Intrathecal Injection of Hyperbaric Prilocaine Versus Hyperbaric Bupivacaine for Cystoscopic Procedures

NCT07664618 | Completed

• 1 other identifier: 87-2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intrathecal Injection; Hyperbaric Prilocaine; Hyperbaric Bupivacaine; Cystoscopic Procedures

Outcome Measures

Primary Outcomes (1)

• Recovery time

  Recovery time defined as the time required until the patient is ready for discharge.

  Till discharge (Up to 4 hours)

Secondary Outcomes (4)

• Incidence of side effects

  24 hours postoperatively

• Noninvasive Blood pressure

  Till discharge from hospital (Up to 2 hours)

• Heart rate

  Till discharge from hospital (Up to 2 hours)

• Degree of patient satisfaction

  24 hours postoperatively

Study Arms (2)

Bupivacaine Group

ACTIVE COMPARATOR

Patients received 0.5% bupivacaine hyperbaric (2.5 ml) + fentanyl 25 µg (0.5 ml).

Drug: Bupivacaine

Prilocaine Group

EXPERIMENTAL

Patients received hyperbaric 2% prilocaine (2.5 ml) + fentanyl 25 µg (0.5 ml).

Drug: Prilocaine

Interventions

Prilocaine DRUG

Patients received hyperbaric 2% prilocaine (2.5 ml) + fentanyl 25 µg (0.5 ml).

Prilocaine Group

Bupivacaine DRUG

Patients received 0.5% bupivacaine hyperbaric (2.5 ml) + fentanyl 25 µg (0.5 ml).

Bupivacaine Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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%

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Helwan University

Helwan, 11795, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Prilocaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Helwan University, Egypt.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: April 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)