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TO STUDY THE ADVANTAGE OF ADDING DEXMEDETOMIDINE FOR NERVE BLOCK IN PATIENTS UNDERGOING CLEFT PALATE REPAIR

A PROSPECTIVE RANDOMISED DOUBLE BLINDED STUDY TO COMPARE THE EFFICACY OF BILATERAL SUPRAZYGOMATIC MAXILLARY NERVE BLOCK WITH 0.25% BUPIVACAINE WITH PLACEBO VS 0.25% BUPIVACAINE WITH DEXMEDETOMIDINE FOR PROVIDING POST-OPERATIVE ANALGESIA IN PATIENTS UNDERGOING CLEFT PALATE REPAIR

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027437
Enrollment
64
Registered
2020-08-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: Q37- Cleft palate with cleft lip

Interventions

Intervention1: 0.25% bupivacaine with dexmedetomidine: Suprazygomatic maxillary nerve block using 0.25% bupivacaine with dexmedetomidine Control Intervention1: 0.25% bupivacaine with normal saline: Su

Sponsors

Sri Ramachandra Institute of Higher Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I and II All patients requiring surgery for soft palate cleft or soft and hard palate clefts 5 yrs and younger

Exclusion criteria

Exclusion criteria: Patient refusal Allergy to local anaesthetic agents Patients on anticoagulant or bleeding disorders Infection at the site of injection Injury at the needle entry point Current treatment for pain relief Participation in another clinical trial

Design outcomes

Primary

MeasureTime frame
Time for the first resque analgesia with fentanylTimepoint: Time for the first resque analgesia with fentanyl upto 2hours post of—

Secondary

MeasureTime frame
Total post operative fentanyl consumption for 2 hours Total post operative paracetamol consumption for 24 hours Respiratory and suprazygomatic maxillary nerve block related complicationTimepoint: 24 hours—

Countries

India

Contacts

Public ContactPrabavathi S

Sri Ramachandra Institute of Higher Education and Research

vakamudi@gmail.com9840022626

Outcome results

None listed

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