Efficacy of Bupivacaine vs Ropivacaine for nerve blocks in upper limb surgeries

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/08/044871
• Lead Sponsor: Dr Phani Vijay

Brief Summary

INTRODUCTION:



Bupivacaine is an amide local anaesthetic frequently used for brachial plexus nerve

block as it offers the advantage of providing a long duration of action and a favourable

ratio of sensory to motor neural block . Bupivacaine binds to the intracellular portion of

sodium channels and blocks sodium influx into nerve cells, which prevents

depolarization. Bupivacaine is metabolized primarily in the liver via conjugation with

glucuronic acid.



Ropivacaine is a long-acting amide local anaesthetic with a potentially improved safety

profile when compared to bupivacaine . Ropivacaine is less lipophilic than bupivacaine

and is less likely to penetrate large myelinated motor fibres, resulting in a relatively

reduced motor blockade. Ropivacaine has a greater degree of motor sensory

differentiation. It has selective action on the pain-transmitting A Delta and C nerves

rather than Aβ fibres, which are involved in motor function.



AIMS AND OBJECTIVES OF THE STUDY:



To compare the efficacy of 20 ml 0.5 % bupivacaine and 20 ml 2 % lignocaine with

adrenaline vs 20 ml 0.75% Ropivacaine and 20 ml 2 % lignocaine with adrenaline.

1. To compare the efficacy in duration of analgesia

2. To compare the onset of sensory and motor blockade and any side effects.

3. To compare the hemodynamic instability



MATERIALS AND METHODS:

60 patients aged between 18-60 years with comparable demographic

variables, undergoing upper extremity surgery under brachial plexus block at

MEDICOVER HOSPITAL,HITECH CITY, HYDERABAD shall be randomly allocated to two

groups of 30 each. Data shall be collected regarding the efficacy of each modality of anaesthesia, tabulated, and statistically analyzed to assess if one form of anaesthesia is superior to the other.



Administration of block:

Supraclavicular, axillarly or interscalene approach shall be used

Ultrasound guidance shall be used.



Data pertaining to efficacy of each anaesthetic agent shall be documented, and analyzed statistically to assess efficacy in various parameters including:

Onset of sensory blockade

Onset of motor blockade

Onset of sensory recovery

Onset of motor recovery

Onset of peak sensory block

Duration of analgesia

Need for rescue analgesia

Hemodynamic stability.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-08-23
• Study Start: 2022-08-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

ASA grade 1 and 2 physical status Scheduled for elective surgery under brachial plexus block No h/o allergy or sensitivity to any of the studied local anaesthetics Patients weighing over 50kg.

Exclusion Criteria

Patients with : Bleeding disorders Neuromuscular disorders Cardiovascular compromise COPD Hepatic dysfunction Renal failure Patient refusal to participate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time duration of analgesia following administration of block shall be assessed in terms of: time after administration of the single shot brachial plexus block- till the time when the patient complains of pain.	After administration of anaesthetic agent, | the patient shall undergo surgery. The presence or absence of pain at the surgical site shall be noted every hour following administration of block- till 6 hours following the block, or till the patient complains of pain- whichever occurs earlier.

Secondary Outcome Measures

Name	Time	Method
Hemodynamic stability	after administration of anaesthesia
Onset of sensory blockade	after administration of anaesthesia
Peak of sensory block	after administration of anaesthesia
onset of motor blockade	after administration of anaesthesia
Onset of sensory recovery	after administration of anaesthesia
Need for rescue analgesia	after administration of anaesthesia
Onset of motor recovery	after administration of anaesthesia
Peak of motor block	after administration of anaesthesia
Visual analog score at 6 hours	6 hours after administration of anaesthesia

Trial Locations

Locations (1)

Medicover Hospitals, Hitech City; 🇮🇳 Hyderabad, TELANGANA, India

Medicover Hospitals, Hitech City

🇮🇳Hyderabad, TELANGANA, India

Dr Phani Vijay

Principal investigator

9666086274

vijjunmaddy@gmail.com