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Comparison of two different concentrations of an analgesic drug to establish that lower concentrations are sufficient to provide similar pain relief

Comparison of the analgesic effect of 0.125% and 0.25% Levobupivacaine combined with Dexmedetomidine as an adjuvant for Transversus Abdominis Plane (TAP) block in children aged 2 7 years undergoing unilateral inguinal herniotomy- A Non Inferiority Randomised Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/081805
Enrollment
58
Registered
2025-03-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention1: Lower concentration of Levobupivacaine with Dexmedetomidine: Under General anaesthesia, before incision, 0.5 ml/kg of 0.125% Levobupivacaine with 1 mcg/kg of Dexmedetomidine will be giv

Sponsors

All India Institute of Medical Sciences, Bibinagar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 2-7 years 2.ASA I and II 3.Unilateral Inguinal herniotomies

Exclusion criteria

Exclusion criteria: 1. Allergies to study medication 2.History of significant cardiovascular or neurological disorders 3.Contraindications to regional anesthesia.

Design outcomes

Primary

MeasureTime frame
Pain scores (using FLACC scale) 2nd hourly for first 6 hours and 6th hourly for 24 hoursTimepoint: 2,4,6,12,18,24 hours after giving Transversus Abdominis Plane block—

Secondary

MeasureTime frame
1. Duration of analgesia (time from completion of TAP block to the first dose of rescue analgesia). 2. Incision response and response to surgical stress measured intraoperatively by hemodynamic parameters like NIBP, HR. Timepoint: 1.Time to first rescue analgesia 2.NIBP,HR measured every 5 mins for first 30 mins and then every 10 mins till the end of surgery—

Countries

India

Contacts

Public ContactD Ragha Renuka

All India Institute of Medical Sciences

ragha345@gmail.com8143701255

Outcome results

None listed

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