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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm 40 | Active Comparator |
| |
| arm 50 | Active Comparator | this arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in the dose of 50 mg. |
|
| arm 60 | Active Comparator | this arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in the dose of 60 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| osama M Asad, professor of anaesthesia | Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Al Ainy Hospital , Cairo University | Cairo | Egypt |
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| 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 |
|
| 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) |