Different Doses of Intravenous Administered Dexamethasone Effecting Brachial Plexus Supraclavicular Block

Different Doses of Intravenous Administered Dexamethasone Effecting Brachial Plexus Supraclavicular Block for Creation of Arteriovenous Fistula in End Stage Renal Disease: A Randomized Controlled Trial

To compare the analgesic properties of ultrasound guided supraclavicular block using ropivacaine 0.5% in arteriovenous fistula creation when used in combination with intravenous administered dexamethasone at 4mg and 8 mg as an adjuvant

Study Overview

• Status: Not yet recruiting
• Conditions: End Stage Renal Failure
• Intervention / Treatment: Drug: supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Adult, age 18 to 65 years End stage renal disease patients for AV fistula creation

Exclusion Criteria:

Not suitable candidate as determined by the primary team Refusal for brachial plexus block History of allergy to dexamethasone or local anesthesia Pregnancy History of previous brachial plexus injury Coagulopathy Local skin site infection Known neuropathy involving the arm undergoing surgery Patients with glucose reading more then 12mmol/

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GROUP DF; supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous dexamethasone 4mg	Drug: supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone; Comparing the onset of sensory, motor block, duration of motor block and analgesic duration
Active Comparator: GROUP DE; supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous dexamethasone 8mg	Drug: supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone; Comparing the onset of sensory, motor block, duration of motor block and analgesic duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare the difference of onset time between sensory and motor block of supraclavicular block between ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg	2 days
To compare the difference in duration of analgesia between supraclavicular block with ropivacaine and IV dexamethasone 4mg with ropivacaine and IV dexamethasone 8mg	2 days

Secondary Outcome Measures

Outcome Measure	Time Frame
To compare the duration difference of the return of motor block between supraclavicular block using ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg	2 days

Collaborators and Investigators

• Sponsor: Hospital Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Ropivacaine
• Other Study ID Numbers: USM/JEPeM/KK/24010061

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