A clinical trial to study the effect of addition of drugs Dexmedetomidine and Dexamethasone to regional nerve block of upper extremity surgeries

Not yet recruiting

• Conditions: Diseases of the musculoskeletal system and connective tissue,

• Registration Number: CTRI/2021/08/035448
• Lead Sponsor: Jubilee Mission Medical College and Research Institute

Brief Summary

Pain can result in physiological changes in the intraoperative period and psychological effects postoperatively. Regional anesthesia has been used as a sole anesthesia technique and as supplementary to general anesthesia. The brachial plexus blockade is a time-tested technique for upper limb surgeries. The search for better adjuvants to local anesthetics for nerve blocks for rapid onset, prolonged duration of analgesia and with lesser side effects has been never ending. Various adjuvants like opioids, neostigmine, midazolam, hyaluronidase, alpha 2 adrenergic receptor agonists, corticosteroids, and epinephrine have been used to modify the onset of action, enhance the quality of block, and prolong the duration of post-operative analgesia. In this study, we aim to evaluate Dexmedetomidine and Dexamethasone as adjuvants to Ropivacaine in comparison to Ropivacaine alone for ultrasound guided brachial plexus block. The minimum sample size comes to 25 in each group. In this study, 30 patients will be taken up in each group for proper randomization and exclusion of any patient due to block failure. The study will be conducted in the Department of Anesthesiology, Old block, Jubilee Mission Medical College and Research Institute, Thrissur.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-04-08
• Study Start: 2021-08-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Age from 18 years to 65 years 2.
• American Society of Anaesthesiologists (ASA) physical status class I and II 3.
• Patients scheduled for upper limb surgeries at the level of mid shaft of humerus and below.

Exclusion Criteria

• Patient refusal for study participation 2.
• Local infection at injection site 3.
• Presence of any coagulopathies, bleeding disorders or patients on anticoagulants 4.
• Presence of neurological deficits, peripheral neuropathies, myopathies or chronic pain in the operating limb 5.
• Patients with known allergy to local anaesthetics or to any of the study drugs to be used 6.
• Patients with baseline bradycardia or on beta blockers/alpha agonists 7.
• Hemodynamically compromised patients 8.
• Alcoholic/psychiatric/uncooperative patients 9.
• Pregnant and breast-feeding mothers 10.Patients with diabetes, hepatic/renal or cardiopulmonary disorders 11.Morbid obesity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Onset and duration of sensory and motor blockade	Onset of sensory and motor blockade will be assessed every 3 minutes after the completion of injection upto 60 minutes. | Duration of sensory and motor blockade will be assessed in the first 24 hours after block.

Secondary Outcome Measures

Name	Time	Method
1. Duration of analgesia	2. Hemodynamic parameters during surgery

Trial Locations

Locations (1)

Jubilee Mission Medical College and Research Institute; 🇮🇳 Thrissur, KERALA, India

Jubilee Mission Medical College and Research Institute

🇮🇳Thrissur, KERALA, India

Dr Laveena Basil Consera

Principal investigator

9074506232

laveenabasil94@gmail.com