Spinal Anesthetics Causing Adverse Effects in Therapeutic UseNCT06290583
Comparing the Effect of Spinal Bupivacaine Versus Spinal Prilocaine on Maternal Blood Pressure in Cesarean Section
A study testing Bupivacaine and Prilocaine in people with Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by South Valley University at 1 site in Egypt.
Trial summary
one of the most common complications associated with spinal anesthesia is hypotension, which can have adverse effects on both the mother and the fetus. The present study compare prilocaine versus bupivacaine in spinal anesthesia on hypotension and there effect on maternal outcomes. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
- What is being tested?
- Bupivacaine and Prilocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Apr 2024to 1 Jan 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant >36 weeks singleton baby
- American Society of Anesthesiologists (ASA) physical status 2
- Age : between 18 years old and 35 years old
Who cannot join
- Pregnant women with cardiac disease and history of psychiatric illness
- Pregnant women who received spinal anesthesia and converted to general anesthesia
- Women who have sensitivity to local anesthetics,
- Women who have Eclampsia, abruption placenta or placenta previa
- Women who have coagulopathy, thrombocytopenia with platelet count less than 80,000/cm3, myasthenia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Effect of Spinal Bupivacaine Versus Spinal Prilocaine on Maternal Blood Pressure in Cesarean Section
one of the most common complications associated with spinal anesthesia is hypotension, which can have adverse effects on both the mother and the fetus. The present study compare prilocaine versus bupivacaine in spinal anesthesia on hypotension and there effect on maternal outcomes.
- Being tested
- Bupivacaine, Prilocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Intrathecal Bupivacaine
Spinal anesthesia with standard dose of bupivacaine
PrilocaineDrug
Also called Intrathecal prilocaine
Spinal anesthesia with 50 mg dose of Prilocaine.
| Study group | Role | What they receive |
|---|---|---|
| Group B | Active comparator | Patients will be given spinal anesthesia with bupivacaine (10 mg) added to morphine (100 microgram) and will be diluted with 0.9% saline to the 3 ml final volume to be injected. Receives: Drug: Bupivacaine |
| Group P | Active comparator | Patients will be given spinal anesthesia with prilocaine (50 mg) added to morphine (100 microgram) and will be diluted with 0.9% saline to the 3 ml final volume to be injected. Receives: Drug: Prilocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal arterial blood pressure
Noninvasive blood pressure will be measured at selected time frame.. Hypotension will be defined as a decrease of systolic blood pressure of at least 20% from baseline. Upon its occurrence, and/or appearance of nausea and dizziness, treatment will be immediately with ephedrine 5mg/ dose
Measured: at base line before induction and every 3 minute during the first 15 min after spinal then every 5 mins until the end of surgery and every 1 hour postoperatively for 6 hours
Secondary outcomes (2)
Evaluation of duration of motor block
the time to motor block regression (duration of motor block), defined as the time between complete block (score 1) after induction of prilocaine or bupivacaine and no motor block (score 6) on the Modified Bromage scale (1, complete motor block; 2, almost complete motor block, ability to move the feet only; 3, ability to move the knees; 4, ability to raise the leg but unable to keep it raised; 5, ability to keep the leg raised for 10 s; 6, no weakness).
Measured: will be assessed before skin incision and every 15 min intervals until the end of surgery and then at 30-min intervals until its complete regression
Total dose of ephedrine
When hypotension occurred postspinal ephedrine 5mg per dose will be given to restore blood pressure to 90% of its baseline value.
Measured: From beginning of administration of spinal anesthesia until complete regression of motor blockade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start21 Apr 2024
- Primary completion1 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Anesthetics Causing Adverse Effects in Therapeutic UseStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gaber Ahmed, South Valley University
- Investigators
- Mohamed G Ahmed, MD, Principal investigator, Lecturer in anesthesiology, intensive care and pain management, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290583
- Sponsor's protocol ID
- Prilocaine in cesarean section
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Spinal Bupivacaine Versus Spinal Prilocaine on Maternal Blood Pressure in Cesarean Section
- ClinicalTrials.gov ID
- NCT06290583
- Acronym / sponsor ID
- Prilocaine in cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 21 Apr 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 4 Mar 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.
one of the most common complications associated with spinal anesthesia is hypotension, which can have adverse effects on both the mother and the fetus. The present study compare prilocaine versus bupivacaine in spinal anesthesia on hypotension and there effect on maternal outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | Active comparator | Drug: BupivacainePatients will be given spinal anesthesia with bupivacaine (10 mg) added to morphine (100 microgram) and will be diluted with 0.9% saline to the 3 ml final volume to be injected. |
| Group P | Active comparator | Drug: PrilocainePatients will be given spinal anesthesia with prilocaine (50 mg) added to morphine (100 microgram) and will be diluted with 0.9% saline to the 3 ml final volume to be injected. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant >36 weeks singleton baby
- American Society of Anesthesiologists (ASA) physical status 2
- Age : between 18 years old and 35 years old
Key exclusion criteria (5 listed)
- Pregnant women with cardiac disease and history of psychiatric illness
- Pregnant women who received spinal anesthesia and converted to general anesthesia
- Women who have sensitivity to local anesthetics,
- Women who have Eclampsia, abruption placenta or placenta previa
- Women who have coagulopathy, thrombocytopenia with platelet count less than 80,000/cm3, myasthenia
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 |
|---|---|---|
| BupivacaineAlso: Intrathecal BupivacaineSpinal anesthesia with standard dose of bupivacaine | Drug | Group B |
| PrilocaineAlso: Intrathecal prilocaineSpinal anesthesia with 50 mg dose of Prilocaine. | Drug | Group P |
Primary outcome
Maternal arterial blood pressure
Time frame: at base line before induction and every 3 minute during the first 15 min after spinal then every 5 mins until the end of surgery and every 1 hour postoperatively for 6 hours
Noninvasive blood pressure will be measured at selected time frame.. Hypotension will be defined as a decrease of systolic blood pressure of at least 20% from baseline. Upon its occurrence, and/or appearance of nausea and dizziness, treatment will be immediately with ephedrine 5mg/ dose
2 secondary outcomes
Evaluation of duration of motor block
Time frame: will be assessed before skin incision and every 15 min intervals until the end of surgery and then at 30-min intervals until its complete regression
Total dose of ephedrine
Time frame: From beginning of administration of spinal anesthesia until complete regression of motor blockade
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 19 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
RecruitingObservational study
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Post-Dural Puncture Headache, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
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.
Mohamed G Ahmed, MD principal investigator
Lecturer in anesthesiology, intensive care and pain management, South Valley University
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 Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by South Valley 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 3 inclusion and 5 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 19 Mar 2025. 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?
Maternal arterial blood pressure (time frame: at base line before induction and every 3 minute during the first 15 min after spinal then every 5 mins until the end of surgery and every 1 hour postoperatively for 6 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 19 Mar 2025.