Comparison of Low-Dose Versus Standard-Dose Hyperbaric Bupivacaine in Spinal Anesthesia
10 juli 2026 uppdaterad av: Muhammad Shaheryar Bashir, Mayo Hospital Lahore
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
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
180
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Muhammad Shaheryar Bashir, MBBS, BSc, FCPS (R) CHPE, DPHN
- Telefonnummer: +92-335-4377900
- E-post: drmsb259@gmail.com
Studieorter
-
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54950
- Mayo Hospital, Lahore
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Low-Dose Hyperbaric Bupivacaine
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.
|
Low-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.
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Aktiv komparator: Standard-Dose Hyperbaric Bupivacaine
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.
|
Standard-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Intraoperative Hypotension
Tidsram: From administration of spinal anesthesia until completion of surgery
|
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.
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From administration of spinal anesthesia until completion of surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Intraoperative Bradycardia
Tidsram: From administration of spinal anesthesia until completion of surgery.
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Occurrence of intraoperative bradycardia, defined as heart rate less than 50 beats per minute requiring pharmacological treatment.
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From administration of spinal anesthesia until completion of surgery.
|
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Time to Complete Motor Recovery
Tidsram: From completion of surgery until achievement of Bromage Score 0, assessed up to 24 hours postoperatively
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Time required to achieve complete motor recovery following spinal anesthesia, assessed using Bromage Score 0.
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From completion of surgery until achievement of Bromage Score 0, assessed up to 24 hours postoperatively
|
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Time to First Ambulation
Tidsram: Within the first 24 hours after surgery
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Time from completion of surgery to the patient's first assisted ambulation.
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Within the first 24 hours after surgery
|
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Postoperative Recovery Profile
Tidsram: From completion of surgery until discharge from the post-anesthesia care unit (PACU), assessed up to 24 hours postoperatively
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Assessment of recovery following spinal anesthesia, including readiness for discharge from the post-anesthesia care unit and return of motor function.
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From completion of surgery until discharge from the post-anesthesia care unit (PACU), assessed up to 24 hours postoperatively
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
30 juni 2027
Avslutad studie (Beräknad)
30 juni 2027
Studieregistreringsdatum
Först inskickad
24 juni 2026
Först inskickad som uppfyllde QC-kriterierna
29 juni 2026
Första postat (Faktisk)
6 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Mayo_ANS_01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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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