Spinal AnesthesiaEarly Phase 1NCT06680167
Hyperbaric Prilocaine 2% vs Hyperbaric Bupivacaine 0.5% in Caesarean Section
A Early Phase 1 study testing Spinal anesthesia (heavy bupivacaine 0.5%) and spinal anesthesia (hyperbaric Prilocaine 2%) in people with Spinal Anesthesia, run by Sohag University at 1 site in Egypt.
Trial summary
Comparison between effects of hyperbaric bupivacaine 0.5% vs Hyperbaric prilocaine 2% in spinal anesthesia of women undergoing elective caesarean section such as onset time of sensory and motor block, duration of sensory and motor block, effects of maternal hemodynamics and expected side effects . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- Spinal anesthesia (heavy bupivacaine 0.5%) and spinal anesthesia (hyperbaric Prilocaine 2%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Oct 2024to 24 Dec 2025
- Phase
- Early Phase 1
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-45 years.
- Patients with uncomplicated pregnancies.
- American society of anesthesiologist (ASA) physical status I or II.
- Height between 155 cm and 175 cm.
- Written informed consent provided. -
Who cannot join
- Patients with known allergies to local anesthetics.
- Contraindications to intrathecal anesthesia (e.g., infection at the injection site and coagulopathy).
- Severe preeclampsia or eclampsia.
- Presence of significant comorbidities (e.g., uncontrolled diabetes, hypertension, renal or hepatic dysfunction).
- History of spinal surgery or significant spinal deformity.
- Patients who refuse to participate in the study -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Hyperbaric Prilocaine 2% Versus Hyperbaric Bupivacaine 0.5% For Intrathecal Anesthesia in Caesarean Section
Comparison between effects of hyperbaric bupivacaine 0.5% vs Hyperbaric prilocaine 2% in spinal anesthesia of women undergoing elective caesarean section such as onset time of sensory and motor block, duration of sensory and motor block, effects of maternal hemodynamics and expected side effects .
Read the detailed description
Patients will be randomly allocated into two groups:
- Prilocaine Group (Group A):
- Patients will receive 60 mg of hyperbaric prilocaine 2% intrathecally.
- The anesthetic solution will be injected intrathecally using a 25 Gauge spinal needle, with the patient in a sitting position (midline or paramedian technique).
- The injection will be performed at the L3-L4 or L4-L5 interspace.
- Bupivacaine Group (Group B):
- Patients will receive 12.5 mg of hyperbaric bupivacaine 0.5% intrathecally.
- The anesthetic solution will be injected intrathecally using a 25 Gauge spinal needle, with the patient in a sitting position (midline or paramedian technique) .
- The injection will be performed at the L3-L4 or L4-L5 interspace.
Procedure Details:
Prior to the procedure, patients will be preloaded with 500 ml of balanced crystalloid solution intravenously. Patients will be positioned in the sitting position for the spinal injection.
The chosen interspace (L3-L4 or L4-L5) will be identified, and the skin will be prepared with an antiseptic solution. A 25 Gauge spinal needle will be used for the intrathecal injection (midline or paramedian technique). After confirming free flow of cerebrospinal fluid, the prepared anesthetic solution will be injected over 10-15 seconds. Following the injection, patients will be placed supine with a slight left lateral tilt to avoid aortocaval compression. The sensory block level will be assessed using Pinprick sensation test, and the motor block will be evaluated using the modified Bromage scale. 5 Blood pressure and heart rate will be monitored every 5 mins until the end of the surgery. In case of hypotension (systolic BP < 90 mmHg or diastolic BP < 60 mmHg), intravenous boluses of 10 mg ephedrine will be administered until blood pressure stabilizes. In case of Bradycardia with Heart rate <55 bpm atropine sulphate 0.01 mg/kg will be given intravenous. Pain Assessment will be done postoperatively via Visual analogue score (VAS) as following if score 3 or less no analgesia required if score 4-5, 1g paracetamol iv will be given if score 6-7, 30mg ketorolac iv will be given if score 7 or more, 2.5mg morphine sulphate iv will be given
- Conditions
- Spinal Anesthesia
- Being tested
- Spinal anesthesia (heavy bupivacaine 0.5%), spinal anesthesia (hyperbaric Prilocaine 2%)
- Keywords
- onset time and duration of action, effects on maternal hemodynamics intraoperative and postoperative, evaluation of pain scores postoperatively
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia (heavy bupivacaine 0.5%)Drug
12.5mg of Heavy bupivacaine 0.5% will be injected intrathecally for women undergoing elective caesarean section
spinal anesthesia (hyperbaric Prilocaine 2%)Drug
60mg of Hyperbaric Prilocaine 2% will be injected intrathecally for women undergoing elective caesarean section
| Study group | Role | What they receive |
|---|---|---|
| patients of group A will receive 60mg of hyperbaric prilocaine 2% for spinal anesthesia | Active comparator | Not described Receives: Drug: spinal anesthesia (hyperbaric Prilocaine 2%) |
| patients of group B will receive 12.5mg heavy bupivacaine for spinal anesthesia | Active comparator | Not described Receives: Drug: Spinal anesthesia (heavy bupivacaine 0.5%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurment of onset time and duration of sensory block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using pinprick sensation test in women undergoing caesarean section
Measured: 12 HOURS
2- Measurment of onset time and duration of motor block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using modified bromage scale in women undergoing caesarean section
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start9 Oct 2024
- Primary completion5 Nov 2025
- Study completion24 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohamed Abdelgaber, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680167
- Sponsor's protocol ID
- Soh-Med-15-10---6MS
- Status last verified
- Mar 2026
- First submitted
- 5 Nov 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: for risk of participant data identification and for privacy concerns
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Hyperbaric Prilocaine 2% Versus Hyperbaric Bupivacaine 0.5% For Intrathecal Anesthesia in Caesarean Section
- ClinicalTrials.gov ID
- NCT06680167
- Acronym / sponsor ID
- Soh-Med-15-10---6MS
- Conditions
- Spinal Anesthesia
- Keywords
- onset time and duration of action, effects on maternal hemodynamics intraoperative and postoperative, evaluation of pain scores postoperatively
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 24 Dec 2025 (actual)
- First posted
- 8 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.
Comparison between effects of hyperbaric bupivacaine 0.5% vs Hyperbaric prilocaine 2% in spinal anesthesia of women undergoing elective caesarean section such as onset time of sensory and motor block, duration of sensory and motor block, effects of maternal hemodynamics and expected side effects .
Detailed description
Patients will be randomly allocated into two groups:
- Prilocaine Group (Group A):
- Patients will receive 60 mg of hyperbaric prilocaine 2% intrathecally.
- The anesthetic solution will be injected intrathecally using a 25 Gauge spinal needle, with the patient in a sitting position (midline or paramedian technique).
- The injection will be performed at the L3-L4 or L4-L5 interspace.
- Bupivacaine Group (Group B):
- Patients will receive 12.5 mg of hyperbaric bupivacaine 0.5% intrathecally.
- The anesthetic solution will be injected intrathecally using a 25 Gauge spinal needle, with the patient in a sitting position (midline or paramedian technique) .
- The injection will be performed at the L3-L4 or L4-L5 interspace.
Procedure Details:
Prior to the procedure, patients will be preloaded with 500 ml of balanced crystalloid solution intravenously. Patients will be positioned in the sitting position for the spinal injection.
The chosen interspace (L3-L4 or L4-L5) will be identified, and the skin will be prepared with an antiseptic solution. A 25 Gauge spinal needle will be used for the intrathecal injection (midline or paramedian technique). After confirming free flow of cerebrospinal fluid, the prepared anesthetic solution will be injected over 10-15 seconds. Following the injection, patients will be placed supine with a slight left lateral tilt to avoid aortocaval compression. The sensory block level will be assessed using Pinprick sensation test, and the motor block will be evaluated using the modified Bromage scale. 5 Blood pressure and heart rate will be monitored every 5 mins until the end of the surgery. In case of hypotension (systolic BP < 90 mmHg or diastolic BP < 60 mmHg), intravenous boluses of 10 mg ephedrine will be administered until blood pressure stabilizes. In case of Bradycardia with Heart rate <55 bpm atropine sulphate 0.01 mg/kg will be given intravenous. Pain Assessment will be done postoperatively via Visual analogue score (VAS) as following if score 3 or less no analgesia required if score 4-5, 1g paracetamol iv will be given if score 6-7, 30mg ketorolac iv will be given if score 7 or more, 2.5mg morphine sulphate iv will be given
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients of group A will receive 60mg of hyperbaric prilocaine 2% for spinal anesthesia | Active comparator | Drug: spinal anesthesia (hyperbaric Prilocaine 2%) |
| patients of group B will receive 12.5mg heavy bupivacaine for spinal anesthesia | Active comparator | Drug: Spinal anesthesia (heavy bupivacaine 0.5%) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18-45 years.
- Patients with uncomplicated pregnancies.
- American society of anesthesiologist (ASA) physical status I or II.
- Height between 155 cm and 175 cm.
- Written informed consent provided. -
Key exclusion criteria (6 listed)
- Patients with known allergies to local anesthetics.
- Contraindications to intrathecal anesthesia (e.g., infection at the injection site and coagulopathy).
- Severe preeclampsia or eclampsia.
- Presence of significant comorbidities (e.g., uncontrolled diabetes, hypertension, renal or hepatic dysfunction).
- History of spinal surgery or significant spinal deformity.
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 |
|---|---|---|
| Spinal anesthesia (heavy bupivacaine 0.5%)12.5mg of Heavy bupivacaine 0.5% will be injected intrathecally for women undergoing elective caesarean section | Drug | patients of group B will receive 12.5mg heavy bupivacaine for spinal anesthesia |
| spinal anesthesia (hyperbaric Prilocaine 2%)60mg of Hyperbaric Prilocaine 2% will be injected intrathecally for women undergoing elective caesarean section | Drug | patients of group A will receive 60mg of hyperbaric prilocaine 2% for spinal anesthesia |
Primary outcome
Measurment of onset time and duration of sensory block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using pinprick sensation test in women undergoing caesarean section
Time frame: 12 HOURS
2- Measurment of onset time and duration of motor block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using modified bromage scale in women undergoing caesarean section
Time frame: 12 hours
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 30 Mar 2026.
- Individual participant dataSharing planned: No. for risk of participant data identification and for privacy concerns
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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 Early Phase 1 study testing Spinal anesthesia (heavy bupivacaine 0.5%) and spinal anesthesia (hyperbaric Prilocaine 2%) in people with Spinal Anesthesia, run by Sohag 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 6 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 30 Mar 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Measurment of onset time and duration of sensory block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using pinprick sensation test in women undergoing caesarean section (time frame: 12 HOURS). The study lists 2 primary outcomes in all. 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 30 Mar 2026.