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:

• 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 Overview

• Status: Not yet recruiting
• Conditions: Orthopedic Procedures; Hemodynamics; Anesthesia, Spinal; Bupivacaine; Postoperative Recovery in Elderly Patients
• Intervention / Treatment: Drug: Low-Dose Hyperbaric Bupivacaine; Drug: Standard-Dose Hyperbaric Bupivacaine

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Muhammad Shaheryar Bashir, MBBS, BSc, FCPS (R) CHPE, DPHN; Phone Number: +92-335-4377900; Email: drmsb259@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54950
      • Mayo Hospital, Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-Dose Hyperbaric Bupivacaine; 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.	Drug: Low-Dose Hyperbaric Bupivacaine; Low-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.
Active Comparator: Standard-Dose Hyperbaric Bupivacaine; 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.	Drug: Standard-Dose Hyperbaric Bupivacaine; Standard-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From administration of spinal anesthesia until completion of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Intraoperative Bradycardia	Occurrence of intraoperative bradycardia, defined as heart rate less than 50 beats per minute requiring pharmacological treatment.	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.	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.	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.	From completion of surgery until discharge from the post-anesthesia care unit (PACU), assessed up to 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Holy Family Hospital, Pakistan

Publications and helpful links

General 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.
• Patel 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 record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Spinal Anesthesia; Hemodynamic Stability; Geriatric Anesthesia; Low-Dose Hyperbaric Bupivacaine; Standard-Dose Hyperbaric Bupivacaine; Lower Limb Orthopedic Surgery
• Other Study ID Numbers: Mayo1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No