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A Study Comparing Two Nerve Block Techniques Used to Reduce Pain among Patients with Thigh Bone Fracture While Being Positioned for Spinal Anaesthesia

Phase 4
Completed
Conditions
Administration,
Registration Number
CTRI/2021/07/034977
Lead Sponsor
Dr Anirudh Pai P
Brief Summary

Patients with proximal femur fractures undergoing surgical treatment for the same are usually operated under subarachnoid block. Positioning for the subarachnoid block can be painful. The purpose of this study is to compare ultrasound-guided fascia iliaca compartment block and ultrasound-guided femoral nerve block, which will be given prior to positioning of patients with a proximal femur fracture, for subarachnoid block, which will alleviate the pain during positioning.



Null hypothesis: There is no difference in outcomes between ultrasound-guided fascia iliaca compartment block and ultrasound-guided femoral nerve block.



Alternative hypothesis: There is a difference in outcomes between ultrasound-guided fascia iliaca compartment block and ultrasound-guided femoral neve block.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
60
Inclusion Criteria
  • Patients belonging to Americal Society of Anesthesiologists Physical Status I, II and III.
  • All patients undergoing surgery for proximal femur fracture under spinal anaesthesia.
Exclusion Criteria
  • Patient refusal.
  • Subjects with allergy to the drugs involved in the study.
  • Contraindications to central neuraxial anaesthesia.
  • Infection at the site of block.
  • Use of analgesics 8 hours prior to the administration of the block.
  • Subjects with peripheral sensorineural deficits.
  • Patients with poor cognitive function which might lead to difficulties in assessing pain scores.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Time taken for sensory blockade after administration of the blockAt baseline, 1 minute, 3 minutes, 5 minutes, 10 minutes and 15 minutes.
Secondary Outcome Measures
NameTimeMethod
Pain score is assessed using the Numerical Pain Rating ScalePain score will be measured upon arrival of the patient to the premedication area, followed by 1, 3, 5 and 10 minutes after the block administration. Pain score will be assessed again while positioning the patient for subarachnoid block.
Ease for subarachnoid block measures according to the time taken as well as number of attempts of needle insertion.Time measured starting from positioning of the patient for subarachnoid block till drug injection is completed.
Hemodynamic parametersRecorded upon arrival to the premedication area, followed by 1, 3, 5 and 10 minutes after nerve block administration.
Patient satisfaction score measured as per 5-point Likert scaleMeasured after the subarachnoid block has been given.

Trial Locations

Locations (1)

Kasturba Hospital

🇮🇳

Udupi, KARNATAKA, India

Kasturba Hospital
🇮🇳Udupi, KARNATAKA, India
Dr Anirudh Pai P
Principal investigator
9482513447
anirudpai@live.co.uk

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