Comparative Study of Intrathecal Hyperbaric Levobupivacaine Alone Versus Combined Hyperbaric and Isobaric Levobupivacaine on Blood Pressure and Nerve Block in Lower Abdominal Surgery.

Effect of Intrathecal Injection of 0.5 PERCENTAGE Hyperbaric Levobupivacaine Versus a Combination of 0.5 PERCENTAGE Hyperbaric and 0.5 PERCENTAGE Isobaric Levobupivacaine on Post-Spinal Hypotension and Block Characteristics in Patients Undergoing Lower Abdominal Surgery- A Double-Blinded Randomized Controlled?Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093750

Enrollment

Registered

2025-08-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: - Health Condition 2: M958- Other specified acquired deformities of musculoskeletal system

Interventions

Intervention1: 0.5 percentage hyperbaric and 0.5 percentage isobaric levobupivacaine: intrathecal injection of 0.5 percentage hyperbaric and 0.5 percentage isobaric levobupivacaine on post spinal hypo

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients undergoing lower abdominal surgery under spinal anaesthesia of either gender 2.Age 18 ? 70 years 3.American Society of Anesthesiologists classification I ? II

Exclusion criteria

Exclusion criteria: 1.contraindications for neuraxial anesthesia include local sepsis, coagulopathy, increased intracranial pressure, and spinal deformity 2.Patients having Heart rate 3.Patients allergic to study drugs 4.Severe valvular stenotic lesion sepsis, 5.Patients with preexisting Neurological or neuromuscular diseases,Pregnant women

Design outcomes

Primary

Measure	Time frame
Primary objective: To compare the incidence of post-spinal hypotension in patients receiving intrathecal 0.5 % hyperbaric levobupivacaine versus the combination of intrathecal 0.5% hyperbaric and 0.5% isobaric levobupivacaine in patients undergoing lower abdominal surgery under spinal anesthesia.Timepoint: Hypotension measured in every 2 mins for 20 mins and every 15 mins till the end of surgery	—

Secondary

Measure	Time frame
1. To assess other hemodynamic parameters (HR, SBP, DBP, MAP) between both groups at different time intervals 2. To calculate the dose of vasopressors required in each group 8 3. To assess block characteristics. 4. Time to 1 st analgesic requirement postoperatively in both groups 5. To note complications in both groupsTimepoint: The sensory level will be assessed every 15 mins until 2 segment regression is achieved.Time to motor function recovery is also assessed .	—

Measure

Time frame

1. To assess other hemodynamic parameters (HR, SBP, DBP, MAP) between both groups at different time intervals 2. To calculate the dose of vasopressors required in each group 8 3. To assess block characteristics. 4. Time to 1 st analgesic requirement postoperatively in both groups 5. To note complications in both groupsTimepoint: The sensory level will be assessed every 15 mins until 2 segment regression is achieved.Time to motor function recovery is also assessed .

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Countries

India

Contacts

Public ContactPRIYADHARSHINI S

Pondicherry Institute of Medical Sciences

siva85dr@gmail.com9944060676

Outcome results

None listed

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