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"Study to Compare the Effectiveness of High versus Low doses of Intrathecal Hyperbaric Bupivacaine given at different time intervals for inguinal hernia surgeries"

"A Prospective Randomized Study to Compare the Effectiveness of High versus Low doses of Intrathecal Hyperbaric Bupivacaine given at different time intervals for inguinal hernia surgeries"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/037984
Enrollment
90
Registered
2021-11-12
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: K402- Bilateral inguinal hernia, withoutobstruction or gangrene

Interventions

Intervention1: High doses of Intrathecal Hyperbaric Bupivacaine: Group H1-10 mg of hyperbaric bupivacaine 0.5% in 2ml volume intrathecally in sitting position and will remain in this position for 1 mi

Sponsors

Teerthanker Mahaveer Medical College and Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.American society of Anaesthesiologists(ASA) physical status I, II scheduled for inguinal hernia surgery under spinal anaesthesia. 2.Patient between age group of 18 to 65 years of either sex. 3.Patient with BMI of 18.5-22.9 kg/m2

Exclusion criteria

Exclusion criteria: 1.Patient refusal for procedure. 2.Patient with neurological diseases. 3.Patient with spine abnormalities. 4.Patient with renal, hepatic, cardiac and pulmonary diseases. 5.Patient with intracranial hypertension, major bleeding disorder, patients on anticoagulant, local infection and allergic reaction to local anaesthetics.

Design outcomes

Primary

MeasureTime frame
1. To assess the effectiveness at 1 minute sitting position with high dose of Intrathecal Hyperbaric Bupivacaine. 2.To assess the effectiveness at 2 minute sitting position with high dose of Intrathecal Hyperbaric Bupivacaine. 3.To assess the effectiveness at immediately lying down position with low dose of Intrathecal Hyperbaric Bupivacaine. 4.To compare the effectiveness at 1 and 2 minutes sitting position with high doses of Intrathecal Hyperbaric Bupivacaine versus immediately lying down with low dose of Intrathecal Hyperbaric Bupivacaine. 5.To assess and compare Block Characteristics, Haemodynamic parameters and Complications/Side-effects between the study groups. Timepoint: To assess Haemodynamic parameters at every 5 minutes for the first 30 minutes of surgery and then every 10 minutes till completion of surgery

Secondary

MeasureTime frame
1.To compare the effectiveness at 1 and 2 minutes sitting position with high doses of Intrathecal Hyperbaric Bupivacaine versus immediately lying down with low dose of Intrathecal Hyperbaric Bupivacaine. 2.To assess and compare Block Characteristics, Haemodynamic parameters and Complications/Side-effects between the study groups. Timepoint: To assess Haemodynamic parameters at every 5 minutes for the first 30 minutes of surgery and then every 10 minutes till completion of surgery

Countries

India

Contacts

Public ContactDr Nitish Singh

Teerthanker Mahaveer Medical College and Research Centre

rohitmaxy@gmail.com9897490444

Outcome results

None listed

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