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 (Prilocaine)

Intrathecal Hyperbaric Prilocaine in Adult Patients Undergoing Knee Arthroscopy, a Randomized Controlled Trail

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.

Study Overview

• Status: Completed
• Conditions: Time to First Void After Spinal Anaesthesia
• Intervention / Treatment: Drug: Hyperbaric prilocaine 2% 40 mg; Drug: hyperbaric prilocaine 2% 50 mg; Drug: hyperbaric prilocaine 2% 60 mg

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr Al Ainy Hospital , Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: arm 40	Drug: Hyperbaric prilocaine 2% 40 mg; this arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in a dose of 40 mg.
Active Comparator: arm 50; this arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in the dose of 50 mg.	Drug: hyperbaric prilocaine 2% 50 mg; comparison of 3 different doses of prilocaine
Active Comparator: arm 60; this arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in the dose of 60 mg	Drug: hyperbaric prilocaine 2% 60 mg; this study compare 3 different doses of prilocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to void; time from spinal anaesthesia to first void	we will measure the time from spinal anaesthesia to first void and compare that in the 3 groups with different doses of hyperbaric prilocaine 2% (40,50 and 60 mg) to see which group has the least time to void and so early ambulation in a day case surgery of knee arthroscopy.	from time of spinal anaesthesia as a start point till time for the participant to get up and micturate on his own (time to first void) assessed up to 4 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor block regression time	Motor block will be measured by using modified bromage score, 0 = no motor block; 1 = unable to lift the extended leg in the hips; 2 = unable to flex hips and knees but still able to flex ankles; 3 = complete motor block of the lower extremity.	The motor block will be assessed 10 min after intrathecal injection as a start point and every 30 minutes until recovery of full motor power (bromage 0) up to 4 hours postoperative
sensory regression time	sensory regression time will be assessed thermally with an ice- filled plastic tube and by using wooden toothpick.	sensory regression time will be measured 10 minutes after intrathecal block (as a start point) and then every 30 minutes until regression to two dermatomes intra-operative and until 4 hours post-operative.
heart rate		heart rate will be measured in the form of beats /min from the start of operation and every 5 minutes till the end of operation
mean arterial pressure		mean arterial pressure (MAP) will be measured in mmhg every 5 minutes from the start of operation till the end of operation
Incidence of complications	incidence of hypotension, bradycardia, nausea, vomiting , headache or pruritis if it occurred or not ( as a yes or no)	incidence of complications will be recorded from the start of operation till discharge from post anaesthesia care unit (PACU) assessed up to 4 hours
Time to discharge from post operative anaesthesia unit (PACU)		time will be recorded from the start of operation till discharge of the participant from PACU after reaching Aldrete score of 10 (up to 4 hours postoperative)

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: osama M Asad, professor of anaesthesia, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2024
• Primary Completion (Actual): December 27, 2025
• Study Completion (Actual): February 8, 2026

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: arthroscopy; intrathecal; prilocaine; day case; time to void
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Prilocaine
• Other Study ID Numbers: MS-213-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No