A study to find out how many patients develop hearing loss after getting spinal anaesthesia with different sizes and types of spinal needles.

Not yet recruiting

• Conditions: Disease of digestive system, unspecified, (2) ICD-10 Condition: N30-N39||Other diseases of the urinary system, (3) ICD-10 Condition: K46||Unspecified abdominal hernia,

• Registration Number: CTRI/2019/03/018052
• Lead Sponsor: K Priyadharshini

Brief Summary

This is a randomized controlled double blinded study to compare the occurence of hearing loss following spinal anaesthesia between two sizes of quinckes babcock needle and 27 gauge size pencil point needle among 66 patients undergoing subarachnoid block for lower abdominal and perineal surgeries. The primary outcome of this study is to compare the occurence of hearing loss by pure tone audiometry and the secondary outcome is to find the incidence of post dural puncture headache.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-09-03
• Study Start: 2019-12-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Patient posted for lower abdominal surgeries and perineal surgeries under spinal anaesthesia.

Exclusion Criteria

• ASA III and above physical status 2.
• History of existing hearing disorders(otitis media, Meniere’s disease) 3.
• History of any hearing disorders during preanaesthestic assessment confirmed by audiometry 4.Previously existing but undiagnosed hearing loss 5.
• On ototoxic medications 6.
• History of chronic headache,migraine,tinnitus 7.
• History of cardiac disease 8.
• History of coagulopathies 9.
• Emergency surgeries 10.
• pregnancy 11.
• Previous history of head injury 12.
• Not willing for audiometry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the occurence of hearing loss by pure tone audiometry	Post operative period after spinal anaesthesia

Secondary Outcome Measures

Name	Time	Method
To find the incidence of post dural puncture headache	Post operative period after spinal anaesthesia

Trial Locations

Locations (1)

Shri Sathya Sai Medical College and Research Institute; 🇮🇳 Kancheepuram, TAMIL NADU, India

Shri Sathya Sai Medical College and Research Institute

🇮🇳Kancheepuram, TAMIL NADU, India

K Priyadharshini

Principal investigator

9894395131

priyadebu93@gmail.com