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

• Sponsor: Indonesia University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05610007
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Anesthesia; Reaction	Drug: Prilocaine	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Hyperbaric Prilocaine 2% 50 Mg and Hyperbaric Bupivacaine 0.5% 12.5 Mg Against Spinal Anesthesia Recovery Time in Cystoscopy Procedure
• Actual Study Start Date: Jan 1, 2022
• Actual Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prilocaine 50 mg hyperbaric 2% prilocaine (2.5 ml volume) + 25 mcg fentanyl (0.5 ml volume)	Drug: Prilocaine; 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.
Active Comparator: bupivacaine 12.5, 5 mg hyperbaric 0.5% bupivacaine (2.5 ml volume) + 25 mcg fentanyl (0.5 ml volume)	Drug: Prilocaine; 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Complication [24 hour]

   Complications that occur due to spinal drug administration, such as chills, hypotension, postoperative nausea and vomiting.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo Cental National Hospital	Jakarta	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

• Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aida Rosita Tantri, PhD, Indonesia University
• ClinicalTrials.gov Identifier: NCT05610007
• Other Study ID Numbers: IndonesiaUAnes125
• First Posted: Nov 8, 2022
• Last Update Posted: Nov 8, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prilocaine

Study Results

No Results Posted as of Nov 8, 2022