Comparative Study of 0.5 percent Hyperbaric Levobupivacaine Plain versus 0.5 percent Hyperbaric Levobupivacaine with Intrathecal Fentanyl for Spinal Anesthesia in Infra-Umbilical Surgeries

A study to compare the effects of 0.5 percent Hyperbaric levobupivacaine plain vs 0.5 percent Hyperbaric levobupivacaine with intrathecal Fentanyl for spinal anaesthesia in infra umbilical surgeries - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078360

Enrollment

Registered

2024-12-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Interventions

Intervention1: Hyperbaric levobupivacaine: Dose is 0.5 percent Hyperbaric Levobupivacaine 3ml with 0.5ml normal saline total 3.5ml Route of administration is intrathecal administration. Control Interv

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patient willing to sign the written & informed consent. 2) Patients belonging to American Society of anesthesiologists grade I, II amd III 3) Patients with no history of allergy to opiods will be selected for the study. 4) Patients posted for infraumbilical surgeries.

Exclusion criteria

Exclusion criteria: 1) Patient’s refusal from taking part in the study. 2) Patients who have used any opioid or sedative medications in the week prior to surgery 3) Patients having history of drug abuse in the past. 4) Patient who have history of allergic reactions to bupivacaine or fentanyl. 5) Patient who have contraindication to spinal anaesthesia (e.g., coagulation defects, infection at puncture site, pre-existing neurological deficits in the lower extremities), and cardiovascular, respiratory, neurological, psychological, hepatic, or renal disease.

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of intrathecal fentanyl as an adjuvant to hyperbaric 0.5 percent levobupivacaine and hyperbaric 0.5 percent levobupivacaine alone in onset and prolonging effects of spinal and motor block , hemodynamic stability, effect on duration of anaesthesia and post operative analesgia in patients receiving spinal anaesthesia in infra umbilical surgeries. Timepoint: 0 minute 2 minutes 4 minutes 6 minutes 8 minutes 10 minutes 20 minutes 30 minutes 40 minutes 60 minutes 90 minutes 120 minutes	—

Measure

Time frame

To compare the efficacy of intrathecal fentanyl as an adjuvant to hyperbaric 0.5 percent levobupivacaine and hyperbaric 0.5 percent levobupivacaine alone in onset and prolonging effects of spinal and motor block , hemodynamic stability, effect on duration of anaesthesia and post operative analesgia in patients receiving spinal anaesthesia in infra umbilical surgeries. Timepoint: 0 minute 2 minutes 4 minutes 6 minutes 8 minutes 10 minutes 20 minutes 30 minutes 40 minutes 60 minutes 90 minutes 120 minutes

—

Secondary

Measure	Time frame
To Assess VAS Score , Duration of Absolute & effective analgesia, number of rescue analgesia required in 24 hrs & post operative complication if any Timepoint: 24 hrs	—

Countries

India

Contacts

Public ContactDr Dinesh Chauhan

Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre

drdinesh77@gmail.com9099014672

Outcome results

None listed

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