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NCT Number: NCT07684989

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

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.

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Key information

Conditions

Anesthesia, Spinal Bupivacaine Hemodynamics Orthopedic Procedures Postoperative Recovery in Elderly Patients

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Hospital, Lahore

Lahore, Punjab Province, 54950, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-Dose Hyperbaric Bupivacaine

Drug

Low-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.

Standard-Dose Hyperbaric Bupivacaine

Drug

Standard-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of Intraoperative Bradycardia

    Time frame: From administration of spinal anesthesia until completion of surgery.

    Occurrence of intraoperative bradycardia, defined as heart rate less than 50 beats per minute requiring pharmacological treatment.

  2. Time to Complete Motor Recovery

    Time frame: From completion of surgery until achievement of Bromage Score 0, assessed up to 24 hours postoperatively

    Time required to achieve complete motor recovery following spinal anesthesia, assessed using Bromage Score 0.

  3. Time to First Ambulation

    Time frame: Within the first 24 hours after surgery

    Time from completion of surgery to the patient's first assisted ambulation.

  4. Postoperative Recovery Profile

    Time frame: From completion of surgery until discharge from the post-anesthesia care unit (PACU), assessed up to 24 hours postoperatively

    Assessment of recovery following spinal anesthesia, including readiness for discharge from the post-anesthesia care unit and return of motor function.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+92-335-4377900

Sponsors and collaborators

Lead sponsor

Mayo Hospital Lahore

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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