PainNCT06163027
Effect of Shotblocker on Procedure-related Pain, Satisfaction and Comfort in Patients Receiving Spinal Anesthesia
A study testing Shotblocker and Shotblocker(Plasebo) in people with Pain, run by Ataturk University.
Trial summary
Although spinal anesthesia, which is increasingly common today, is a fast and reliable method, many patients are afraid of this procedure due to their fear of needles. Different methods have been studied to reduce pain during spinal needle insertion. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Shotblocker and Shotblocker(Plasebo)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 30 Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years or older
- Does not have a disease that may cause loss of sensation or loss of sensation
- Be open to communication
- Volunteering to participate in research
Who cannot join
- Experiencing a change in consciousness,
- Patients receiving centrally or peripherally acting analgesics or sedatives
- Patients with clinical conditions requiring urgent intervention
About this study
Official title: Effect of Shotblocker on Procedure-related Pain, Satisfaction and Comfort in Patients Receiving Spinal Anesthesia: Single-Blind, Randomized Controlled Study
Although spinal anesthesia, which is increasingly common today, is a fast and reliable method, many patients are afraid of this procedure due to their fear of needles. Different methods have been studied to reduce pain during spinal needle insertion. One of the methods used to reduce pain due to needle insertion is ShotBlocker. This non-invasive, very simple to use application involves minimal risk and can be easily integrated into the application. For this reason, the research will be conducted to determine the effect of shot blockers on procedure-related pain, satisfaction and comfort in patients who will undergo spinal anesthesia.
Read the detailed description
Spinal anesthesia is a type of anesthesia resulting from the injection of local anesthetic agents into the subarachnoid area and the blockade of the spinal nerve and dorsal root ganglia. It ensures that the patient is conscious during the operation, that spontaneous breathing continues, that the response to surgical stress is suppressed, that reflexes such as coughing and swallowing are preserved, that in addition to providing analgesia in the postoperative period, it provides rapid mobilization, facilitates the transition to early nutrition, is a low-cost technique, and has a short hospital stay. It is one of the most important advantages of spinal anesthesia. The rapid onset of effect and ease of application have made spinal anesthesia a widely preferred method in many interventions. However, most patients do not accept spinal anesthesia due to needle phobia.
The main reason for needle phobia, which is an important problem in anesthesia applications, is the occurrence of needle-related pain. Needle phobia and pain can also affect the quality of spinal anesthesia, making it difficult to administer and causing syncope.For this reason, methods such as EMLA cream, local anesthetic infiltration or application of EMLA cream before infiltration, local anesthesia application with a needle-free injection system, and vapocoolant spray are recommended to reduce superficial pain occurring under the skin / subcutaneous in spinal interventions. It has been reported that the application of local anesthetic infiltration before spinal anesthesia may cause pain during spinal needle insertion, sometimes not provide adequate analgesia, and may lead to the disappearance of anatomical signs. Local application of topical anesthetics such as EMLA cream is a painless method to reduce pain due to spinal needle insertion. However, it is recommended to apply it to the skin in a thick layer at least 30-90 minutes before the procedure to provide adequate analgesia. This situation causes various disadvantages regarding the use of EMLA cream to come to the fore. The requirement to apply it a certain time before the intervention limits its use in emergency cases. In elective cases, high and rapid patient circulation in the operating room makes it difficult to adjust the application time. Another disadvantage of EMLA cream is that it is costly. The use of local anesthetic infiltration with needle-free injection devices immediately before the procedure is also time-consuming and may interrupt the procedure and aseptic conditions if the lower or upper intervertebral space is needed for needle reinsertion. Therefore, a painless, effective and fast method is required. The shotblocker device is designed to reduce injection-related pain. ShotBlocker is reported to temporarily block peripheral nerve endings, preventing the perception and transmission of pain to the central nervous system, thus reducing pain. Pain, which is an undesirable experience for every patient, is defined as the fifth vital sign. Therefore, management of pain is very important regardless of whether it is acute or chronic. It is emphasized in the literature that the stress factors of anesthesia and surgery can be significantly reduced by relieving the pain that may occur due to various procedures. Additionally, patient satisfaction and comfort will increase. When the national and international literature was examined, only one study was found that used shotblockers to reduce pain due to spinal needle insertion. Therefore, the research was to be conducted to evaluate the effect of shot blockers on procedure-related pain, satisfaction and comfort in patients who will undergo spinal anesthesia.
- Conditions
- Pain
- Being tested
- Shotblocker, Shotblocker(Plasebo)
- Keywords
- Spinal Anesthesia, Shotblocker, Pain, Satisfaction, Comfort
- Medical subject headings
- Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotblockerDevice
Shotblocher will be administered during spinal needle injection
Shotblocker(Plasebo)Other
The back side of the shotblocher will be applied during spinal needle injection
| Study group | Role | What they receive |
|---|---|---|
| Shotblocker | Experimental | Shotblocker (experimental) group: Patients will undergo standard monitoring. The shotblocker will be sterilized before the procedure. Sterilization of the shotblocker will be controlled by the indicator on the packaging. Necessary sterilization conditions for spinal anesthesia application will be met and the procedure will be performed from the L3 -L4 or L4 -L5 spinal range. During the spinal anesthesia process, the protruding surface of the shot blocker will be placed in the area to be inserted, just before the spinal needle application. The shotblocker will be kept stationary throughout the procedure and pressure will continue to be applied. After entering for the spinal anesthesia procedure, the shot blocker will be removed. During the spinal anesthesia procedure, VAS, patient satisfaction and comfort scale will be applied to the patient in the first 1 minute and at the 24th hour after surgery. Receives: Device: Shotblocker |
| Placebo | Placebo comparator | Placebo group: Patients will undergo standard monitoring (electrocardiogram, noninvasive blood pressure, peripheral oxygen saturation). The shotblocker will be sterilized before the procedure. Sterilization of the shotblocker will be controlled by the indicator on the packaging. Necessary sterilization conditions for spinal anesthesia application will be met and the procedure will be performed from the L3 -L4 or L4 -L5 spinal range. During the spinal anesthesia procedure, the reverse side of the shotblocker (without protrusions) will be placed on the skin surface and gently pressed with the fingertips. The shotblocker will be kept stationary throughout the procedure and pressure will continue to be applied. After entering for the spinal anesthesia procedure, the shot blocker will be removed. During the spinal anesthesia procedure, VAS, patient satisfaction and comfort scale will be applied to the patient in the first 1 minute and at the 24th hour after surgery. Receives: Other: Shotblocker(Plasebo) |
| Control | No intervention | Routine treatment and care will be applied to the control group and no intervention will be made. During the spinal anesthesia procedure, VAS, patient satisfaction and comfort scale will be applied to the patient in the first 1 minute and at the 24th hour after surgery. The data obtained will be recorded in the patient diagnosis form. All interventions will be performed by the same anesthesiologist. The data will be filled in by a healthcare professional who is blinded to the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
The visual analog scale will be used to assess the patient's pain intensity. It is a self-reported scale in the form of a 10- cm ruler indicating no pain at one end and unbearable pain at the other. Accordingly, the patient is told to evaluate his/ her pain between 0 and 10, with 0 indicating "no pain" and 10 indicating "unbearable pain
Measured: up to 24 hours
Secondary outcomes (1)
Comfort Scale
Comfort scale is a measuring tool that can be used horizontally and is 10 cm long. It starts with "most comfortable situation" and ends with "most uncomfortable situation". Patients are asked to rate their comfort level on a scale of 1 to 10.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülay KILINÇ, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163027
- Sponsor's protocol ID
- tulay22
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shotblocker on Procedure-related Pain, Satisfaction and Comfort in Patients Receiving Spinal Anesthesia: Single-Blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06163027
- Acronym / sponsor ID
- tulay22
- Conditions
- Pain
- Keywords
- Spinal Anesthesia, Shotblocker, Pain, Satisfaction, Comfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 8 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.
Although spinal anesthesia, which is increasingly common today, is a fast and reliable method, many patients are afraid of this procedure due to their fear of needles. Different methods have been studied to reduce pain during spinal needle insertion. One of the methods used to reduce pain due to needle insertion is ShotBlocker. This non-invasive, very simple to use application involves minimal risk and can be easily integrated into the application. For this reason, the research will be conducted to determine the effect of shot blockers on procedure-related pain, satisfaction and comfort in patients who will undergo spinal anesthesia.
Detailed description
Spinal anesthesia is a type of anesthesia resulting from the injection of local anesthetic agents into the subarachnoid area and the blockade of the spinal nerve and dorsal root ganglia. It ensures that the patient is conscious during the operation, that spontaneous breathing continues, that the response to surgical stress is suppressed, that reflexes such as coughing and swallowing are preserved, that in addition to providing analgesia in the postoperative period, it provides rapid mobilization, facilitates the transition to early nutrition, is a low-cost technique, and has a short hospital stay. It is one of the most important advantages of spinal anesthesia. The rapid onset of effect and ease of application have made spinal anesthesia a widely preferred method in many interventions. However, most patients do not accept spinal anesthesia due to needle phobia.
The main reason for needle phobia, which is an important problem in anesthesia applications, is the occurrence of needle-related pain. Needle phobia and pain can also affect the quality of spinal anesthesia, making it difficult to administer and causing syncope.For this reason, methods such as EMLA cream, local anesthetic infiltration or application of EMLA cream before infiltration, local anesthesia application with a needle-free injection system, and vapocoolant spray are recommended to reduce superficial pain occurring under the skin / subcutaneous in spinal interventions. It has been reported that the application of local anesthetic infiltration before spinal anesthesia may cause pain during spinal needle insertion, sometimes not provide adequate analgesia, and may lead to the disappearance of anatomical signs. Local application of topical anesthetics such as EMLA cream is a painless method to reduce pain due to spinal needle insertion. However, it is recommended to apply it to the skin in a thick layer at least 30-90 minutes before the procedure to provide adequate analgesia. This situation causes various disadvantages regarding the use of EMLA cream to come to the fore. The requirement to apply it a certain time before the intervention limits its use in emergency cases. In elective cases, high and rapid patient circulation in the operating room makes it difficult to adjust the application time. Another disadvantage of EMLA cream is that it is costly. The use of local anesthetic infiltration with needle-free injection devices immediately before the procedure is also time-consuming and may interrupt the procedure and aseptic conditions if the lower or upper intervertebral space is needed for needle reinsertion. Therefore, a painless, effective and fast method is required. The shotblocker device is designed to reduce injection-related pain. ShotBlocker is reported to temporarily block peripheral nerve endings, preventing the perception and transmission of pain to the central nervous system, thus reducing pain. Pain, which is an undesirable experience for every patient, is defined as the fifth vital sign. Therefore, management of pain is very important regardless of whether it is acute or chronic. It is emphasized in the literature that the stress factors of anesthesia and surgery can be significantly reduced by relieving the pain that may occur due to various procedures. Additionally, patient satisfaction and comfort will increase. When the national and international literature was examined, only one study was found that used shotblockers to reduce pain due to spinal needle insertion. Therefore, the research was to be conducted to evaluate the effect of shot blockers on procedure-related pain, satisfaction and comfort in patients who will undergo spinal anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shotblocker | Experimental | Device: ShotblockerShotblocker (experimental) group: Patients will undergo standard monitoring. The shotblocker will be sterilized before the procedure. Sterilization of the shotblocker will be controlled by the indicator on the packaging. Necessary sterilization conditions for spinal anesthesia application will be met and the procedure will be performed from the L3 -L4 or L4 -L5 spinal range. During the spinal anesthesia process, the protruding surface of the shot blocker will be placed in the area to be inserted, just before the spinal needle application. The shotblocker will be kept stationary throughout the procedure and pressure will continue to be applied. After entering for the spinal anesthesia procedure, the shot blocker will be removed. During the spinal anesthesia procedure, VAS, patient satisfaction and comfort scale will be applied to the patient in the first 1 minute and at the 24th hour after surgery. |
| Placebo | Placebo comparator | Other: Shotblocker(Plasebo)Placebo group: Patients will undergo standard monitoring (electrocardiogram, noninvasive blood pressure, peripheral oxygen saturation). The shotblocker will be sterilized before the procedure. Sterilization of the shotblocker will be controlled by the indicator on the packaging. Necessary sterilization conditions for spinal anesthesia application will be met and the procedure will be performed from the L3 -L4 or L4 -L5 spinal range. During the spinal anesthesia procedure, the reverse side of the shotblocker (without protrusions) will be placed on the skin surface and gently pressed with the fingertips. The shotblocker will be kept stationary throughout the procedure and pressure will continue to be applied. After entering for the spinal anesthesia procedure, the shot blocker will be removed. During the spinal anesthesia procedure, VAS, patient satisfaction and comfort scale will be applied to the patient in the first 1 minute and at the 24th hour after surgery. |
| Control | No intervention | –Routine treatment and care will be applied to the control group and no intervention will be made. During the spinal anesthesia procedure, VAS, patient satisfaction and comfort scale will be applied to the patient in the first 1 minute and at the 24th hour after surgery. The data obtained will be recorded in the patient diagnosis form. All interventions will be performed by the same anesthesiologist. The data will be filled in by a healthcare professional who is blinded to the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18 years or older
- Does not have a disease that may cause loss of sensation or loss of sensation
- Be open to communication
- Volunteering to participate in research
Key exclusion criteria (3 listed)
- Experiencing a change in consciousness,
- Patients receiving centrally or peripherally acting analgesics or sedatives
- Patients with clinical conditions requiring urgent intervention
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 |
|---|---|---|
| ShotblockerShotblocher will be administered during spinal needle injection | Device | Shotblocker |
| Shotblocker(Plasebo)The back side of the shotblocher will be applied during spinal needle injection | Other | Placebo |
Primary outcome
Visual analog scale
Time frame: up to 24 hours
The visual analog scale will be used to assess the patient's pain intensity. It is a self-reported scale in the form of a 10- cm ruler indicating no pain at one end and unbearable pain at the other. Accordingly, the patient is told to evaluate his/ her pain between 0 and 10, with 0 indicating "no pain" and 10 indicating "unbearable pain
1 secondary outcome
Comfort Scale
Time frame: up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Shotblocker and Shotblocker(Plasebo) in people with Pain, run by Ataturk University.
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 4 inclusion and 3 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 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Visual analog scale (time frame: up to 24 hours). 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 8 Dec 2023.