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Comparison the efficacy of 0.5 % hyperbaric levobupivacaine with 0.5% levobupivacaine plus fentanyl in lower limb orthopaedics surgery under spinal anaesthesia.

Comparison of 0.5% hyperbaric levobupivacaine with 0.5% hyperbaric levobupivacaine plus fentanyl in lower limb orthopaedic surgery under spinal anaesthesia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049704
Enrollment
100
Registered
2023-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: M236- Other spontaneous disruption of ligament(s) of knee

Interventions

Intervention1: levobupivacaine: levobupivacaine plus fentanyl Control Intervention1: 0.5% hyperbaric levobupivacaine: levobupivacaine , a pure (-) enantiomer of racemic bupivacaine and has low cardiot

Sponsors

Mandakini katiyar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA GRADE 1 AND 2. SCHEDULED FOR ELECTIVE LOWER LIMB ORTHOPAEDICS SURGERIES UNDER SPINAL ANAESTHESIA.

Exclusion criteria

Exclusion criteria: 1. LACK OF PATIENTS CONSENT. 2. PATIENT REFUSALFOR SPINAL ANESTHESIA. 3.HISTORY OF SERIOUS PULMONARY DISEASE,ISCHEMIC HEART DISEASE,RENAL/HEPATIC DYSFUNCTION ,CORONARY ARTERY,OR CERVICAL SPINE DISEASE AND PATIENTS WITH ABNORMAL COAGULATION PROFILE. 4. PATIENTS WITH LOCAL SKIN SITE INFECTION. 5.PATIENTS WITH HYPERSENSTIVITY TO ANY OF THE DRUGS USED. 6.PREGNANT AND LACTATING MOTHERS.

Design outcomes

Primary

MeasureTime frame
â??To study and compare the onset of analgesia, duration of sensory blockade , motor blockade, hemodynamics parameters ( SBP,DBP,MAP,HR) of 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric levobupivacaine with fentanyl. Timepoint: first 24 hour at immediately after block,at 5min,10min,15min,20 min,25min ,30 min,60 min,90min,120 min,180 min,240 min ,300min.—

Secondary

MeasureTime frame
to compare the side effects of 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric levobupivacaine with fentanyl. Timepoint: first 24 hour at immediately after block,at 5min,10min,15min,20 min,25min ,30 min,60 min,90min,120 min,180 min,240 min ,300min.—

Countries

India

Contacts

Public ContactDrMandakini katiyar

peoples college of medical sciences and research center.bhanpur bhopal

ph.anaesthsia@peoplesuniversity.edu.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026