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Clinical Trials/CTRI/2024/04/066145
CTRI/2024/04/066145CompletedPhase 3

Effect of ultrasound guided Pterygopalatine fossa block on postoperative pain relief in paediatric adenotonsillectomy surgeries under general anaesthesia A Randomized controlled study

Bangalore Medical College and Research Institute1 site in 1 country60 target enrollmentStarted: May 1, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To compare the total analgesic requirements in first 24 hrs postoperatively among the patients with and without Pterygopalatine fossa block

Study Overview

Brief Summary

This study is to assess the effect of Pterygopalatine fossa block by ultrasound guided technique on postoperative analgesic requirements in 24 hours and also assessing intraoperative haemodynamic changes and comparing with the control group patients without the Pterygopalatine fossa block.As systemic analgesics are insufficient to control post adenotonsillectomy pain,regional anaesthetic technique using local anaesthetics are an option and offer advantages over standard approaches.Ultrasound guided suprazygomatic approach to the maxillary nerve in the Pterygopalatine fossa seems to be the safest in children

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
6.00 Year(s) to 16.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Age 6 to 16 years 2.Patients belongs to ASA grade 1,2 3.Patients posted for elective adenotonsillectomy surgeries who are willing to give informed consent.

Exclusion Criteria

  • 1.Parents/caregivers refusal 2.Patients belongs to ASA grade 3,4 3.Hypersensitivity to Local anaesthetics 4.Any history of developmental delay, bleeding diathesis,mental retardation,upper or lower respiratory tract infections,skin lesions,wounds at the puncture site of block.

Outcomes

Primary Outcomes

To compare the total analgesic requirements in first 24 hrs postoperatively among the patients with and without Pterygopalatine fossa block

Time Frame: 24 hours

Secondary Outcomes

  • To assess the time for first rescue analgesia, intraoperative haemodynamic changes and incidence of any complications among the patients with and without Pterygopalatine fossa block(24 hours)

Investigators

Sponsor
Bangalore Medical College and Research Institute
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Akalya K

Bangalore Medical College and Research Institute

Study Sites (1)

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