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

Phase 3

Recruiting

• Conditions: Time to First Void After Spinal Anaesthesia
• Interventions: Drug: Hyperbaric prilocaine 2% 40 mg; Drug: hyperbaric prilocaine 2% 50 mg; Drug: hyperbaric prilocaine 2% 60 mg

• Registration Number: NCT06703580
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-25
• Study Start: 2024-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-04-27
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
arm 40	Hyperbaric prilocaine 2% 40 mg	-
arm 50	hyperbaric prilocaine 2% 50 mg	this arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in the dose of 50 mg.
arm 60	hyperbaric prilocaine 2% 60 mg	this arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in the dose of 60 mg

Primary Outcome Measures

Name	Time	Method
Time to void; time from spinal anaesthesia to first void	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	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.

Secondary Outcome Measures

Name	Time	Method
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
Motor block regression time	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	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.
sensory regression time	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.	sensory regression time will be assessed thermally with an ice- filled plastic tube and by using wooden toothpick.
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 complications will be recorded from the start of operation till discharge from post anaesthesia care unit (PACU) assessed up to 4 hours	incidence of hypotension, bradycardia, nausea, vomiting , headache or pruritis if it occurred or not ( as a yes or no)
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)

Trial Locations

Locations (1)

Kasr Al Ainy Hospital , Cairo University; 🇪🇬 Cairo, Egypt