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Comparision of two drugs used in spinal anaesthesia named as hyperbaric Levobupivacaine (fixed dose combination) and Fentanyl versus hyperbaric Levobupivacaine (reconstituted ) and Fentanyl in patients undergoing surgeries below level of umbilicus

Comparative evaluation of intrathecal anaesthesia with hyperbaric (0.5%)Levobupivacaine (FDC-fixed dose combination)with Fentanyl and hyperbaric (0.5%) Levobupivacaine (reconstituted )with Fentanyl in patients undergoing infra-umbilical surgeries - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049684
Enrollment
132
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: S399- Unspecified injury of abdomen, lower back, pelvis and external genitals

Interventions

Intervention1: hyperbaric (0.5%)Levobupivacaine (FDC-fixed dose combination)with Fantanyl: Spinal anaesthesia given through intrathecal route given once before start of surgical procedure with hyperb

Sponsors

Teerthanker Mahaveer Medical college, Moradabad, Uttar pradesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients of the American Society of Anesthesiologists physical status I and II, scheduled to undergo infra-umbilical surgery under spinal anaesthesia will be select Informed consent

Exclusion criteria

Exclusion criteria: Patients with uncontrolled hypertension, Neurologic disease, left ventricular dysfunction and coagulation Disorders. Pregnancy Hypersensitivity to amide local anesthetics

Design outcomes

Primary

MeasureTime frame
Each participant in the study will be assessed for following Primary outcome parameters are as follows :- 1.Onset of sensory block (min.) 2.Duration of sensory block (min.) 3.Onset time of motor block (min.) 4.Total duration of motor block (min.) 5.Duration of analgesia (min.) Timepoint: 1.Onset of sensory block (min.) -loss of sensation to T-8 level. 2.Duration of sensory block (min.)-complete regression assessed at 3 minutes first 15 min, 5 min for next 30 min, at every 30 min up to 480 minutes. 3.Onset time of motor block (min.) 4.Total duration of motor block (min.) 5.Duration of analgesia (min.):- from onset of sensory block to first request for rescue analgesia Time points data analysis:-1st at 6th month from onset , 2nd at 1 year and 3rd and final at end—

Secondary

MeasureTime frame
Hemodynamics (HR, RR, SBP, DBP, MAP, SP02)Vitals Timepoint: will be monitored every 2 mins up to 15mins and thereafter every 5 mins until the completion of surgery—

Countries

India

Contacts

Public ContactDr Payal Jain

Teerthanker Mahaveer Medical college and research centre,Moradabad , Uttar Pradesh

drgurdeep.medical@tmu.ac.in8218770729

Outcome results

None listed

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