Evaluation of drugs hyperbaric levobupivacaine versus hyperbaric bupivacaine for elective infra umbilical surgeries under spinal anaesthesia.

A Comparative evaluation of hyperbaric levobupivacaine versus hyperbaric bupivacaine for elective infra umbilical surgeries under spinal anaesthesia.A randomized trial. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086968

Enrollment

Registered

2025-05-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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: elective infra-umbilical surgeries under spinal anesthesia: Patient Group L will receive intrathecal(Subarachnoid block) dose of 15mg (3 ml) of 0.5% hyperbaric levobupivacaine. observat

Eligibility

Inclusion criteria

Inclusion criteria: a) Patients of the American Society of Anesthesiologists I, II, and III. b) Weight 40-80 kg c) Elective infra-umbilical surgeries of approximately 2 hrs. d) Patients who have given informed written consent.

Exclusion criteria

Exclusion criteria: a) Patient refusal. b) Infection. c) Coagulopathy. d) LSCS. e) Spinal deformity. f) Patients of American Society of Anesthesiologists IV. g) Allergic to local anesthetic drugs. h) H/O seizures and neurological deficit. i) Severe renal, hepatic, respiratory and cardiovascular disease. j) Lack of informed written consent.

Design outcomes

Primary

Measure	Time frame
To determine the time to onset of sensory block, time to peak sensory block and duration of sensory block.Timepoint: Time to onset of sensory and motor block after giving drug. Time of duration of sensory and motor block till the next 24 hours and intraoperative hemodynamic monitoring every 1,3,5,10,15 mins and then every 15mins for the next 2 hours.	—

Secondary

Measure	Time frame
(a) To determine the time to onset of sensory block, time to peak sensory block & duration of sensory block. (b) To determine the time to complete motor block & duration of motor block. (c) To determine the duration of analgesia. (d) Intraoperative haemodynamics. (e) Postoperative recovery profile. (f) Complications (If Any )Timepoint: Time to onset of sensory & motor block after giving drug. Time of duration of sensory & motor block till the next 24 hours & intraoperative hemodynamic monitoring every 1,3,5,10,15 mins & then every 15mins for the next 2 hours.	—

Measure

Time frame

(a) To determine the time to onset of sensory block, time to peak sensory block & duration of sensory block. (b) To determine the time to complete motor block & duration of motor block. (c) To determine the duration of analgesia. (d) Intraoperative haemodynamics. (e) Postoperative recovery profile. (f) Complications (If Any )Timepoint: Time to onset of sensory & motor block after giving drug. Time of duration of sensory & motor block till the next 24 hours & intraoperative hemodynamic monitoring every 1,3,5,10,15 mins & then every 15mins for the next 2 hours.

—

Countries

India

Contacts

Public ContactDr Suhas Kumar Mall

All India Institute of Medical Sciences. Gorakhpur.

drsuhasmall@gmail.com8238038707

Outcome results

None listed

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