Lower Limb SurgeriesPhase 1/2NCT07751835
Effect of Height Based vs Conventional Dose of Spinal Anesthesia in Lower Limb Surgeries
A Phase 1/2 study testing Height based dose of hyperbaric bupivacaine 0.5% in people with Lower Limb Surgeries, run by Liaquat National Hospital & Medical College.
Trial summary
This study aim is to compare height based dose of spinal anesthesia vs conventional dose. Hypothesis is height based dose has less hemodynamics changes compared to conventional dosing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Surgeries
- What is being tested?
- Height based dose of hyperbaric bupivacaine 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 1 Aug 2027
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- both genders. 18-65 years age ASA physical status I and II
Who cannot join
- ASA III and IV Refusal of patient Height less than 150 cm Known allergy to study drug
About this study
Official title: Comparison of Incidence of Hemodynamics and Block Characteristics Between Height Based Versus Conventional Fixed Dose Spinal Anesthesia in Lower Limb Surgeries: a Randomized Controlled Trial
This study aim is to compare height based dose of spinal anesthesia vs conventional dose. Hypothesis is height based dose has less hemodynamics changes compared to conventional dosing.
Read the detailed description
This is a prospective, randomized, double blinded, controlled trial with minimum 6 months of data collection. Patients will be divided into two groups randomly. Group H and C each having 52 patients. Groups H will be given spinal anesthesia dose according to their height by pre determined dosing algorithm. Group C will be given a fixed dose of Hyperbaric Bupivacaine 0.5% 12.5mg (2.5ml) without adjusting it according to their height. Pateint's blood pressure and Heart rate along with sensory effect will be recorded 5,10 and 15 minutes later after spinal anesthesia. I will be recording any episode of bradycardia and hypotension and intervention needed to treat it in both the groups
- Conditions
- Lower Limb Surgeries
- Being tested
- Height based dose of hyperbaric bupivacaine 0.5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Height based dose of hyperbaric bupivacaine 0.5%Drug
Height based vs Conventional dosing of spinal anesthesia in lower limb surgeries
| Study group | Role | What they receive |
|---|---|---|
| height based spinal anesthesia dose | Active comparator | Height based dose Receives: Drug: Height based dose of hyperbaric bupivacaine 0.5% |
| Conventional dose of spinal anesthesia | Active comparator | Conventional dose of hyperbaric bupivacaine 0.5% Receives: Drug: Height based dose of hyperbaric bupivacaine 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension and Bradycardia
Measured: 6 months
Icidence of hypotension and bradycardia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb SurgeriesStudies 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zuniara Siddqui, Liaquat National Hospital & Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751835
- Sponsor's protocol ID
- Zunsidd
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Incidence of Hemodynamics and Block Characteristics Between Height Based Versus Conventional Fixed Dose Spinal Anesthesia in Lower Limb Surgeries: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07751835
- Acronym / sponsor ID
- Zunsidd
- Conditions
- Lower Limb Surgeries
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 7 Aug 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.
This study aim is to compare height based dose of spinal anesthesia vs conventional dose. Hypothesis is height based dose has less hemodynamics changes compared to conventional dosing.
Detailed description
This is a prospective, randomized, double blinded, controlled trial with minimum 6 months of data collection. Patients will be divided into two groups randomly. Group H and C each having 52 patients. Groups H will be given spinal anesthesia dose according to their height by pre determined dosing algorithm. Group C will be given a fixed dose of Hyperbaric Bupivacaine 0.5% 12.5mg (2.5ml) without adjusting it according to their height. Pateint's blood pressure and Heart rate along with sensory effect will be recorded 5,10 and 15 minutes later after spinal anesthesia. I will be recording any episode of bradycardia and hypotension and intervention needed to treat it in both the groups
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| height based spinal anesthesia dose | Active comparator | Drug: Height based dose of hyperbaric bupivacaine 0.5%Height based dose |
| Conventional dose of spinal anesthesia | Active comparator | Drug: Height based dose of hyperbaric bupivacaine 0.5%Conventional dose of hyperbaric bupivacaine 0.5% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- both genders. 18-65 years age ASA physical status I and II
Key exclusion criteria (1 listed)
- ASA III and IV Refusal of patient Height less than 150 cm Known allergy to study drug
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 |
|---|---|---|
| Height based dose of hyperbaric bupivacaine 0.5%Height based vs Conventional dosing of spinal anesthesia in lower limb surgeries | Drug | Conventional dose of spinal anesthesia, height based spinal anesthesia dose |
Primary outcome
Hypotension and Bradycardia
Time frame: 6 months
Icidence of hypotension and bradycardia
Time frame: 6 months
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 7 Aug 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Height based dose of hyperbaric bupivacaine 0.5% in people with Lower Limb Surgeries, run by Liaquat National Hospital & Medical College.
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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Hypotension and Bradycardia (time frame: 6 months). 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 7 Aug 2026.