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

Phase 4Not Yet RecruitingNCT07684989

Mayo Hospital Lahore180 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

180

Conditions

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Incidence of Intraoperative Bradycardia

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

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