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

NCT06356415 | Not Yet Recruiting

• 1 other identifier: Dex Dex in infraclavicular
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Upper Extremity Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

Patients will undergo an ultrasound-guided infraclavicular brachial plexus block using bupivacaine alone.

Drug: Bupivacaine injection

Bupivacaine+ Dexamethasone+ Dexmedetomidine

ACTIVE COMPARATOR

Patients will undergo an ultrasound-guided infraclavicular brachial plexus block using bupivacaine combined with dexmedetomidine and dexamethasone.

Drug: Bupivacaine+ Dexamethasone+ Dexmedetomidine

Interventions

Bupivacaine injection DRUG

Group one will receive infraclavicular block using bupivacaine

Bupivacaine

Bupivacaine+ Dexamethasone+ Dexmedetomidine DRUG

Group two will receive infraclavicular block using dexamethasone and dexmedetomidine added to the bupivacaine

Bupivacaine+ Dexamethasone+ Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suez Canal University: lead

MeSH Terms

Conditions

Arm Injuries

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The sealed-envelope technique will be used. An assistant who is not involved in patient care will make and combine bupivacaine, whether it contains adjuvants or not. Thus, all patients, operators, and outcome assessors remain blinded to the nature of the perineural adjuvant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Suez Canal University Faculty of Medicine

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 10, 2024
• Study Start: May 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04