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Clinical Trials/NCT05610007
NCT05610007
Active, not recruiting
Phase 4

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

Indonesia University1 site in 1 country66 target enrollmentJanuary 1, 2022

Overview

Phase
Phase 4
Intervention
Prilocaine
Conditions
Anesthesia
Sponsor
Indonesia University
Enrollment
66
Locations
1
Primary Endpoint
Visual analog scale (VAS)
Status
Active, not recruiting
Last Updated
3 years ago

Overview

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
November 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aida Rosita Tantri

PhD

Indonesia University

Eligibility Criteria

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.

Arms & Interventions

Prilocaine

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

Intervention: Prilocaine

bupivacaine

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

Intervention: Prilocaine

Outcomes

Primary Outcomes

Visual analog scale (VAS)

Time Frame: 24 hour

Pain measurement scale felt by patients with a score of 0 = no pain and a score of 10 = unbearable severe pain.

Secondary Outcomes

  • Complication(24 hour)

Study Sites (1)

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