Intrathecal InjectionNCT07664618
Intrathecal Injection of Hyperbaric Prilocaine Versus Hyperbaric Bupivacaine for Cystoscopic Procedures
A study testing Bupivacaine and Prilocaine in people with Intrathecal Injection and Hyperbaric Prilocaine, run by Helwan University at 1 site in Egypt.
Trial summary
This study aims to compare the intrathecal injection of hyperbaric prilocaine 2% versus hyperbaric bupivacaine 0.5% in cystoscopy procedures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intrathecal Injection, Hyperbaric Prilocaine, Hyperbaric Bupivacaine
- What is being tested?
- Bupivacaine and Prilocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 31 May 2025
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both Sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Normal body mass index (BMI) 18-25.
- Undergoing cystoscopic procedure under spinal anesthesia.
Who cannot join
- - Patient's refusal.
- History of allergy to local anesthetics (hyperbaric prilocaine or hyperbaric bupivacaine).
- History of impaired gait before the study.
- Contraindications to SA including :-
- Coagulopathy.
- Elevated intracranial pressure (ICP).
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- Infection at the site.
- Spinal cord disorder.
- Severe hypovolemia.
- Uncontrolled hypertension systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg.
- Uncontrolled Diabetes mellitus HbA1c ≥ 8.5%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Intrathecal Injection of Hyperbaric Prilocaine Versus Hyperbaric Bupivacaine for Cystoscopic Procedures: A Prospective Randomized Controlled Trial
This study aims to compare the intrathecal injection of hyperbaric prilocaine 2% versus hyperbaric bupivacaine 0.5% in cystoscopy procedures.
Read the detailed description
Cystoscopy is a short surgical procedure in the field of urology that is very frequently performed. Spinal anesthesia (SA) is the choice because it has an easy implementation technique, fast onset, and low complications compared to general anesthesia.
One of the spinal anesthetic regimens often used is 0.5% hyperbaric bupivacaine, which has a two-segment regression time of around 65 minutes and requires 164 minutes for complete regression to the sacral dermatomes. However, bupivacaine, when used for relatively short procedures, causes various disadvantages including prolonged effects.
Prilocaine is an alternative to bupivacaine in short surgical procedures, including cystoscopy. It has a profile similar to lidocaine but with less neurotoxicity.
- Conditions
- Intrathecal Injection, Hyperbaric Prilocaine, Hyperbaric Bupivacaine, Cystoscopic Procedures
- Being tested
- Bupivacaine, Prilocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Patients received 0.5% bupivacaine hyperbaric (2.5 ml) + fentanyl 25 µg (0.5 ml).
PrilocaineDrug
Patients received hyperbaric 2% prilocaine (2.5 ml) + fentanyl 25 µg (0.5 ml).
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine Group | Active comparator | Patients received 0.5% bupivacaine hyperbaric (2.5 ml) + fentanyl 25 µg (0.5 ml). Receives: Drug: Bupivacaine |
| Prilocaine Group | Experimental | Patients received hyperbaric 2% prilocaine (2.5 ml) + fentanyl 25 µg (0.5 ml). Receives: Drug: Prilocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time
Recovery time defined as the time required until the patient is ready for discharge.
Measured: Till discharge (Up to 4 hours)
Secondary outcomes (4)
Incidence of side effects
Incidence of side effects such as hypotension, bradycardia, nausea, vomiting, pruritus, and urinary retention were recorded.
Measured: 24 hours postoperatively
Noninvasive Blood pressure
Noninvasive Blood pressure was monitored every 3 min for the first 15 minutes.
Measured: Till discharge from hospital (Up to 2 hours)
Heart rate
Heart rate was monitored every 3 min for the first 15 minutes.
Measured: Till discharge from hospital (Up to 2 hours)
Degree of patient satisfaction
Degree of patient satisfaction was assessed on a 4-point scale (1, excellent; 2, good; 3, fair; 4, poor).
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Apr 2024
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrathecal InjectionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy Desouky, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664618
- Sponsor's protocol ID
- 87-2024
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Intrathecal Injection of Hyperbaric Prilocaine Versus Hyperbaric Bupivacaine for Cystoscopic Procedures: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07664618
- Acronym / sponsor ID
- 87-2024
- Conditions
- Intrathecal Injection, Hyperbaric Prilocaine, Hyperbaric Bupivacaine, Cystoscopic Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 24 Jun 2026 (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.
This study aims to compare the intrathecal injection of hyperbaric prilocaine 2% versus hyperbaric bupivacaine 0.5% in cystoscopy procedures.
Detailed description
Cystoscopy is a short surgical procedure in the field of urology that is very frequently performed. Spinal anesthesia (SA) is the choice because it has an easy implementation technique, fast onset, and low complications compared to general anesthesia.
One of the spinal anesthetic regimens often used is 0.5% hyperbaric bupivacaine, which has a two-segment regression time of around 65 minutes and requires 164 minutes for complete regression to the sacral dermatomes. However, bupivacaine, when used for relatively short procedures, causes various disadvantages including prolonged effects.
Prilocaine is an alternative to bupivacaine in short surgical procedures, including cystoscopy. It has a profile similar to lidocaine but with less neurotoxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine Group | Active comparator | Drug: BupivacainePatients received 0.5% bupivacaine hyperbaric (2.5 ml) + fentanyl 25 µg (0.5 ml). |
| Prilocaine Group | Experimental | Drug: PrilocainePatients received hyperbaric 2% prilocaine (2.5 ml) + fentanyl 25 µg (0.5 ml). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age from 18 to 65 years.
- Both Sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Normal body mass index (BMI) 18-25.
- Undergoing cystoscopic procedure under spinal anesthesia.
Key exclusion criteria (11 listed)
- - Patient's refusal.
- History of allergy to local anesthetics (hyperbaric prilocaine or hyperbaric bupivacaine).
- History of impaired gait before the study.
- Contraindications to SA including :-
- Uncontrolled hypertension systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg.
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 |
|---|---|---|
| BupivacainePatients received 0.5% bupivacaine hyperbaric (2.5 ml) + fentanyl 25 µg (0.5 ml). | Drug | Bupivacaine Group |
| PrilocainePatients received hyperbaric 2% prilocaine (2.5 ml) + fentanyl 25 µg (0.5 ml). | Drug | Prilocaine Group |
Primary outcome
Recovery time
Time frame: Till discharge (Up to 4 hours)
Recovery time defined as the time required until the patient is ready for discharge.
4 secondary outcomes
Incidence of side effects
Time frame: 24 hours postoperatively
Noninvasive Blood pressure
Time frame: Till discharge from hospital (Up to 2 hours)
Heart rate
Time frame: Till discharge from hospital (Up to 2 hours)
Degree of patient satisfaction
Time frame: 24 hours postoperatively
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 24 Jun 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Prilocaine in people with Intrathecal Injection and Hyperbaric Prilocaine, run by Helwan 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 5 inclusion and 11 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 24 Jun 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.
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?
Recovery time (time frame: Till discharge (Up to 4 hours)). 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 24 Jun 2026.