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

NCT07684989 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-07-13

No results posted yet for this study

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

Interventions

DRUG

Low-Dose Hyperbaric Bupivacaine

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

DRUG

Standard-Dose Hyperbaric Bupivacaine

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

Sponsors & Collaborators

  • Mayo Hospital Lahore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07684989 on ClinicalTrials.gov