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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:
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:
The information obtained from this study may help identify a safer and more effective spinal anesthetic technique for elderly patients undergoing orthopedic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Dose Hyperbaric Bupivacaine | Drug | Low-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Shaheryar Bashir, MBBS, BSc, FCPS (R) CHPE, DPHN | Contact | +92-335-4377900 | drmsb259@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Hospital, Lahore | Lahore | Punjab Province | 54950 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 10638892 | 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. | |
| 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. |
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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.
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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.
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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.
| Standard-Dose Hyperbaric Bupivacaine | Drug | Standard-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery. |
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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 |