Infraclavicular Brachial Plexus Block With Bupivacaine Alone or With Both Dexmedetomidine and Dexamethasone

Infraclavicular Brachial Plexus Block Using Bupivacaine Alone or in Combination With Dexmedetomidine and Dexamethasone for Hand and Forearm Surgeries, A Randomized, Controlled Trial

Upper-extremity regional anesthetic techniques, using brachial plexus blockade, have been shown to reduce adverse effects related to opioid administration, improve patient satisfaction, and provide significantly improved analgesia immediately following these surgeries. Many medications have been investigated to extend and enhance long-acting local anesthetics' (LA) analgesic effects. Currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal long-lasting single-shot nerve block. In general, adjuvants have been used in peripheral nerve blocks to accelerate onset, decrease plasmatic absorption and secondary toxic effects, and prolong the block effects.

Study Overview

• Status: Not yet recruiting
• Conditions: Upper Extremity Injury
• Intervention / Treatment: Drug: Bupivacaine injection; Drug: Bupivacaine+ Dexamethasone+ Dexmedetomidine

Detailed Description

Brachial plexus blockade-based upper-extremity regional anesthetic approaches have been demonstrated to lessen opioid administration side effects, increase patient satisfaction, and offer noticeably better analgesia right after these surgeries. A lot of drugs have been tested to prolong and improve the analgesic effect of long-acting local anesthetics (LA). Currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal, long-lasting single-shot nerve block. Adjuvants have generally been employed in peripheral nerve blocks to lengthen the block effects, limit secondary toxic effects and plasmatic absorption, and speed the onset of the block. Objectives: To compare the effects of adding dexmedetomidine and dexamethasone to bupivacaine on the start of sensory blockade in an infraclavicular brachial plexus block. Patients and Methods: A prospective, randomized controlled trial will be conducted on patients who are undergoing hand or forearm surgeries. Patients who will be eligible for the study will be divided into 2 groups. The first group will receive dexmedetomidine and dexamethasone as adjuvants to bupivacaine, while the second group will receive bupivacaine alone. Expected Results: The success rate, onset time, duration of the block, and possible adverse events.

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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age 18-65 years
• American Society of Anesthesiologists physical status I-II
• Body mass index between 18 and 35 kg/ m2
• scheduled for forearm and hand surgeries

Exclusion Criteria:

• Inability to consent to the study
• Coagulopathy
• Sepsis
• Decompensated chronic hepatic or renal illnesses
• Allergy to any of the used drugs
• Pre-existing musculocutaneous/median/radial/ ulnar neuropathy
• Prior surgery in the infraclavicular fossa

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine; Patients will undergo an ultrasound-guided infraclavicular brachial plexus block using bupivacaine alone.	Drug: Bupivacaine injection; Group one will receive infraclavicular block using bupivacaine
Active Comparator: Bupivacaine+ Dexamethasone+ Dexmedetomidine; Patients will undergo an ultrasound-guided infraclavicular brachial plexus block using bupivacaine combined with dexmedetomidine and dexamethasone.	Drug: Bupivacaine+ Dexamethasone+ Dexmedetomidine; Group two will receive infraclavicular block using dexamethasone and dexmedetomidine added to the bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of sensory block	Comparing the number of minutes required to achieve total upper limb sensory blockade following the application of an infraclavicular brachial plexus block that includes both dexmedetomidine and dexamethasone in addition to bupivacaine, as opposed to merely using bupivacaine on its own.	Immediately after the performance of the infraclavicular block

Collaborators and Investigators

• Sponsor: Suez Canal University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexamethasone; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: Dex Dex in infraclavicular

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No