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

Phase 4

Active, not recruiting

• Conditions: Anesthesia; Anesthesia; Reaction
• Interventions: Drug: Prilocaine

• Registration Number: NCT05610007
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-08-01
• Status Verified: 2022-11
• Study Completion: 2022-11-01
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-02
• Last Update Submitted: 2022-11-02
• Study First Posted: 2022-11-08
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prilocaine	Prilocaine	50 mg hyperbaric 2% prilocaine (2.5 ml volume) + 25 mcg fentanyl (0.5 ml volume)
bupivacaine	Prilocaine	12.5, 5 mg hyperbaric 0.5% bupivacaine (2.5 ml volume) + 25 mcg fentanyl (0.5 ml volume)

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS)	24 hour	Pain measurement scale felt by patients with a score of 0 = no pain and a score of 10 = unbearable severe pain.

Secondary Outcome Measures

Name	Time	Method
Complication	24 hour	Complications that occur due to spinal drug administration, such as chills, hypotension, postoperative nausea and vomiting.

Trial Locations

Locations (1)

Cipto Mangunkusumo Cental National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia