Comparison of Low-Dose Versus Standard-Dose Hyperbaric Bupivacaine in Spinal Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-Dose Hyperbaric Bupivacaine, Standard-Dose Hyperbaric Bupivacaine.
- Who it may be relevant to
- Registry conditions: Anesthesia, Spinal, Orthopedic Procedures, Postoperative Recovery in Elderly Patients, Hemodynamics. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
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.
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.
Primary outcome measures
- Incidence of Intraoperative Hypotension [Time frame: From administration of spinal anesthesia until completion of surgery]
Secondary outcome measures (4)
- Incidence of Intraoperative Bradycardia [Time frame: From administration of spinal anesthesia until completion of surgery.]
- Time to Complete Motor Recovery [Time frame: From completion of surgery until achievement of Bromage Score 0, assessed up to 24 hours postoperatively]
- Time to First Ambulation [Time frame: Within the first 24 hours after surgery]
- Postoperative Recovery Profile [Time frame: From completion of surgery until discharge from the post-anesthesia care unit (PACU), assessed up to 24 hours postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Mayo Hospital, Lahore — Lahore
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. PMID 10638892
- 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.
Identifiers
NCT: NCT07684989 · Mayo_ANS_01