Using Three Different Doses of Hyperbaric Prilocaine 2% Local Anaesthetic ( 40,50 and 60mg ),Through Spinal Anaesthesia in Knee Arthroscopy Patients to Compare Time to Void

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-30

Study Completion Date

2026-02-08

Brief Summary

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The goal of this randomised trial is to use a short acting local anaesthetic drug (hyperbaric prilocaine 2%) which is beneficial in short operations which are performed as a day case surgery.

in this study the investigators will use 3 different doses of prilocaine 2% (40,50 or 60 mg ) intrathecal (in spinal anaesthesia) in participants undergoing arthroscopy on the knee.

the primary outcome is to compare time to micturate (go to the bathroom) between the three groups .

the secondary outcomes are:

* time to recovery of the motor and sensory block
* time to discharge from post anesthesia care unit
* any complications ; itching, lowered blood pressure, nausea and vomiting.

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Detailed Description

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Conditions

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Time to First Void After Spinal Anaesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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arm 40

Group Type ACTIVE_COMPARATOR

Hyperbaric prilocaine 2% 40 mg

Intervention Type DRUG

this arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in a dose of 40 mg.

arm 50

this arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in the dose of 50 mg.

Group Type ACTIVE_COMPARATOR

hyperbaric prilocaine 2% 50 mg

Intervention Type DRUG

comparison of 3 different doses of prilocaine

arm 60

this arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in the dose of 60 mg

Group Type ACTIVE_COMPARATOR

hyperbaric prilocaine 2% 60 mg

Intervention Type DRUG

this study compare 3 different doses of prilocaine

Interventions

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Hyperbaric prilocaine 2% 40 mg

this arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in a dose of 40 mg.

Intervention Type DRUG

hyperbaric prilocaine 2% 50 mg

comparison of 3 different doses of prilocaine

Intervention Type DRUG

hyperbaric prilocaine 2% 60 mg

this study compare 3 different doses of prilocaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

All patients (male/female, American Society of Anesthesiologists physical status I-II, age: 18-60 years) undergoing knee arthroscopy will be eligible for the study. -

Exclusion Criteria

1. Coagulopathy and other bleeding disorders (INR more than 1.4 and platelet less than 80000)
2. Patient refusal.
3. Infection at the site of injection.
4. Allergies against prilocaine.
5. Increased intracranial pressure.
6. Severe MS and AS.
7. Sever hypovolemia.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No