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

Cairo University (CU)

Status and phase: Enrolling; Phase 3

Conditions: Time to First Void After Spinal Anaesthesia

Treatments: Drug: Hyperbaric prilocaine 2% 40 mg; Drug: hyperbaric prilocaine 2% 60 mg; Drug: hyperbaric prilocaine 2% 50 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06703580

MS-213-2023

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

150 participants in 3 patient groups

arm 40

Active Comparator group

Treatment:

Drug: Hyperbaric prilocaine 2% 40 mg

arm 50

Active Comparator group

Description:

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

Treatment:

Drug: hyperbaric prilocaine 2% 50 mg

arm 60

Active Comparator group

Description:

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

Treatment:

Drug: hyperbaric prilocaine 2% 60 mg