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Clinical Trials/CTRI/2018/05/013587
CTRI/2018/05/013587CompletedNot Applicable

Comparative Evaluation Of Ultrasound Guided Supra Inguinal Versus Infra Inguinal Approach To Fascia Iliaca Compartment Block – A Randomised Clinical Trial

Mahatma Gandhi Medical College and Research Institute1 site in 1 country60 target enrollmentStarted: May 4, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
2) quadriceps muscle strenght

Study Overview

Brief Summary

Afterobtaining approval from the institutional ethical committee and obtainingpatient consent, 60 patients schedule for lower limb surgeries ( fulfillinginclusion criteria ) will be recruited for this study.

After the initial assessment, patient willbe randomised based on the allocation number using closed envelope technique.Patient will be prepared for the FICB procedure and the distance from supra- inguinaland infra- inguinal injection points from the ligament will be measured usingultrasound.

Patientwill be continuously monitored and hemodynamic parameters recorded every 10 minutes.The motor and sensory  assessment afterthe block, will be done by the examiner blinded to the approach used for FICB. Sensoryassessment will be done at 30, 45 and 60 minutes after block

A successful 3 nerve block is consideredwhen the sensory assessement score for cold sensation is 0 and motor powerscore for quadriceps and adductor muscles is 1-0 and 50% decrease in pressuregenerated by adductor squeeze test at the end of 60 minutes after block.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •ASA I – II 2) All surgeries requiring FICB for analgesia.

Exclusion Criteria

  • •Patient refusal 2) Lower limb fracture 3) Patients allergic to local anaesthetics 4) Patients with coagulopathy 5) Patients with neurological deficits and neuromuscular diseases 6) Patients with infection at the site of injection 7) Pregnant patients.

Outcomes

Primary Outcomes

2) quadriceps muscle strenght

Time Frame: outcome will be assessed every 15 minutes for one hour

Incidence of 3 nerves block -

Time Frame: outcome will be assessed every 15 minutes for one hour

1) sensory Blockade

Time Frame: outcome will be assessed every 15 minutes for one hour

3) adductor squeeze test

Time Frame: outcome will be assessed every 15 minutes for one hour

Secondary Outcomes

  • 1) Time of onset of block of all three nerves(2) Distance between Supra- inguinal and Infra – inguinal injection points from inguinal ligament)

Investigators

Sponsor Class
Private medical college

Study Sites (1)

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