Not Yet RecruitingPhase 4

Comparison of Low-Dose Versus Standard-Dose Hyperbaric Bupivacaine in Spinal Anesthesia

Pakistan180 participantsStarted 2026-07-01

Plain-language 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. 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Intraoperative Hypotension

Timeframe: From administration of spinal anesthesia until completion of surgery

Trial details

NCT IDNCT07684989

SponsorMayo Hospital Lahore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Muhammad Shaheryar Bashir, MBBS, BSc, FCPS (R) CHPE, DPHN

+92-335-4377900 drmsb259@gmail.com

View on ClinicalTrials.gov More Anesthesia, Spinal trials