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A study to compare hyperbaric ropivacaine and hyperbaric levobupivacaine in spinal anesthesia for below umbilical level surgeries

A comparative assessment of effects of hyperbaric ropivacaine and hyperbaric levobupivacaine in spinal anesthesia for infraumbilical surgeries: A Randomized Clinical Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078173
Enrollment
80
Registered
2024-12-16
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: M220- Recurrent dislocation of patella Health Condition 2: N40-N53- Diseases of male genital organs Health Condition 3: K35-K38- Diseases of appendix Health Condition 4: K40-K46- Hernia Health Condition 5: N20-N23- Urolithiasis Health Condition 6: N70-N77- Inflammatory diseases of female pelvic organs Health Condition 7: N80-N98- Noninflammatory disorders of female genital tract

Interventions

Intervention1: Ropivacaine heavy: clinical efficacy and safety in patients undergoing infraumbilical surgeries.Total duration of study is till the time when motor block returns to modified bromage 4 C

Sponsors

Piduru Nishma
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients undergoing infraumbilical surgeries under spinal anesthesia(gynecological, urological and lower limb surgeries) 2.Patients of American Society Of Anesthesiologists (ASA) Physical grade I or II

Exclusion criteria

Exclusion criteria: 1.Pregnancy 2.Uncooperative patient and patient refusal 3.Patients with history of allergy to the study drugs 4.Patients with uncontrolled diabetes, uncontrolled hypertension, uncontrolled thyroid disorder. 5.Patients with cardiovascular, respiratory, renal, hepatic and neurological diseases. 6.Patients contraindicated for spinal anesthesia: i.Local site infection ii.Spinal deformity iii.Patients with bleeding disorders

Design outcomes

Primary

MeasureTime frame
Quality of surgical anesthesia (excellent, satisfactory, inadequate, failure).Timepoint: Baseline, every 2 minutes for first 10 minutes, every 5 minutes till 30 minutes, every 10 minutes till 60 minutes and every 30 minutes till discharge from recovery room.

Secondary

MeasureTime frame
Sensory block characteristics( sensory onset time, time to adequate block level t6 or t4, maximum sensory block level, time to peak sensory block level, time to two segment regression. Motor block characteristics( time to onset of motor block, time to reach modified bromage 4, duration of motor blockade. Hemodynamic parameters(SBP,DBP,MAP,HR). Side effects(hypotension, bradycardia, nausea, others).Timepoint: Baseline, every 2 minutes for first 10 minutes, every 5 minutes till 30 minutes, every 10 minutes till 60 minutes and every 30 minutes till discharge from recovery room.

Countries

India

Contacts

Public ContactPIDURU NISHMA

Regional Institute of Medical Sciences, Imphal, Manipur

gojendrar68@gmail.com9862824562

Outcome results

None listed

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