Studying the effectiveness of ultrasound-guided caudal block for pain relief after femur fracture surgery with spinal anesthesia.

Phase 4

Recruiting

• Conditions: Unspecified fracture of femur, (2) ICD-10 Condition: S729||Unspecified fracture of femur, (3) ICD-10 Condition: S729||Unspecified fracture of femur, (4) ICD-10 Condition: S729||Unspecified fracture of femur,

• Registration Number: CTRI/2025/04/083840
• Lead Sponsor: Mahatma Gandhi medical college and hospital

Brief Summary

It is a prospective, randomised, hospital based study to be conducted by Department of Anaesthesia, Mahatma Gandhi Medical College & Hospital, Jaipur.

After ethical committee’s approval, informed written consent will be obtained from all patients.

After doing all the required investigation, PAC will be performed a day before the surgery.

Patients will be randomly divided into two groups of 35 each with the help of computer generated randomization tables method. All patients will be explained about the technique.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-01-04
• Study Start: 2025-01-05

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patient scheduled for femur fracture surgeries under subarachnoid block.
• Patient with ASA grade I,II and III.

Exclusion Criteria

• Subject’s refusal to participate in the study Any bleeding disorder or patient on anticoagulants.
• Neurological deficits History of drug allergy.
• Local infection at the injection site.
• Patients on any sedatives or antipsychotics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of pain using VAS ( visual analogue scale ) score at interval of 2hrs for 24hrs between the two groups.	0,2nd hour, 4th hour, 6th hour, 8th hour, 10th hour, 12th hour, 14th hour, 16th hour, 18th hour, 20th hour, 22nd hour, 24th hour.
Group B : The alternative intravenous pain management group (Control group)	0,2nd hour, 4th hour, 6th hour, 8th hour, 10th hour, 12th hour, 14th hour, 16th hour, 18th hour, 20th hour, 22nd hour, 24th hour.
Group A : Ultrasound Guided caudal block group- 0.2% Ropivacaine 0.3-0.5ml/kg	0,2nd hour, 4th hour, 6th hour, 8th hour, 10th hour, 12th hour, 14th hour, 16th hour, 18th hour, 20th hour, 22nd hour, 24th hour.

Secondary Outcome Measures

Name	Time	Method
To assess the time of first rescue analgesia between the two groups.	To assess & compare the total dose required in first 24 hour post- operatively in both patient groups.

Trial Locations

Locations (1)

Mahatma Gandhi Medical College and Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Mahatma Gandhi Medical College and Hospital

🇮🇳Jaipur, RAJASTHAN, India

Dr Lalita Choudhary

Principal investigator

9414038471

lalita16y@gmail.com