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

University of Indonesia (UI)

Status and phase: Active, not recruiting; Phase 4

Conditions: Anesthesia; Reaction; Anesthesia

Treatments: Drug: Prilocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05610007

IndonesiaUAnes125

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Prilocaine

Experimental group

Description:

50 mg hyperbaric 2% prilocaine (2.5 ml volume) + 25 mcg fentanyl (0.5 ml volume)

Treatment:

Drug: Prilocaine

bupivacaine

Active Comparator group

Description:

12.5, 5 mg hyperbaric 0.5% bupivacaine (2.5 ml volume) + 25 mcg fentanyl (0.5 ml volume)

Treatment:

Drug: Prilocaine