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

Upper Extremity Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06356415
• Other study ID #: Dex Dex in infraclavicular
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Arm Injuries
• Upper Extremity Injury

Intervention

Drug:
• Bupivacaine injection
Group one will receive infraclavicular block using bupivacaine
• Bupivacaine+ Dexamethasone+ Dexmedetomidine
Group two will receive infraclavicular block using dexamethasone and dexmedetomidine added to the bupivacaine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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