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Completed

NCT Number: NCT07664618

Intrathecal Injection of Hyperbaric Prilocaine Versus Hyperbaric Bupivacaine for Cystoscopic Procedures

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helwan University

Helwan, 11795, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Bupivacaine

Drug

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

Prilocaine

Drug

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

Primary outcomes

  1. Recovery time

    Time frame: Till discharge (Up to 4 hours)

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

Secondary outcomes

  1. Incidence of side effects

    Time frame: 24 hours postoperatively

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

  2. Noninvasive Blood pressure

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

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

  3. Heart rate

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

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

  4. Degree of patient satisfaction

    Time frame: 24 hours postoperatively

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

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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