Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06163027 |
| Other study ID # |
tulay22 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2023 |
| Est. completion date |
December 30, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Ataturk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
