Time to First Void After Spinal AnaesthesiaPhase 3PrilocaineNCT06703580
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
A Phase 3 study testing Hyperbaric prilocaine 2% 40 mg, hyperbaric prilocaine 2% 50 mg and hyperbaric prilocaine 2% 60 mg in people with Time to First Void After Spinal Anaesthesia, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Time to First Void After Spinal Anaesthesia
- What is being tested?
- Hyperbaric prilocaine 2% 40 mg, hyperbaric prilocaine 2% 50 mg and hyperbaric prilocaine 2% 60 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2024to 8 Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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. -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrathecal Hyperbaric Prilocaine in Adult Patients Undergoing Knee Arthroscopy, a Randomized Controlled Trail
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.
- Being tested
- Hyperbaric prilocaine 2% 40 mg, hyperbaric prilocaine 2% 50 mg, hyperbaric prilocaine 2% 60 mg
- Keywords
- prilocaine, intrathecal, day case, arthroscopy, time to void
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric prilocaine 2% 40 mgDrug
this arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in a dose of 40 mg.
hyperbaric prilocaine 2% 50 mgDrug
comparison of 3 different doses of prilocaine
hyperbaric prilocaine 2% 60 mgDrug
this study compare 3 different doses of prilocaine
| Study group | Role | What they receive |
|---|---|---|
| arm 40 | Active comparator | Not described Receives: Drug: Hyperbaric prilocaine 2% 40 mg |
| arm 50 | Active comparator | this arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in the dose of 50 mg. Receives: Drug: hyperbaric prilocaine 2% 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 Receives: Drug: hyperbaric prilocaine 2% 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (6)
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.
Measured: 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
sensory regression time
sensory regression time will be assessed thermally with an ice- filled plastic tube and by using wooden toothpick.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start30 Nov 2024
- Primary completion27 Dec 2025
- Study completion8 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time to First Void After Spinal AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa mahmoud bahaa eldin mohamed taha, Cairo University
- Investigators
- osama M Asad, professor of anaesthesia, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703580
- Sponsor's protocol ID
- MS-213-2023
- Acronym
- Prilocaine
- Status last verified
- Feb 2026
- First submitted
- 5 Nov 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Hyperbaric Prilocaine in Adult Patients Undergoing Knee Arthroscopy, a Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT06703580
- Acronym / sponsor ID
- Prilocaine / MS-213-2023
- Keywords
- prilocaine, intrathecal, day case, arthroscopy, time to void
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 27 Dec 2025 (actual)
- Study completion
- 8 Feb 2026 (actual)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| arm 40 | Active comparator | Drug: Hyperbaric prilocaine 2% 40 mg |
| arm 50 | Active comparator | Drug: hyperbaric prilocaine 2% 50 mgthis arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in the dose of 50 mg. |
| arm 60 | Active comparator | Drug: hyperbaric prilocaine 2% 60 mgthis arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in the dose of 60 mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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. -
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric prilocaine 2% 40 mgthis arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in a dose of 40 mg. | Drug | arm 40 |
| hyperbaric prilocaine 2% 50 mgcomparison of 3 different doses of prilocaine | Drug | arm 50 |
| hyperbaric prilocaine 2% 60 mgthis study compare 3 different doses of prilocaine | Drug | arm 60 |
Primary outcome
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.
6 secondary outcomes
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
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.
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
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
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
osama M Asad, professor of anaesthesia study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyperbaric prilocaine 2% 40 mg, hyperbaric prilocaine 2% 50 mg and hyperbaric prilocaine 2% 60 mg in people with Time to First Void After Spinal Anaesthesia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.