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Spinal Anaesthesia for lower abdominal and lower limb surgeries- Comparison of Heavy formulations of Levobupivacaine, ropivacaine with racemic bupivacaine

Subarachnoid block for elective infraumbilical surgeries- Comparison of hyperbaric solutions of Levobupivacaine and Ropivacaine with Hyperbaric racemic bupivacaine- A randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049556
Enrollment
105
Registered
2023-02-08
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: K353- Acute appendicitis with localizedperitonitis Health Condition 2: K400- Bilateral inguinal hernia, with obstruction, without gangrene Health Condition 3: T79-T79- Certain early complications of trauma Health Condition 4: N40-N53- Diseases of male genital organs Health Condition 5: M22- Disorder of patella Health Condition 6: M65-M67- Disorders of synovium and tendon Health Condition 7: K41- Femoral hernia Health Condition 8: K40-K46- Hernia Health Condition 9: M00-M02- I

Interventions

Intervention1: Hyperbaric 0.5% Levobupivacaine Hydrochloride: Hyperbaric 0.5% Levobupivacaine hydrochloride 2.6 ml with Fentanyl citrate 20 mcg, single neuraxial blockade Intervention2: Hyperbaric 0.7

Sponsors

Dr Juliet Ann Abraham
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I-11 Age 20- 70 years Height 150-180cms Infraumbilical surgeries >2 hours

Exclusion criteria

Exclusion criteria: Patient refusal Local infection Coagulopathies Allergy to the study drugs Any pre-existing neurological deficits Parturients

Design outcomes

Primary

MeasureTime frame
Comparison of onset and duration of motor blockadeTimepoint: The onset of the maximum motor blockade- attaining Grade 4 on the Modified Bromage scale- checked every 3 mins from the time of administration (3 mins, 6 mins, 9 mins, 12 mins) The duration of the motor blockade- from the onset of the motor blockade [(Grade 4 on Modified Bromage scale), peaking at (Modified Bromage scale Grade 1)]till the effect of the drug is completely subsided (Modified Bromage scale Grade 6) - checked every 20 mins post-surgery (20 mins, 40 mins, 60 mins..120mins )

Secondary

MeasureTime frame
1. To compare the onset and duration of sensory blockadeTimepoint: The onset of the sensory blockade - blockade at the level of T10 dermatome - checked every minute from the time of administration of the drug (1 min, 2 min, 3 min, 4 min, 5 min) The duration of the sensory blockade -from the onset of sensory blockade (sensory blockade at T10 dermatomal level) till the requirement of first rescue analgesia (checked every 15 minutes post-op till the 1st hour)- and then every hour till the first 6 hours- 2nd hr, 3rd hr... 6th hour);Comparison of intraoperative hemodynamic profile and occurrence of adverse effects with each study drugTimepoint: Vitals are recorded every two minutes from the time of administration of the drug (0 min, 2 mins, 4 mins...) for the first 20 minutes and then every 5 minutes till the end of the surgical procedure. The adverse effects of each drug are duly noted.;To compare the total consumption of rescue analgesia when the comparator agent and interventional agents are administeredTimepoint: The total consumption of rescue analgesia is determined by the need for intravenous analgesics for the first 6 hours post-surgery (1st hour, 2nd hr...6th hour)

Countries

India

Contacts

Public ContactDr Sam Philip

MOSC Medical College Hospital, Kolenchery

drsam_p@hotmail.com9447209010

Outcome results

None listed

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