Anesthesia, SpinalPhase 4NCT07684989
Comparison of Low-Dose Versus Standard-Dose Hyperbaric Bupivacaine in Spinal Anesthesia
A Phase 4 study testing Low-Dose Hyperbaric Bupivacaine and Standard-Dose Hyperbaric Bupivacaine in people with Anesthesia, Spinal and Orthopedic Procedures, run by Mayo Hospital Lahore at 1 site in Pakistan.
Trial summary
The goal of this randomized controlled trial is to determine whether low-dose hyperbaric bupivacaine provides better hemodynamic stability and postoperative recovery compared with standard-dose hyperbaric bupivacaine in elderly patients undergoing lower limb orthopedic surgery under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anesthesia, Spinal, Orthopedic Procedures, Postoperative Recovery in Elderly Patients
- What is being tested?
- Low-Dose Hyperbaric Bupivacaine and Standard-Dose Hyperbaric Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2026to 30 Jun 2027
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or female patients aged 65 years and above.
- Patients scheduled for elective lower limb orthopedic surgery under spinal anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Patients willing to participate and provide written informed consent.
Who cannot join
- Refusal to participate in the study.
- Contraindications to spinal anesthesia (e.g., infection at puncture site, coagulopathy, severe hypovolemia, raised intracranial pressure).
- Known hypersensitivity or allergy to bupivacaine.
- Severe valvular heart disease.
- Significant cardiac arrhythmias.
- Uncontrolled hypertension.
Show all 11Show fewer
- Severe hepatic or renal impairment.
- Pre-existing neurological disorders affecting lower limb motor or sensory function.
- Severe spinal deformity or previous lumbar spine surgery interfering with spinal anesthesia.
- Cognitive impairment or inability to provide informed consent.
- Emergency orthopedic procedures.
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 Low-Dose Versus Standard-Dose Hyperbaric Bupivacaine in Spinal Anesthesia: Hemodynamic Stability and Recovery Profile in Elderly Patients Undergoing Lower Limb Orthopedic Surgery
The goal of this randomized controlled trial is to determine whether low-dose hyperbaric bupivacaine provides better hemodynamic stability and postoperative recovery compared with standard-dose hyperbaric bupivacaine in elderly patients undergoing lower limb orthopedic surgery under spinal anesthesia.
The main questions it aims to answer are:
Read more
- Does low-dose hyperbaric bupivacaine reduce the incidence of intraoperative hypotension and bradycardia compared with standard-dose hyperbaric bupivacaine?
- Does low-dose hyperbaric bupivacaine improve postoperative recovery profile compared with standard-dose hyperbaric bupivacaine?
Researchers will compare elderly patients receiving low-dose hyperbaric bupivacaine with those receiving standard-dose hyperbaric bupivacaine to determine whether a lower intrathecal dose improves cardiovascular stability and recovery without compromising the effectiveness of spinal anesthesia.
Participants will:
- Provide written informed consent before enrollment.
- Undergo elective lower limb orthopedic surgery under spinal anesthesia.
- Be randomly assigned to receive either low-dose or standard-dose hyperbaric bupivacaine.
- Have their blood pressure, heart rate, and other vital signs monitored throughout the surgical procedure.
- Be assessed for intraoperative hypotension and bradycardia according to predefined study criteria.
- Be evaluated for postoperative recovery parameters, including motor recovery and readiness for postoperative recovery and mobilization.
The information obtained from this study may help identify a safer and more effective spinal anesthetic technique for elderly patients undergoing orthopedic surgery.
- Conditions
- Anesthesia, Spinal, Orthopedic Procedures, Postoperative Recovery in Elderly Patients, Hemodynamics, Bupivacaine
- Being tested
- Low-Dose Hyperbaric Bupivacaine, Standard-Dose Hyperbaric Bupivacaine
- Keywords
- Low-Dose Hyperbaric Bupivacaine, Standard-Dose Hyperbaric Bupivacaine, Spinal Anesthesia, Geriatric Anesthesia, Lower Limb Orthopedic Surgery, Hemodynamic Stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose Hyperbaric BupivacaineDrug
Low-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.
Standard-Dose Hyperbaric BupivacaineDrug
Standard-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Hyperbaric Bupivacaine | Experimental | Participants randomized to this group will receive low-dose hyperbaric bupivacaine for spinal anesthesia before elective lower limb orthopedic surgery. Hemodynamic parameters and postoperative recovery outcomes will be assessed according to the study protocol. Receives: Drug: Low-Dose Hyperbaric Bupivacaine |
| Standard-Dose Hyperbaric Bupivacaine | Active comparator | Participants randomized to this group will receive standard-dose hyperbaric bupivacaine for spinal anesthesia before elective lower limb orthopedic surgery. Hemodynamic parameters and postoperative recovery outcomes will be assessed according to the study protocol. Receives: Drug: Standard-Dose Hyperbaric Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Intraoperative Hypotension
Occurrence of intraoperative hypotension following spinal anesthesia, defined as a decrease in systolic blood pressure greater than 20% from baseline or systolic blood pressure less than 90 mmHg requiring intervention.
Measured: From administration of spinal anesthesia until completion of surgery
Secondary outcomes (4)
Incidence of Intraoperative Bradycardia
Occurrence of intraoperative bradycardia, defined as heart rate less than 50 beats per minute requiring pharmacological treatment.
Measured: From administration of spinal anesthesia until completion of surgery.
Time to Complete Motor Recovery
Time required to achieve complete motor recovery following spinal anesthesia, assessed using Bromage Score 0.
Measured: From completion of surgery until achievement of Bromage Score 0, assessed up to 24 hours postoperatively
Time to First Ambulation
Time from completion of surgery to the patient's first assisted ambulation.
Measured: Within the first 24 hours after surgery
Postoperative Recovery Profile
Assessment of recovery following spinal anesthesia, including readiness for discharge from the post-anesthesia care unit and return of motor function.
Measured: From completion of surgery until discharge from the post-anesthesia care unit (PACU), assessed up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, SpinalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomized into two parallel groups. One group will receive low-dose hyperbaric bupivacaine and the other will receive standard-dose hyperbaric bupivacaine for spinal anesthesia. Outcomes related to hemodynamic stability and postoperative recovery will be compared between groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Hospital Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Shaheryar Bashir, Mayo Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684989
- Sponsor's protocol ID
- Mayo_ANS_01
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) collected during this study will not be made publicly available. Participant confidentiality and privacy will be maintained in accordance with institutional ethical guidelines and the approved study protocol. Aggregate study results may be published or presented, but individual-level data will not be shared outside the research team.
Publications
Lee YY, Ngan Kee WD, Muchhal K, Chan CK. Clinical comparison of 12 mg ropivacaine and 8 mg bupivacaine (with fentanyl) in spinal anaesthesia for major orthopaedic surgery in geriatric patients. Acta Anaesthesiol Scand. 2011;55(3):298-303
Ben-David B, Frankel R, Arzumonov T, Marchevsky Y, Volpin G. Minidose bupivacaine-fentanyl spinal anesthesia for surgical repair of hip fracture in the aged. Anesthesiology. 2000 Jan;92(1):6-10. doi: 10.1097/00000542-200001000-00007.
PubMed 10638892Patel A, Yadav AK, Patel PS, Kumari R, Deepesh. Comparative hemodynamic stability in low-dose versus conventional-dose bupivacaine for spinal anaesthesia in elderly patients. Int J Pharm Res Technol. 2025;15(2). doi:10.31838/ijprt/15.2.89.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Low-Dose Versus Standard-Dose Hyperbaric Bupivacaine in Spinal Anesthesia: Hemodynamic Stability and Recovery Profile in Elderly Patients Undergoing Lower Limb Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT07684989
- Acronym / sponsor ID
- Mayo_ANS_01
- Conditions
- Anesthesia, Spinal, Orthopedic Procedures, Postoperative Recovery in Elderly Patients, Hemodynamics, Bupivacaine
- Keywords
- Low-Dose Hyperbaric Bupivacaine, Standard-Dose Hyperbaric Bupivacaine, Spinal Anesthesia, Geriatric Anesthesia, Lower Limb Orthopedic Surgery, Hemodynamic Stability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Mayo Hospital LahoreUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Jul 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.
The goal of this randomized controlled trial is to determine whether low-dose hyperbaric bupivacaine provides better hemodynamic stability and postoperative recovery compared with standard-dose hyperbaric bupivacaine in elderly patients undergoing lower limb orthopedic surgery under spinal anesthesia.
The main questions it aims to answer are:
- Does low-dose hyperbaric bupivacaine reduce the incidence of intraoperative hypotension and bradycardia compared with standard-dose hyperbaric bupivacaine?
- Does low-dose hyperbaric bupivacaine improve postoperative recovery profile compared with standard-dose hyperbaric bupivacaine?
Researchers will compare elderly patients receiving low-dose hyperbaric bupivacaine with those receiving standard-dose hyperbaric bupivacaine to determine whether a lower intrathecal dose improves cardiovascular stability and recovery without compromising the effectiveness of spinal anesthesia.
Participants will:
- Provide written informed consent before enrollment.
- Undergo elective lower limb orthopedic surgery under spinal anesthesia.
- Be randomly assigned to receive either low-dose or standard-dose hyperbaric bupivacaine.
- Have their blood pressure, heart rate, and other vital signs monitored throughout the surgical procedure.
- Be assessed for intraoperative hypotension and bradycardia according to predefined study criteria.
- Be evaluated for postoperative recovery parameters, including motor recovery and readiness for postoperative recovery and mobilization.
The information obtained from this study may help identify a safer and more effective spinal anesthetic technique for elderly patients undergoing orthopedic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomized into two parallel groups. One group will receive low-dose hyperbaric bupivacaine and the other will receive standard-dose hyperbaric bupivacaine for spinal anesthesia. Outcomes related to hemodynamic stability and postoperative recovery will be compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Hyperbaric Bupivacaine | Experimental | Drug: Low-Dose Hyperbaric BupivacaineParticipants randomized to this group will receive low-dose hyperbaric bupivacaine for spinal anesthesia before elective lower limb orthopedic surgery. Hemodynamic parameters and postoperative recovery outcomes will be assessed according to the study protocol. |
| Standard-Dose Hyperbaric Bupivacaine | Active comparator | Drug: Standard-Dose Hyperbaric BupivacaineParticipants randomized to this group will receive standard-dose hyperbaric bupivacaine for spinal anesthesia before elective lower limb orthopedic surgery. Hemodynamic parameters and postoperative recovery outcomes will be assessed according to the study protocol. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Male or female patients aged 65 years and above.
- Patients scheduled for elective lower limb orthopedic surgery under spinal anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Patients willing to participate and provide written informed consent.
Key exclusion criteria (11 listed)
- Refusal to participate in the study.
- Contraindications to spinal anesthesia (e.g., infection at puncture site, coagulopathy, severe hypovolemia, raised intracranial pressure).
- Known hypersensitivity or allergy to bupivacaine.
- Severe valvular heart disease.
- Significant cardiac arrhythmias.
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 |
|---|---|---|
| Low-Dose Hyperbaric BupivacaineLow-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery. | Drug | Low-Dose Hyperbaric Bupivacaine |
| Standard-Dose Hyperbaric BupivacaineStandard-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery. | Drug | Standard-Dose Hyperbaric Bupivacaine |
Primary outcome
Incidence of Intraoperative Hypotension
Time frame: From administration of spinal anesthesia until completion of surgery
Occurrence of intraoperative hypotension following spinal anesthesia, defined as a decrease in systolic blood pressure greater than 20% from baseline or systolic blood pressure less than 90 mmHg requiring intervention.
4 secondary outcomes
Incidence of Intraoperative Bradycardia
Time frame: From administration of spinal anesthesia until completion of surgery.
Time to Complete Motor Recovery
Time frame: From completion of surgery until achievement of Bromage Score 0, assessed up to 24 hours postoperatively
Time to First Ambulation
Time frame: Within the first 24 hours after surgery
Postoperative Recovery Profile
Time frame: From completion of surgery until discharge from the post-anesthesia care unit (PACU), assessed up to 24 hours postoperatively
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 13 Jul 2026.
- BackgroundLee YY, Ngan Kee WD, Muchhal K, Chan CK. Clinical comparison of 12 mg ropivacaine and 8 mg bupivacaine (with fentanyl) in spinal anaesthesia for major orthopaedic surgery in geriatric patients. Acta Anaesthesiol Scand. 2011;55(3):298-303
- Background: PubMed 10638892Ben-David B, Frankel R, Arzumonov T, Marchevsky Y, Volpin G. Minidose bupivacaine-fentanyl spinal anesthesia for surgical repair of hip fracture in the aged. Anesthesiology. 2000 Jan;92(1):6-10. doi: 10.1097/00000542-200001000-00007.
- BackgroundPatel A, Yadav AK, Patel PS, Kumari R, Deepesh. Comparative hemodynamic stability in low-dose versus conventional-dose bupivacaine for spinal anaesthesia in elderly patients. Int J Pharm Res Technol. 2025;15(2). doi:10.31838/ijprt/15.2.89.
- Individual participant dataSharing planned: No. Individual participant data (IPD) collected during this study will not be made publicly available. Participant confidentiality and privacy will be maintained in accordance with institutional ethical guidelines and the approved study protocol. Aggregate study results may be published or presented, but individual-level data will not be shared outside the research team.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low-Dose Hyperbaric Bupivacaine and Standard-Dose Hyperbaric Bupivacaine in people with Anesthesia, Spinal and Orthopedic Procedures, run by Mayo Hospital Lahore 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 4 inclusion and 11 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 13 Jul 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Muhammad Shaheryar Bashir, MBBS, BSc, FCPS (R) CHPE, DPHN (+92-335-4377900, drmsb259@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Intraoperative Hypotension (time frame: From administration of spinal anesthesia until completion of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07684989, which also lists 3 linked publications.
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 13 Jul 2026.