Comparison of Hyperbaric Prilocaine 2% 50 Mg and Hyperbaric Bupivacaine 0.5% 12.5 Mg Against Spinal Anesthesia Recovery Time in Cystoscopy Procedure
1 other identifier
interventional
66
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2022
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 2, 2022
CompletedFirst Posted
Study publicly available on registry
November 8, 2022
CompletedNovember 8, 2022
November 1, 2022
7 months
November 2, 2022
November 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Complication
24 hour
Study Arms (2)
Prilocaine
EXPERIMENTAL50 mg hyperbaric 2% prilocaine (2.5 ml volume) + 25 mcg fentanyl (0.5 ml volume)
bupivacaine
ACTIVE COMPARATOR12.5, 5 mg hyperbaric 0.5% bupivacaine (2.5 ml volume) + 25 mcg fentanyl (0.5 ml volume)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Have a history of allergy to prilocaine or bupivacaine,
- Have a previous history of walking disorders
- Spinal anesthesia is contraindicated.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430, Indonesia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
November 2, 2022
First Posted
November 8, 2022
Study Start
January 1, 2022
Primary Completion
August 1, 2022
Study Completion
November 1, 2022
Last Updated
November 8, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share