Effect of Dexmedetomidine as Adjuvant to Ropivacaine for Brachial Plexus Block

Brachial plexus block is used for upper limb surgery. Local anesthesia alone for brachial plexus block provides good operative conditions, but have short duration of postoperative analgesia. Hence, various adjuvants to local anaesthetic agents to prolong the duration of peripheral nerve, analgesia. However, results are either inconclusive or associated with side effects. The purpose of this study is to determine whether dexmedetomidine as an adjuvant to ropivacaine in brachial plexus block improve quality of block in terms of duration of post operative analgesia.

Study Overview

• Status: Recruiting
• Conditions: Brachial Plexus Block; Upper Extremity Fracture; Local Anesthesia Adjuvants
• Intervention / Treatment: Drug: ropivacaine, lidocaine with adrenaline; Drug: Dexmedetomidine, ropivacaine, lidocaine with adrenaline

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rajiv Yadav, MD ANESTHESIA; Phone Number: 9816826324; Email: munnaraj2042@gmail.com

Study Locations

• Nepal
  • Bagmati
    • Kathmandu, Bagmati, Nepal, 0096
      • Recruiting
      • Nepal medical college
      • Contact: Rajiv Yadav, MD anaesthesia; Phone Number: 9816826324; Email: Munnaraj2042@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA physical status I and II patients, weight 45 to 74 kg
• Elective upper limb surgery under brachial plexus block

Exclusion Criteria:

• known hypersensitivity or contraindication to ropivacaine, lidocaine and dexmedetomidine
• Pregnant or lactating mothers
• Hepatic, renal or cardiopulmonary abnormalities
• Long term analgesic therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group R; 0.35% ropivacaine 20ml, 1.5% lidocaine with adrenaline 10ml = 30 ml	Drug: ropivacaine, lidocaine with adrenaline; Group R includes 0.35% ropivacaine 20ml, 1.5 % lidocaine with adrenaline 10ml
Experimental: Group RD; 0.35% ropivacaine and 1mcg/ kg dexmedetomidine (20 ml), 1.5% lidocaine with adrenaline (10ml) = 30 ml	Drug: Dexmedetomidine, ropivacaine, lidocaine with adrenaline; Dexmedetomidine 1mcg/kg and 0.35% ropivacaine with normal saline (20ml), 1.5% lidocaine with adrenaline (10ml) in group RD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the duration of analgesia after brachial plexus block with ropivacaine and dexmedetomidine	Analgesia will be assessed with the help of Visual analogue score ( VAS). VAS greater than 3 will be given inj.ketorolac 30mg IV.	5 months
Assess the onset of sensory and motor block after brachial plexus block with ropivacaine and dexmedetomidine	Sensory block assessed by 3point scale 0 normal sensation; loss of sensation of pinprick; loss of sensation of touch Duration of sensory block, defined as time interval between complete sensory block and complete resolution of anesthesia (score 0).Motor blockade assessed by modified Bromage scale (MBS) 0-able to raise extended arm to 90 degree for full two seconds; able to flex elbow, move fingers but unable to raise extended arm; unable to flex elbow but able to move fingers; unable to move arm, elbow, fingers Duration of motor block defined as time interval from complete motor block to recovery of complete motor function (MBS 0).	5 months
Assess the duration of sensory and motor block after brachial plexus block with ropivacaine and dexmedetomidine	Duration of sensory block, defined as time interval between complete sensory block and complete resolution of anesthesia (score 0). Duration of motor block defined as time interval from complete motor block to recovery of complete motor function (MBS 0).	5months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess any complications of study drugs	Complications like bradycardia assessed by continue ECG monitoring, Hypotension will be assessed by NIBP	5 months

Collaborators and Investigators

• Sponsor: Nepal Medical College and Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): July 30, 2023

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: March 11, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 11, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Dexmedetomidine; Lidocaine; Ropivacaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: NepalMCTH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No