Three Different Doses of Intrathecal Hyperbaric Prilocaine With FentanylPhase 3NCT05726968
A Comparative Study on Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl for Optimal Dose to be Used in Elderly Patients Undergoing Day Case Lower Abdominal and Urologic Surgeries.
A Phase 3 study testing Pilocaine 2% (1.5 ml) and 25 ug fentany in people with Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl, run by Cairo University at 1 site in Egypt.
Trial summary
To compare the effects of using different doses of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg in patients scheduled for a day-case lower abdominal and urologic surgery in the geriatric patient population. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl
- What is being tested?
- Pilocaine 2% (1.5 ml) and 25 ug fentany
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Nov 2022to 5 Dec 2023
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age (65 - 80)
- ASA I - III
- Both genders.
- Height (1.60-1.90) m.
- BMI (18.5-40) kg m-2
- Scheduled for elective day-case lower abdominal or urologic procedures < 90 minutes in duration under spinal anesthesia.
- Type of surgery: Inguinal, femoral and incisional herniorrhaphies, bilateral varicocelectomies, hydrocelectomy, lymph node biopsies and mass excision biopsies, TURP surgery, Cystoscopies, ureteroscopy, bladder stone extraction, DJ insertion.
Who cannot join
- Patients requiring general anesthesia.
- Operations requiring sensory block above T10.
- Known or suspected coagulopathy (international normalised ratio > 1.4), thrombocytopenia (platelet count < 100,000).
- Known peripheral neuropathy, neurological deficits or skeletal deformities.
- Known allergy to prilocaine.
- Infection at site of injection.
- Patients' refusal to sign informed consent.
- Patients 'not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
To compare the effects of using different doses of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg in patients scheduled for a day-case lower abdominal and urologic surgery in the geriatric patient population.
Read the detailed description
- To evaluate the safety and effectiveness of spinal anaesthesia with hyperbaric Prilocaine 2% in a reduced dose (30mg) in combination with Fentanyl (25µg) in day-case lower abdominal and urologic surgeries in the geriatric population.
- To compare between three different doses of prilocaine 2% in elderly patients undergoing day case lower abdominal and urologic surgeries.
- To estimate the duration of stay in PACU and hospital stay with different doses of prilocaine 2% in elderly patients undergoing day case lower abdominal and urologic surgeries.
- Being tested
- Pilocaine 2% (1.5 ml) and 25 ug fentany
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilocaine 2% (1.5 ml) and 25 ug fentanyDrug
Also called Pilocaine 2%(2 ml) and 25 ug fentany, Pilocaine 2%(2.5 ml) and 25 ug fentany
Patients will be randomly allocated into the study groups according to the list of random numbers. The study groups will be as follows:
- Group P1 (N 15): patients assigned to this group will receive intrathecal 30 mg (1.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).
- Group P2 (N 15): patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).
- Group P3 (N 15): patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).
| Study group | Role | What they receive |
|---|---|---|
| ● Group P1 (N 15) | Active comparator | Patients assigned to this group will receive intrathecal 30 mg (1.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml). Receives: Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany |
| ● Group P2 (N 15) | Active comparator | Patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml). Receives: Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany |
| ● Group P3 (N 15) | Active comparator | patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml) Receives: Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of motor Block in hours
The primary outcome measure will be duration of motor Block in minutes, defined as the duration between intrathecal drug injection and time to unassisted ambulation or Bromage's score = 0 (no motor block).
Measured: Through Study Completion,an average of 1day
Secondary outcomes (8)
Onset of sensory block in minutes
Onset of sensory block, defined as the duration between intrathecal drug injection and complete absence of skin sensation to the pinprick test at T10 dermatome level in minutes.
Measured: Through Study Completion,an average of 1day
Onset of motor block in minutes
Onset of motor block, defined as the duration between intrathecal drug injection and reaching a Bromage's score ≥ 2 in minutes.
Measured: Through Study Completion,an average of 1day
Highest dermatomal level of sensory block.
Highest dermatomal level of sensory block.
Measured: Through Study Completion,an average of 1day
Time to reach to highest sensory block in minutes.
Time to reach to highest sensory block in minutes.
Measured: Through study completion,an average of 1day
Motor block at the time of reaching highest sensory block.
Motor block at the time of reaching highest sensory block.
Measured: through study completion,an average of 1day
Full regression of sensory block
Full regression of sensory block, defined as the duration between intrathecal drug injection and regression to the S2 dermatome in minutes.
Measured: Through Study Completion,an average of 1day
Duration of PACU stay
Duration of Post Anesthesia Care Unit stay in minutes.
Measured: Through Study Completion,an average of 1day
The incidence of adverse effects
The incidence of adverse effects like hypotension, bradycardia, apnea, nausea, shivering, pruritus, block failure and pain during the operation. Failure to achieve a block level of T10 or additional analgesia request will be considered as block failure. Hypotension will be defined as a systolic blood pressure of < 90 mmHg or a decrease in mean arterial pressure of more than 20% from baseline preoperative value and bradycardia will be defined as heart rate < 50 beat/min.
Measured: Through Study Completion,an average of 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start14 Nov 2022
- Primary completion16 Jun 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Three Different Doses of Intrathecal Hyperbaric Prilocaine With FentanylStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The purpose of this study is to determine the least sufficient dose of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg required for day-case lower abdominal and urologic surgeries , fewer adverse effects, faster recovery time, and shorter stay in post anesthesia care unit (PACU) in the geriatric patient population, as a previous study has investigated hyperbaric prilocaine (30 mg) when combined with fentanyl (20 µg) for a day-case perianal surgery, achieving a spinal anaesthesia with a mean sensory level of T9
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Norhan Abdel Aleem Ali, Hagar Hassanein Refaee, Ahmed Abdullah Fathi Mohamed Almadawi
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726968
- Sponsor's protocol ID
- MD-248-2022
- Status last verified
- Feb 2023
- First submitted
- 16 Nov 2022
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Till Study Ending
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl for Optimal Dose to be Used in Elderly Patients Undergoing Day Case Lower Abdominal and Urologic Surgeries.
- ClinicalTrials.gov ID
- NCT05726968
- Acronym / sponsor ID
- MD-248-2022
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Norhan Abdel Aleem Ali, Hagar Hassanein Refaee, Ahmed Abdullah Fathi Mohamed Almadawi
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 14 Feb 2023 (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.
To compare the effects of using different doses of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg in patients scheduled for a day-case lower abdominal and urologic surgery in the geriatric patient population.
Detailed description
- To evaluate the safety and effectiveness of spinal anaesthesia with hyperbaric Prilocaine 2% in a reduced dose (30mg) in combination with Fentanyl (25µg) in day-case lower abdominal and urologic surgeries in the geriatric population.
- To compare between three different doses of prilocaine 2% in elderly patients undergoing day case lower abdominal and urologic surgeries.
- To estimate the duration of stay in PACU and hospital stay with different doses of prilocaine 2% in elderly patients undergoing day case lower abdominal and urologic surgeries.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The purpose of this study is to determine the least sufficient dose of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg required for day-case lower abdominal and urologic surgeries , fewer adverse effects, faster recovery time, and shorter stay in post anesthesia care unit (PACU) in the geriatric patient population, as a previous study has investigated hyperbaric prilocaine (30 mg) when combined with fentanyl (20 µg) for a day-case perianal surgery, achieving a spinal anaesthesia with a mean sensory level of T9
| Arm | Type | Receives |
|---|---|---|
| ● Group P1 (N 15) | Active comparator | Drug: Pilocaine 2% (1.5 ml) and 25 ug fentanyPatients assigned to this group will receive intrathecal 30 mg (1.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml). |
| ● Group P2 (N 15) | Active comparator | Drug: Pilocaine 2% (1.5 ml) and 25 ug fentanyPatient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml). |
| ● Group P3 (N 15) | Active comparator | Drug: Pilocaine 2% (1.5 ml) and 25 ug fentanypatient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml) |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age (65 - 80)
- ASA I - III
- Both genders.
- Height (1.60-1.90) m.
- BMI (18.5-40) kg m-2
Key exclusion criteria (8 listed)
- Patients requiring general anesthesia.
- Operations requiring sensory block above T10.
- Known or suspected coagulopathy (international normalised ratio > 1.4), thrombocytopenia (platelet count < 100,000).
- Known peripheral neuropathy, neurological deficits or skeletal deformities.
- Known allergy to prilocaine.
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 |
|---|---|---|
| Pilocaine 2% (1.5 ml) and 25 ug fentanyAlso: Pilocaine 2%(2 ml) and 25 ug fentany, Pilocaine 2%(2.5 ml) and 25 ug fentanyPatients will be randomly allocated into the study groups according to the list of random numbers. The study groups will be as follows: * Group P1 (N 15): patients assigned to this group will receive intrathecal 30 mg (1.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml). * Group P2 (N 15): patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml). * Group P3 (N 15): patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml). | Drug | ● Group P1 (N 15), ● Group P2 (N 15), ● Group P3 (N 15) |
Primary outcome
Duration of motor Block in hours
Time frame: Through Study Completion,an average of 1day
The primary outcome measure will be duration of motor Block in minutes, defined as the duration between intrathecal drug injection and time to unassisted ambulation or Bromage's score = 0 (no motor block).
8 secondary outcomes
Onset of sensory block in minutes
Time frame: Through Study Completion,an average of 1day
Onset of motor block in minutes
Time frame: Through Study Completion,an average of 1day
Highest dermatomal level of sensory block.
Time frame: Through Study Completion,an average of 1day
Time to reach to highest sensory block in minutes.
Time frame: Through study completion,an average of 1day
Motor block at the time of reaching highest sensory block.
Time frame: through study completion,an average of 1day
Full regression of sensory block
Time frame: Through Study Completion,an average of 1day
Duration of PACU stay
Time frame: Through Study Completion,an average of 1day
The incidence of adverse effects
Time frame: Through Study Completion,an average of 1day
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 16 Oct 2024.
- Individual participant dataSharing planned: Undecided. Till Study Ending
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 Phase 3 study testing Pilocaine 2% (1.5 ml) and 25 ug fentany in people with Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl, 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 7 inclusion and 8 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 16 Oct 2024. 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?
Duration of motor Block in hours (time frame: Through Study Completion,an average of 1day). 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 16 Oct 2024.