A STUDY TO COMPARE EFFECTS OF ADDITIVES IN SPINAL ANAESTHESIA IN LOWER LIMB ORTHOPAEDIC SURGERIES : BUPIVACAINE WITH DEXMEDITOMIDINE VS BUPIVACAINE WITH FENTANYL.

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/05/033600
• Lead Sponsor: MGIMS Sevagram

Brief Summary

A Randomised Double Blind Controlled Trail to study the efficacy of intrathecal 0.5% Bupivacaine with Dexmedetomidine vs 0.5% Bupivacaine with Fentanyl in 104 patients of lower limb orthopaedic surgeries. The primary objective is to study the duration of anaesthesia. The secondary objectives are to compare onset of block, level of bock , side effects and postoperative analgesia .

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-07
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• American Society of Anesthesiologists Grade I and II patients.
• Age 20-60 years of either gender.
• Patients undergoing lower limb Surgeries .
• Patients free from cardiac and respiratory dysfunction.
• Height is more than 4 feet.

Exclusion Criteria

• American Society of Anesthesiologists Grade III and IV patients.
• Patients with known contraindications for spinal anaesthesia: bleeding disorders, local infection.
• Patients with haemodynamic instability.
• Patients with comorbidities like Hypertension, Diabetes Mellitus, cardiac diseases,etc.
• Patient with allergy to or history of hypersensitivity to local anaesthetics.
• Emergency surgeries.
• Patient with known allergy to opioids.
• Patients with a history of severe PDPH or PONV after spinal anaesthesia.
• Patient’s refusal.
• Orthopaedic Surgeries requiring level of block above T8.
• Lower limb orthopaedic surgeries around Hip joint.
• Joint replacement surgeries.
• Orthopaedic surgeries requiring prolonged duration of action that will require supplementation with epidural catheterization or general anaesthesia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The objectives of this study is to compare effects of intrathecal 0.5% Bupivacaine with Dexmeditomidine & 0.5% Bupivacaine with Fentanyl in terms of the duration of sensory and motor blockade.	Till 120 minutes

Secondary Outcome Measures

Name	Time	Method
The objectives of this study is to compare effects of intrathecal 0.5% Bupivacaine with Dexmedetomidine & 0.5% Bupivacaine with Fentanyl in terms of The onset of sensory and motor blocks achieved.	The level of blockade achieved .

Trial Locations

Locations (1)

MGIMS; 🇮🇳 Wardha, MAHARASHTRA, India

MGIMS

🇮🇳Wardha, MAHARASHTRA, India

Jidnyasa Moon

Principal investigator

9405903734

jidnyasa09@gmail.com