Comparison of Hyperbaric Prilocaine 2% 50 Mg and Hyperbaric Bupivacaine 0.5% 12.5 Mg Against Spinal Anesthesia Recovery Time in Cystoscopy Procedure

Study Overview
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Brief Summary
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Data regarding the comparison of recovery time from spinal anesthesia between prilocaine and bupivacaine are still relatively limited. The aim of this study was to compare the speed of recovery of spinal anesthesia with hyperbaric prilocaine 2% 50 mg compared to hyperbaric bupivacaine 0.5% 12.5 mg in cystoscopy procedures. By knowing the speed of recovery time, it is hoped that the patient will recover faster, be transferred to the treatment room faster, be safer, and the length of treatment will be shorter so that the quality of service for cystoscopy procedures and patient satisfaction is getting better.

Detailed Description
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This study is a double-blind randomized clinical trial. This study compared the speed of recovery from spinal anesthesia, as many as 66 subjects were divided into two groups, namely hyperbaric prilocaine 2% 50 mg and hyperbaric bupivacaine 0.5% 12.5 mg who would undergo a cystoscopy procedure. This research was conducted in the urological surgery room of RSCM in January - October 2022, after passing the ethical review and obtaining a location permit.

Official Title
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Comparison of Hyperbaric Prilocaine 2% 50 Mg and Hyperbaric Bupivacaine 0.5% 12.5 Mg Against Spinal Anesthesia Recovery Time in Cystoscopy Procedure

Conditions
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Anesthesia, Anesthesia; Reaction

Intervention / Treatment
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* Drug: Prilocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female over the age of 18, ASA physical status I - III, Normal body mass index according to Quetelet's index, Willing to be a research participant and comply with the research rules. Exclusion Criteria: Have a history of allergy to prilocaine or bupivacaine, Have a previous history of walking disorders Spinal anesthesia is contraindicated.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prilocaine<br>50 mg hyperbaric 2% prilocaine (2.5 ml volume) + 25 mcg fentanyl (0.5 ml volume) | Drug: Prilocaine<br>* Patients in the prilocaine group were given 50 mg hyperbaric 2% prilocaine (2.5 ml volume) + 25 mcg fentanyl (0.5 ml volume) before undergoing the cystoscopy procedure.<br>|
| Active Comparator: bupivacaine<br>12.5, 5 mg hyperbaric 0.5% bupivacaine (2.5 ml volume) + 25 mcg fentanyl (0.5 ml volume) | Drug: Prilocaine<br>* Patients in the prilocaine group were given 50 mg hyperbaric 2% prilocaine (2.5 ml volume) + 25 mcg fentanyl (0.5 ml volume) before undergoing the cystoscopy procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) | Pain measurement scale felt by patients with a score of 0 = no pain and a score of 10 = unbearable severe pain. | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication | Complications that occur due to spinal drug administration, such as chills, hypotension, postoperative nausea and vomiting. | 24 hour |