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

NCT07684989 | Not Yet Recruiting Phase 4

• 1 other identifier: Mayo_ANS_01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of Intraoperative Bradycardia

  From administration of spinal anesthesia until completion of surgery.

• Time to Complete Motor Recovery

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

• Time to First Ambulation

  Within the first 24 hours after surgery

• Postoperative Recovery Profile

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

Study Arms (2)

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.

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.

Drug: Standard-Dose Hyperbaric Bupivacaine

Interventions

Low-Dose Hyperbaric Bupivacaine DRUG

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

Low-Dose Hyperbaric Bupivacaine

Standard-Dose Hyperbaric Bupivacaine DRUG

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

Standard-Dose Hyperbaric Bupivacaine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Hospital Lahore: lead

Study Sites (1)

Mayo Hospital, Lahore

Lahore, Punjab Province, 54950, Pakistan

Location

Related Publications (3)

• 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

  BACKGROUND

• 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.

  PMID: 10638892 BACKGROUND

• 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.

  BACKGROUND

Central Study Contacts

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

CONTACT

+92-335-4377900; drmsb259@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be unaware of the group allocation. Postoperative outcome assessment and data collection will be performed by an investigator blinded to treatment allocation. The anesthesiologist administering spinal anesthesia will not be blinded because of the preparation and administration of different doses of hyperbaric bupivacaine.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)