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OpenTrials
Completed

NCT Number: NCT06703580

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

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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Key information

Conditions

Time to First Void After Spinal Anaesthesia

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kasr Al Ainy Hospital , Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

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

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

Treatment and study plan

Hyperbaric prilocaine 2% 40 mg

Drug

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

hyperbaric prilocaine 2% 50 mg

Drug

comparison of 3 different doses of prilocaine

hyperbaric prilocaine 2% 60 mg

Drug

this study compare 3 different doses of prilocaine

Primary outcomes

  1. Time to void; time from spinal anaesthesia to first void

    Time frame: 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 outcomes

  1. Motor block regression time

    Time frame: 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.

  2. sensory regression time

    Time frame: 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.

  3. heart rate

    Time frame: 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

  4. mean arterial pressure

    Time frame: mean arterial pressure (MAP) will be measured in mmhg every 5 minutes from the start of operation till the end of operation

  5. Incidence of complications

    Time frame: 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)

  6. Time to discharge from post operative anaesthesia unit (PACU)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: Prilocaine

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 25, 2024
Registry last updated
Feb 10, 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.