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Effect of Shotblocker on Procedure-related Pain, Satisfaction and Comfort in Patients Receiving Spinal Anesthesia

Effect of Shotblocker on Procedure-related Pain, Satisfaction and Comfort in Patients Receiving Spinal Anesthesia: Single-Blind, Randomized Controlled Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06163027
Enrollment
90
Registered
2023-12-08
Start date
2023-12-01
Completion date
2024-12-30
Last updated
2023-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Spinal Anesthesia, Shotblocker, Pain, Satisfaction, Comfort

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.

Interventions

DEVICEShotblocker

Shotblocher will be administered during spinal needle injection

OTHERShotblocker(Plasebo)

The back side of the shotblocher will be applied during spinal needle injection

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Visual analog scaleup to 24 hoursThe 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

Secondary

MeasureTime frameDescription
Comfort Scaleup to 24 hoursComfort 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.

Other

MeasureTime frameDescription
Visual Patient Satisfaction Scaleup to 24 hoursThe visual patient satisfaction scale consists of a 100 mm horizontal line without numbers on it. At one end of the line, I am not satisfied at all; At the other end, there is the phrase I am very satisfied. With this scale, the patient is asked to determine his/her level of satisfaction with the care given and to mark the point on the line corresponding to his/her condition.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026