Clinical trial NCT06163027: Effect of Shotblocker on Procedure-related Pain, Satisfaction and Comfort in Patients Receiving Spinal Anesthesia
Official title: Effect of Shotblocker on Procedure-related Pain, Satisfaction and Comfort in Patients Receiving Spinal Anesthesia: Single-Blind, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Keywords: Spinal Anesthesia
Shotblocker
Pain
Satisfaction
Comfort
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Experiencing a change in consciousness,
* Patients receiving centrally or peripherally acting analgesics or sedatives
* Patients with clinical conditions requiring urgent intervention

Primary outcomes:
measure: Visual analog scale
timeFrame: up to 24 hours
Secondary outcomes:
measure: Comfort Scale
timeFrame: up to 24 hours
Other outcomes:
measure: Visual Patient Satisfaction Scale
timeFrame: up to 24 hours
Locations:
Study officials:
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