Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163027
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-30
Brief Title:
Effect of Shotblocker on Procedure-related Pain Satisfaction and Comfort in Patients Receiving Spinal Anesthesia
Sponsor:
Ataturk University
Organization:
Ataturk University
Study Overview
Official Title:
Effect of Shotblocker on Procedure-related Pain Satisfaction and Comfort in Patients Receiving Spinal Anesthesia Single-Blind Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 syncopeFor 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
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 syncopeFor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None