Hypotension After Spinal AnesthesiaPhase 2NCT07416084
Comparison of Hypotension After Spinal Anesthesia With Hyperbaric Vs Isobaric Bupivacaine in Elective Cesarean After Colloid Preloading.
A Phase 2 study testing Spinal anesthesia with hyperbaric bupivacaine and Spinal anesthesia with isobaric bupivacaine in people with Hypotension After Spinal Anesthesia, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
To assess the hemodynamic difference after spinal anesthesia with hyperbaric bupivacaine and isobaric bupivacaine in elective cesarean section Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypotension After Spinal Anesthesia
- What is being tested?
- Spinal anesthesia with hyperbaric bupivacaine and Spinal anesthesia with isobaric bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2026to 30 Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA II parturient with normal pregnancy Parturients undergoing elective cesarean section under spinal anesthesia Parturient refusing normal trial of labor, planned for ELLSCS under spinal anesthesia
Who cannot join
- Patient refusal Parturient with known drug allergy to local anesthetics Parturients undergoing emergency cesarean section Spinal anesthesia converted to general anesthesia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Liaquat National Hospital and Medical College
Karachi, Sindh, 75300
Anum Fatima, MBBS, 03341891863, anumrizvi98@gmail.com
About this study
Official title: Comparison of Maternal Hypotension After Spinal Anesthesia With Hyperbaric Bupivacaine Vs Isobaric Bupivacaine in Elective Cesarean Section With Colloid Preloading
To assess the hemodynamic difference after spinal anesthesia with hyperbaric bupivacaine and isobaric bupivacaine in elective cesarean section
- Conditions
- Hypotension After Spinal Anesthesia
- Being tested
- Spinal anesthesia with hyperbaric bupivacaine, Spinal anesthesia with isobaric bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia with hyperbaric bupivacaineDrug
Spinal anesthesia with hyperbaric bupivacaine according to height
Spinal anesthesia with isobaric bupivacaineDrug
Spinal anesthesia with Isobaric bupivacaine according to height
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric bupivacaine | Active comparator | Hyperbaric bupivacaine used for spinal anesthesia Receives: Drug: Spinal anesthesia with hyperbaric bupivacaine |
| Isobaric bupivacaine | Active comparator | Isobaric bupivacaine used for spinal anesthesia Receives: Drug: Spinal anesthesia with isobaric bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal hypotension
Incidence of maternal hypotension (MAP < 60 mm Hg or drop in MAP > 20% of the baseline) within 5 minutes after intrathecal drug administration
Measured: Baseline
Secondary outcomes (6)
Maternal heart rate trend
Maternal heart rate as bpm
Measured: Baseline
Use of vasopressors
Requirement for vasopressors
Measured: Baseline
Nausea and vomiting
incidence of nausea/vomiting due to hypotension
Measured: Baseline
APGAR score
Fetal Apgar scores at 1 and 5 minutes
Measured: Baseline
Conversion to general anesthesia
Patients requiring general anesthesia after spinal anesthesia
Measured: Baseline
Maternal MAP trend
MAP as mm Hg
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension After Spinal AnesthesiaStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anum Fatima, Liaquat National Hospital & Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416084
- Sponsor's protocol ID
- 1327-2026-LNH-ERC
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Maternal Hypotension After Spinal Anesthesia With Hyperbaric Bupivacaine Vs Isobaric Bupivacaine in Elective Cesarean Section With Colloid Preloading
- ClinicalTrials.gov ID
- NCT07416084
- Acronym / sponsor ID
- 1327-2026-LNH-ERC
- Conditions
- Hypotension After Spinal Anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 17 Feb 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.
To assess the hemodynamic difference after spinal anesthesia with hyperbaric bupivacaine and isobaric bupivacaine in elective cesarean section
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric bupivacaine | Active comparator | Drug: Spinal anesthesia with hyperbaric bupivacaineHyperbaric bupivacaine used for spinal anesthesia |
| Isobaric bupivacaine | Active comparator | Drug: Spinal anesthesia with isobaric bupivacaineIsobaric bupivacaine used for spinal anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA II parturient with normal pregnancy Parturients undergoing elective cesarean section under spinal anesthesia Parturient refusing normal trial of labor, planned for ELLSCS under spinal anesthesia
Key exclusion criteria (1 listed)
- Patient refusal Parturient with known drug allergy to local anesthetics Parturients undergoing emergency cesarean section Spinal anesthesia converted to general anesthesia.
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 with hyperbaric bupivacaineSpinal anesthesia with hyperbaric bupivacaine according to height | Drug | Hyperbaric bupivacaine |
| Spinal anesthesia with isobaric bupivacaineSpinal anesthesia with Isobaric bupivacaine according to height | Drug | Isobaric bupivacaine |
Primary outcome
Maternal hypotension
Time frame: Baseline
Incidence of maternal hypotension (MAP < 60 mm Hg or drop in MAP > 20% of the baseline) within 5 minutes after intrathecal drug administration
6 secondary outcomes
Maternal heart rate trend
Time frame: Baseline
Use of vasopressors
Time frame: Baseline
Nausea and vomiting
Time frame: Baseline
APGAR score
Time frame: Baseline
Conversion to general anesthesia
Time frame: Baseline
Maternal MAP trend
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Hypotension After Spinal Anesthesia
RecruitingObservational study
The Role of Preoperative Internal Jugular Vein Collapsibility and Perfusion Index in Predicting Hypotension After Spinal Anesthesia in Elective Cesarean Sections: A Prospective Observational Study
Postspinal Hypotension, Cesarean Birth
Active, not recruiting
Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery
Maternal Hypotension After Spinal Anesthesia
RecruitingPhase 4
Norepinephrine With Ephedrine Versus Norepinephrine Alone During Spinal Anesthesia for Cesarean Delivery
Incidence of Post-spinal Hypotension
Not yet recruiting
Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
Hypotension After Neuraxial Anesthesia, Cesarean Section
RecruitingObservational study
Pupillary Light Reflex to Predict Post-Spinal Hypotension in Elective Cesarean Delivery
Hypotension, Spinal Anesthesia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spinal anesthesia with hyperbaric bupivacaine and Spinal anesthesia with isobaric bupivacaine in people with Hypotension After Spinal Anesthesia, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
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 1 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: opening soon, as of the sponsor's last update on 17 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 Pakistan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anum Fatima, MBBS (+923341891863, anumrizvi98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal hypotension (time frame: Baseline). 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 17 Feb 2026.