Intrathecal Injection of Hyperbaric Prilocaine Versus Hyperbaric Bupivacaine for Cystoscopic Procedures

Comparison Between Intrathecal Injection of Hyperbaric Prilocaine Versus Hyperbaric Bupivacaine for Cystoscopic Procedures: A Prospective Randomized Controlled Trial

This study aims to compare the intrathecal injection of hyperbaric prilocaine 2% versus hyperbaric bupivacaine 0.5% in cystoscopy procedures.

Study Overview

• Status: Completed
• Conditions: Hyperbaric Bupivacaine; Intrathecal Injection; Hyperbaric Prilocaine; Cystoscopic Procedures
• Intervention / Treatment: Drug: Bupivacaine; Drug: Prilocaine

Detailed Description

Cystoscopy is a short surgical procedure in the field of urology that is very frequently performed. Spinal anesthesia (SA) is the choice because it has an easy implementation technique, fast onset, and low complications compared to general anesthesia.

One of the spinal anesthetic regimens often used is 0.5% hyperbaric bupivacaine, which has a two-segment regression time of around 65 minutes and requires 164 minutes for complete regression to the sacral dermatomes. However, bupivacaine, when used for relatively short procedures, causes various disadvantages including prolonged effects.

Prilocaine is an alternative to bupivacaine in short surgical procedures, including cystoscopy. It has a profile similar to lidocaine but with less neurotoxicity.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Helwan, Egypt, 11795
    • Helwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age from 18 to 65 years.
• Both Sexes.
• American Society of Anesthesiologists (ASA) physical status I-II.
• Normal body mass index (BMI) 18-25.
• Undergoing cystoscopic procedure under spinal anesthesia.

Exclusion Criteria:

• - Patient's refusal.
• History of allergy to local anesthetics (hyperbaric prilocaine or hyperbaric bupivacaine).
• History of impaired gait before the study.

• Contraindications to SA including :-

  • Coagulopathy.
  • Elevated intracranial pressure (ICP).
  • Infection at the site.
  • Spinal cord disorder.
  • Severe hypovolemia.
• Uncontrolled hypertension systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg.
• Uncontrolled Diabetes mellitus HbA1c ≥ 8.5%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine Group; Patients received 0.5% bupivacaine hyperbaric (2.5 ml) + fentanyl 25 µg (0.5 ml).	Drug: Bupivacaine; Patients received 0.5% bupivacaine hyperbaric (2.5 ml) + fentanyl 25 µg (0.5 ml).
Experimental: Prilocaine Group; Patients received hyperbaric 2% prilocaine (2.5 ml) + fentanyl 25 µg (0.5 ml).	Drug: Prilocaine; Patients received hyperbaric 2% prilocaine (2.5 ml) + fentanyl 25 µg (0.5 ml).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time	Recovery time defined as the time required until the patient is ready for discharge.	Till discharge (Up to 4 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of side effects	Incidence of side effects such as hypotension, bradycardia, nausea, vomiting, pruritus, and urinary retention were recorded.	24 hours postoperatively
Noninvasive Blood pressure	Noninvasive Blood pressure was monitored every 3 min for the first 15 minutes.	Till discharge from hospital (Up to 2 hours)
Heart rate	Heart rate was monitored every 3 min for the first 15 minutes.	Till discharge from hospital (Up to 2 hours)
Degree of patient satisfaction	Degree of patient satisfaction was assessed on a 4-point scale (1, excellent; 2, good; 3, fair; 4, poor).	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Helwan University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine; Prilocaine
• Other Study ID Numbers: 87-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No