Clinical trial 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
Official title: Intrathecal Hyperbaric Prilocaine in Adult Patients Undergoing Knee Arthroscopy, a Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Time to First Void After Spinal Anaesthesia
Keywords: prilocaine
intrathecal
day case
arthroscopy
time to void
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to void; time from spinal anaesthesia to first void
timeFrame: 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 outcomes:
measure: Motor block regression time
timeFrame: 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
measure: sensory regression time
timeFrame: 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.
measure: heart rate
timeFrame: 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
measure: mean arterial pressure
timeFrame: mean arterial pressure (MAP) will be measured in mmhg every 5 minutes from the start of operation till the end of operation
measure: Incidence of complications
timeFrame: incidence of complications will be recorded from the start of operation till discharge from post anaesthesia care unit (PACU) assessed up to 4 hours
measure: Time to discharge from post operative anaesthesia unit (PACU)
timeFrame: 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)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Ainy Hospital , Cairo University
Study officials:
affiliation: Cairo University
name: osama M Asad, professor of anaesthesia
role: STUDY_CHAIR
References: