4 = poor answer by endoscopist
Measured: immediately after finished precedure
endoscopist satisfaction
1 = very satisfied; 2 = satisfied; 3 = neutral; and 4 = dissatisfied
Measured: immediately after finished precedure
patient satisfaction
1 = very satisfied; 2 = satisfied; 3 = neutral; and 4 = dissatisfied
Measured: 30 minute after finished precedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start4 Feb 2024
- Primary completion4 Jul 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sawanpracharak hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natee Faknak, Sawanpracharak hospital
- Investigators
- Natee Faknak, Principal investigator, Saawanpracharak hospital Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185933
- Sponsor's protocol ID
- NF01
- Status last verified
- Apr 2024
- First submitted
- 15 Dec 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Faknak N, Singhattha A, Inpen T, Nopjaroonsri P. Lidocaine Spray Versus Viscous Lidocaine Solution Plus Lidocaine Spray in Patients Undergoing Non-Sedated Esophagogastroduodenoscopy: A Randomized Controlled Trial. DEN Open. 2026 Aug 5;7(1):e70393. doi: 10.1002/deo2.70393. eCollection 2027 Apr.
PubMed 42559051
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Spray vs Viscous Lidocaine Solution Plus Lidocaine Spray in Patients Undergoing Non-Sedated Esophagogastroduodenoscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06185933
- Acronym / sponsor ID
- NF01
- Conditions
- Pain, Satisfaction, Patient
- Keywords
- lidocaine spray, lidocaine solution, non-sedating EGD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sawanpracharak hospitalUniversity, hospital or other
- Study start
- 4 Feb 2024 (actual)
- Primary completion
- 4 Jul 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 29 Dec 2023 (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.
This study aimed to compare the efficacy of lidocaine spray (S) alone versus lidocaine spray combined with lidocaine viscous solution (S+V) in facilitating pharyngeal observation during Non-sedating upper gastrointestinal endoscopy (UGE).
Detailed description
A randomized controlled trial was conducted between July and October 2023 at Sawanpracharak hospital, Thailand. Of 250 patients undergoing UGE, 125 were randomly assigned to group S (lidocaine spray alone) and 125 to group S+V (lidocaine spray plus lidocaine viscous solution). The total dose of lidocaine did not exceed 5 mg/kg in both groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine spray alone | Active comparator | Drug: Lidocaine Spraypatient in this arm will receive lidocaine spray five puffs of 10 % lidocaine spray (Xylocaine 10 % Spray, Astra Zeneca) (1 puff = 10 mg of lidocaine) 5 minutes before the start of the procedure |
| receive lidocaine spray + lidocaine viscous solution | Active comparator | Drug: Lidocaine Viscous+Lidocane spraypatient in this arm will receive lidocaine spray + lidocaine viscous solution five puffs of 10 % lidocaine spray (Xylocaine 10 % Spray, Astra Zeneca) (1 puff = 10 mg of lidocaine) Plus 5 mL of 2 % viscous lidocaine solution (20 mg/mL) (Xylocaine 2 %, Astra Zeneca, London, UK) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for upper gastrointestinal endoscopy:
- Patients who are robust, without chronic illnesses, or with controlled chronic conditions that do not adversely affect the function of any organ (American Society of Anesthesiologists (ASA) physical status classification I-II).
Key exclusion criteria (7 listed)
- Has a history of receiving painkillers or sleeping pills within 24 hours before the endoscopy.
- Has a history of post-endoscopy nausea and vomiting.
- Patients who have undergone upper gastrointestinal endoscopy previously.
- Has chronic conditions such as epilepsy, vertigo, or mental health disorders.
- Has a history of allergy to anesthesia used in the study.
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 |
|---|---|---|
| Lidocaine SprayAlso: liocaine sprayPharyngeal anesthesia using a topical lidocaine spray was administered in the preprocedure room, in the absence of the endoscopist or the research assistant. 5 minute before the UGE without any sedation | Drug | lidocaine spray alone |
| Lidocaine Viscous+Lidocane sprayAlso: Lidocaine Viscous, Lidocane sprayPharyngeal anesthesia using topical viscous lidocaine solution + lidocaine spray were administered in the preprocedure room, in the absence of the endoscopist or the research assistant. 5 minute before the UGE without any sedation | Drug | receive lidocaine spray + lidocaine viscous solution |
Primary outcome
procedural pain, measured using the visual analog scale (VAS).
Time frame: 30 minute after finished precedure
The procedural pain was evaluated using a visual analog scale (VAS, 0-10) with 0 being none and 10 being the most painfull
3 secondary outcomes
patient tolerance
Time frame: immediately after finished precedure
endoscopist satisfaction
Time frame: immediately after finished precedure
patient satisfaction
Time frame: 30 minute after finished precedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 42559051Faknak N, Singhattha A, Inpen T, Nopjaroonsri P. Lidocaine Spray Versus Viscous Lidocaine Solution Plus Lidocaine Spray in Patients Undergoing Non-Sedated Esophagogastroduodenoscopy: A Randomized Controlled Trial. DEN Open. 2026 Aug 5;7(1):e70393. doi: 10.1002/deo2.70393. eCollection 2027 Apr.
- Individual participant dataSharing planned: No
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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.
Natee Faknak principal investigator
Saawanpracharak hospital Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine Spray and Lidocaine Viscous+Lidocane spray in people with Pain and Satisfaction, Patient, run by Sawanpracharak hospital at 1 site in Thailand.
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 2 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. 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 Thailand. 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. 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?
Results are not available in the source record.
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?
procedural pain, measured using the visual analog scale (VAS). (time frame: 30 minute after finished precedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06185933, which also lists 1 linked publication.
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 17 Apr 2024.