Intrathecal Injection of Hyperbaric Prilocaine Versus Hyperbaric Bupivacaine for Cystoscopic Procedures

Helwan University100 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Intrathecal Injection Hyperbaric Prilocaine Hyperbaric Bupivacaine Cystoscopic Procedures

Interventions

BupivacaineDRUG

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

PrilocaineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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%

Locations (1)

Helwan University

Helwan, Egypt

Outcomes

Primary Outcomes

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

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

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)

Heart rate

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

Time frame: 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).

Time frame: 24 hours postoperatively

Data from ClinicalTrials.gov

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