Hemondynamic Changes in Spinal AnesthesiaPhase 2NillNCT07616882
Comparison of Hemodynamic Effects of Bupivacaine in Spinal Anesthesia
A Phase 2 study testing Spinal Anesthesia (bupivacaine) in people with Hemondynamic Changes in Spinal Anesthesia, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
To assess hemodynamic changes with hyperbaric bupivacaine with spinal anesthesia Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hemondynamic Changes in Spinal Anesthesia
- What is being tested?
- Spinal Anesthesia (bupivacaine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2027to 1 Oct 2027
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I and II
- Adults 18 to 60 years of age of either gender
- height from 160 to 182cm and BMI from 15 to 29.9kg/m2
Who cannot join
- ASA III and IV
- Refusal of consent
- any known renal, hepatic, cardiac or cerebrovascular disease
- hypersensitivity to local anaesthetics drug
- spinal deformity or any contra indications to spinal anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Hemodynamic Effects of Fractionated Dose Versus Bolus Dose of Hyperbaric Bupivacaine (0.5%) in Spinal Anesthesia for Lower Limb Surgery
To assess hemodynamic changes with hyperbaric bupivacaine with spinal anesthesia
Read the detailed description
Assesment of hemodynamic changes like heart rate and blood pressure with hyperbaric bupivacaine in spinal anesthesia when given in fractionanted versus bolus dose manner
- Being tested
- Spinal Anesthesia (bupivacaine)
- Keywords
- Spinal ansethesia, Fractionated, Bolus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Anesthesia (bupivacaine)Drug
In this group B spinal Anesthesia will be given in one single shot
Spinal Anesthesia (bupivacaine)Drug
In this intervention spinal Anesthesia of bupivacaine will be given in a fractionated manner that is 2/3 of dose initially and then 1/3 after 90 seconds
| Study group | Role | What they receive |
|---|---|---|
| Group B (Bolus) | Active comparator | Group B patients will be given a bolus dose of hyperbaric bupivacaine in a bolus fashion mean all of calculated drug will be given in one shot Receives: Drug: Spinal Anesthesia (bupivacaine) |
| Group F (Fractionated) | Active comparator | In group F Spinal Anesthesia will be given as 2/3 of the initial dose will be give and then after 90 seconds remaining 1/3 dose will be given of hyperbaric bupivacaine. Receives: Drug: Spinal Anesthesia (bupivacaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure
Difference in mean arterial pressure between Group B and Group F
Measured: Baseline and up to 120 minutes
Secondary outcomes (2)
Hypotension and bradycardia
Incidence of hypotension and bradycardia after spinal Anesthesia between Group B and Group F
Measured: Baseline and up to 120 minutes
Requirement of vasopressors
Requirements of vasopressors if mean arterial pressure falls below 60mmHg during the procedure and up to 120 minutes
Measured: Baseline and up to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Apr 2027 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemondynamic Changes in 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usama Bhurgri, Liaquat National Hospital & Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616882
- Sponsor's protocol ID
- 1369-2026-LNH-ERC
- Acronym
- Nill
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 1 Jun 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hemodynamic Effects of Fractionated Dose Versus Bolus Dose of Hyperbaric Bupivacaine (0.5%) in Spinal Anesthesia for Lower Limb Surgery
- ClinicalTrials.gov ID
- NCT07616882
- Acronym / sponsor ID
- Nill / 1369-2026-LNH-ERC
- Keywords
- Spinal ansethesia, Fractionated, Bolus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 1 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.
To assess hemodynamic changes with hyperbaric bupivacaine with spinal anesthesia
Detailed description
Assesment of hemodynamic changes like heart rate and blood pressure with hyperbaric bupivacaine in spinal anesthesia when given in fractionanted versus bolus dose manner
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B (Bolus) | Active comparator | Drug: Spinal Anesthesia (bupivacaine)Group B patients will be given a bolus dose of hyperbaric bupivacaine in a bolus fashion mean all of calculated drug will be given in one shot |
| Group F (Fractionated) | Active comparator | Drug: Spinal Anesthesia (bupivacaine)In group F Spinal Anesthesia will be given as 2/3 of the initial dose will be give and then after 90 seconds remaining 1/3 dose will be given of hyperbaric bupivacaine. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I and II
- Adults 18 to 60 years of age of either gender
- height from 160 to 182cm and BMI from 15 to 29.9kg/m2
Key exclusion criteria (5 listed)
- ASA III and IV
- Refusal of consent
- any known renal, hepatic, cardiac or cerebrovascular disease
- hypersensitivity to local anaesthetics drug
- spinal deformity or any contra indications to spinal 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 (bupivacaine)In this group B spinal Anesthesia will be given in one single shot | Drug | Group B (Bolus) |
| Spinal Anesthesia (bupivacaine)In this intervention spinal Anesthesia of bupivacaine will be given in a fractionated manner that is 2/3 of dose initially and then 1/3 after 90 seconds | Drug | Group F (Fractionated) |
Primary outcome
Mean Arterial Pressure
Time frame: Baseline and up to 120 minutes
Difference in mean arterial pressure between Group B and Group F
2 secondary outcomes
Hypotension and bradycardia
Time frame: Baseline and up to 120 minutes
Requirement of vasopressors
Time frame: Baseline and up to 120 minutes
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 1 Jun 2026.
- Individual participant dataSharing planned: No
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 (bupivacaine) in people with Hemondynamic Changes in 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 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: opening soon, as of the sponsor's last update on 1 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 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 Usama, MBBS (+923008978791, bhurgriusama@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Pressure (time frame: Baseline and up to 120 minutes). 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 1 Jun 2026.