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CompletedNCT07664618Updated Jun 24, 2026

Intrathecal Injection of Hyperbaric Prilocaine Versus Hyperbaric Bupivacaine for Cystoscopic Procedures

An interventional study of Bupivacaine and Prilocaine in Intrathecal Injection, Hyperbaric Prilocaine and Hyperbaric Bupivacaine, sponsored by Helwan University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Helwan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Apr 2024, registered Jun 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Intrathecal Injection
  • Hyperbaric Prilocaine
  • Hyperbaric Bupivacaine
  • Cystoscopic Procedures
03

In context

Lead sponsor

Helwan University is the lead sponsor of 69 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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%
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Bupivacaine Group

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

    Drug: Bupivacaine

  • Experimental
    Prilocaine Group

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

    Drug: Prilocaine

Interventions

  • DrugBupivacaine

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

  • DrugPrilocaine

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

06

What researchers measure

Primary outcomes

  1. Recovery time

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

    Time frame: Till discharge (Up to 4 hours)

Secondary outcomes

  1. Incidence of side effects

    Incidence of side effects such as hypotension, bradycardia, nausea, vomiting, pruritus, and urinary retention were recorded.

    Time frame: 24 hours postoperatively

  2. Noninvasive Blood pressure

    Noninvasive Blood pressure was monitored every 3 min for the first 15 minutes.

    Time frame: Till discharge from hospital (Up to 2 hours)

  3. Heart rate

    Heart rate was monitored every 3 min for the first 15 minutes.

    Time frame: Till discharge from hospital (Up to 2 hours)

  4. Degree of patient satisfaction

    Degree of patient satisfaction was assessed on a 4-point scale (1, excellent; 2, good; 3, fair; 4, poor).

    Time frame: 24 hours postoperatively

07

Study locations

1 site
  • Helwan University
    Helwan, 11795, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07664618
Lead sponsor
Helwan University
Responsible party
Mohamed Magdy Desouky (Resident of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Helwan University, Egypt., Helwan University) — Principal investigator
First posted
Jun 24, 2026
Start date
Apr 1, 2024
Primary completion
May 31, 2025
Completion
May 31, 2025
Last update
Jun 24, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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