Comparing Two Doses of Spinal Anesthesia on Affected Side of Inguinal Hernia Surgery

Phase 2

Not yet recruiting

• Conditions: Unilateral inguinal hernia, without obstruction or gangrene,

• Registration Number: CTRI/2025/03/082044
• Lead Sponsor: Deen Dayal Upadhyay Hospital

Brief Summary

This is a prospective and interventional randomized comparative study to compare sensory blockade on the operative side with two different doses of 0.5% hyperbaric bupivacaine for unilateral spinal anaesthesia during elective inguinal hernia surgery. Here the patient will be allocated to 2 groups by block randomization with sealed envelope system. One group will be given 7.5mg of 0.5% hyperbaric bupivacaine and the other group will be given 10mg of 0.5% hyperbaric bupivacaine. Level of sensory and motor block will be assessed in both operative and non operative side and non invasive haemodynamic variables (HR, SBP, DBP, MAP) will be observed from standard monitors intra operatively at 0 min, 5 min, 10 min, 20 min, 30 min, and at the end of surgery in both groups will be assessed. Time from end of spinal injection to achieve sensory block up to T10 and motor block score 3 by using modified bromage scale in both groups will be assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-20
• Last Update Posted: 2025-09-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• ASA Physical Status Grade I & II, Patient to be operated for uncomplicated direct or indirect inguinal hernia under spinal anaesthesia.
• BMI between 18 and 25.

Exclusion Criteria

Patient with history of allergy to drugs, Abnormality or infection in lumbar and groin region, Patient having peripheral neuropathy and coagulation disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the level of sensory and motor block in operative side	0, 5, 10, 20, 30 minute, and at the end of surgery

Secondary Outcome Measures

Name	Time	Method
To assess the level of sensory and motor block in both operative and nonoperative side	0, 5, 10, 20, 30 minute, and at the end of surgery
Non-invasive haemodynamic variables (Heart Rate, SBP, DBP, MAP)	0, 5, 10, 20, 30 minute, and at the end of surgery
Time from the end of spinal injection to achieve sensory block upto T10 & motor block score 3 using modified bromage scale in both groups	Recorded in minutes based on the time taken

Trial Locations

Locations (1)

Deen Dayal Upadhyay Hospital; 🇮🇳 West, DELHI, India

Deen Dayal Upadhyay Hospital

🇮🇳West, DELHI, India

Dr Jumna Y

Principal investigator

8943437672

jumna94@gmail.com